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    Synopsis

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    Chemistry

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    Also known as: 114977-28-5, Taxotere, Docetaxel anhydrous, Docetaxol, Rp-56976, Docetaxel winthrop
    Molecular Formula
    C43H53NO14
    Molecular Weight
    807.9  g/mol
    InChI Key
    ZDZOTLJHXYCWBA-VCVYQWHSSA-N
    FDA UNII
    699121PHCA
    Docetaxel
    A semisynthetic analog of PACLITAXEL used in the treatment of locally advanced or metastatic BREAST NEOPLASMS and NON-SMALL CELL LUNG CANCER.
    Docetaxel anhydrous is a Microtubule Inhibitor. The physiologic effect of docetaxel anhydrous is by means of Microtubule Inhibition.
    1 2D Structure

    Docetaxel

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4-acetyloxy-1,9,12-trihydroxy-15-[(2R,3S)-2-hydroxy-3-[(2-methylpropan-2-yl)oxycarbonylamino]-3-phenylpropanoyl]oxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.03,10.04,7]heptadec-13-en-2-yl] benzoate
    2.1.2 InChI
    InChI=1S/C43H53NO14/c1-22-26(55-37(51)32(48)30(24-15-11-9-12-16-24)44-38(52)58-39(3,4)5)20-43(53)35(56-36(50)25-17-13-10-14-18-25)33-41(8,34(49)31(47)29(22)40(43,6)7)27(46)19-28-42(33,21-54-28)57-23(2)45/h9-18,26-28,30-33,35,46-48,53H,19-21H2,1-8H3,(H,44,52)/t26-,27-,28+,30-,31+,32+,33-,35-,41+,42-,43+/m0/s1
    2.1.3 InChI Key
    ZDZOTLJHXYCWBA-VCVYQWHSSA-N
    2.1.4 Canonical SMILES
    CC1=C2C(C(=O)C3(C(CC4C(C3C(C(C2(C)C)(CC1OC(=O)C(C(C5=CC=CC=C5)NC(=O)OC(C)(C)C)O)O)OC(=O)C6=CC=CC=C6)(CO4)OC(=O)C)O)C)O
    2.1.5 Isomeric SMILES
    CC1=C2[C@H](C(=O)[C@@]3([C@H](C[C@@H]4[C@]([C@H]3[C@@H]([C@@](C2(C)C)(C[C@@H]1OC(=O)[C@@H]([C@H](C5=CC=CC=C5)NC(=O)OC(C)(C)C)O)O)OC(=O)C6=CC=CC=C6)(CO4)OC(=O)C)O)C)O
    2.2 Other Identifiers
    2.2.1 UNII
    699121PHCA
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Docetaxel Anhydrous

    2. Docetaxel Hydrate

    3. Docetaxel Trihydrate

    4. Docetaxol

    5. N Debenzoyl N Tert Butoxycarbonyl 10 Deacetyltaxol

    6. N-debenzoyl-n-tert-butoxycarbonyl-10-deacetyltaxol

    7. Nsc 628503

    8. Rp 56976

    9. Rp-56976

    10. Rp56976

    11. Taxoltere Metro

    12. Taxotere

    2.3.2 Depositor-Supplied Synonyms

    1. 114977-28-5

    2. Taxotere

    3. Docetaxel Anhydrous

    4. Docetaxol

    5. Rp-56976

    6. Docetaxel Winthrop

    7. Docetaxel [inn]

    8. Emdoc

    9. Docefrez

    10. Nsc 628503

    11. N-debenzoyl-n-tert-butoxycarbonyl-10-deacetyltaxol

    12. Rp 56976

    13. Txl

    14. Taxotere (tn)

    15. Nsc-628503

    16. N-debenzoyl-n-(tert-butoxycarbonyl)-10-deacetyltaxol

    17. Chebi:4672

    18. 699121phca

    19. Nsc628503

    20. N-debenzoyl-n-(tert-butoxycarbonyl)-10-deacetylpaclitaxel

    21. Dsstox_cid_20464

    22. Dsstox_rid_79497

    23. Dsstox_gsid_40464

    24. (2alpha,5beta,7beta,10beta,13alpha)-4-(acetyloxy)-13-({(2r,3s)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1,7,10-trihydroxy-9-oxo-5,20-epoxytax-11-en-2-yl Benzoate

    25. [(1s,2s,3r,4s,7r,9s,10s,12r,15s)-4-acetyloxy-1,9,12-trihydroxy-15-[(2r,3s)-2-hydroxy-3-[(2-methylpropan-2-yl)oxycarbonylamino]-3-phenylpropanoyl]oxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.03,10.04,7]heptadec-13-en-2-yl] Benzoate

    26. Docetaxel, Trihydrate

    27. Taxotel

    28. Docetaxolum

    29. Taxoel

    30. Docetaxel Kabi

    31. Docetaxel Intermediate

    32. Bind 014

    33. Taxotere(r)

    34. Ckd-810

    35. (1s,2s,3r,4s,7r,9s,10s,12r,15s)-4-(acetyloxy)-15-{[(2r,3s)-3-{[(tert-butoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoyl]oxy}-1,9,12-trihydroxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.0^{3,10}.0^{4,7}]heptadec-13-en-2-yl Benzoate

    36. (2ar,4s,4as,6r,9s,11s,12s,12ar,12bs)-12b-acetoxy-9-(((2r,3s)-3-((tert-butoxycarbonyl)amino)-2-hydroxy-3-phenylpropanoyl)oxy)-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-1h-7,11-methanocyclodeca[3,4]benzo[1,2-b]oxet-12-yl Benzoate

    37. Cas-114977-28-5

    38. Docetaxolum [inn-latin]

    39. Docecad

    40. Unii-699121phca

    41. Docetaxel Teva

    42. Docetaxel Accord

    43. Mfcd00871399

    44. Docetaxel 114977-28-5

    45. Dtxsid0040464

    46. Hsdb 6965

    47. Xrp-6976l

    48. Anx-514

    49. Sdp-014

    50. Sid 530

    51. Docetaxel (tn)

    52. Docetaxel- Bio-x

    53. Ncgc00181306-01

    54. Ncgc00181306-02

    55. 5?,20-epoxy-1,7?,10?-trihydroxy-9-oxotax-11-ene-2?,4,13?-triyl 4-acetate 2-benzoate 13-[(2r,3s)-3-[[(1,1-dimethylethoxy)carbonyl]amino]-2-hydroxy-3-phenylpropanoate]

    56. Taxotere (aventis)

    57. Docetaxel, Anhydrous

    58. Cid148124

    59. N-debenzoyl-n-boc-10-deacetyl Taxol

    60. Docetaxel - Taxotere

    61. Docetaxel Mylan

    62. Rp56976

    63. Bind-014

    64. Docetaxel (jan/inn)

    65. Docetaxel [jan]

    66. Docetaxel [mi]

    67. Chembl92

    68. Docetaxel [hsdb]

    69. Schembl4419

    70. Docetaxel Teva Pharma

    71. Gtpl6809

    72. Bind 014 [who-dd]

    73. Bdbm36351

    74. Syp-0704a

    75. Zdzotljhxycwba-vcvyqwhssa-

    76. Amy4356

    77. 114977-28-5, Docetaxel

    78. Hms2089k08

    79. Ex-a1206

    80. Hy-b0011

    81. Tox21_112781

    82. Tox21_113088

    83. Ac-383

    84. Docetaxel Anhydrous [who-dd]

    85. Zinc85537053

    86. Akos015960718

    87. Akos024457953

    88. Tox21_112781_1

    89. Cs-1144

    90. Db01248

    91. Ks-1452

    92. Isocyanatoethylmethacrylatepolymer

    93. Docetaxel, Purum, >=97.0% (hplc)

    94. Ncgc00181306-04

    95. Ncgc00242509-01

    96. 4-(acetyloxy)-13alpha-({(2r,3s)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1,7beta,10beta-trihydroxy-9-oxo-5beta,20-epoxytax-11-en-2alpha-yl Benzoate

    97. Bd164373

    98. Benzenepropanoic Acid, Beta-(((1,1-dimethylethoxy)carbonyl)amino)-alpha-hydroxy-, 12b-(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1h-cyclodeca(3,4)benz(1,2-b)oxet-9-yl Ester

    99. Cabazitaxel Metabolite (rp56976)

    100. D4102

    101. D07866

    102. Ab01273941-01

    103. Ab01273941-02

    104. Q420436

    105. Sr-01000003023

    106. W-60384

    107. Q-100074

    108. Sr-01000003023-5

    109. Brd-k30577245-001-04-3

    110. Brd-k30577245-341-01-9

    111. Z1551429742

    112. Anhydrous Docetaxel, European Pharmacopoeia (ep) Reference Standard

    113. (2ar,4s,4as,6r,9s,11s,12s,12ar,12bs)-12b-(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1h-cyclodeca[3,4]benz[1,2-b]oxet-9-yl (ar,bs)-b-[[(1,1-dimethylethoxy)carbonyl]amino]-a-hydroxybenzenepropanoate

    114. (2beta,5beta,7alpha,8alpha,10alpha,13alpha)-4-(acetyloxy)-13-({(2r,3s)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1,7,10-trihydroxy-9-oxo-5,20-epoxytax-11-en-2-yl Benzoate

    115. (2r,3s)-n-carboxy-3-phenylisoserine, N-tert-butyl Ester, 13-ester With 5.beta.,20-epoxy-1,2.alpha.,4,7.beta.,10.beta.,13.alpha.-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate

    116. [2ar-[2a?,4?,4a?,6?,9?(?r*,?s*),11?,12?,12a?,12b?]]-?-[[(1,1-dimethylethoxy)carbonyl]amino]-?-hydroxy-12b-(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1h-cyclodeca[3,4]benz[1,2-b]oxet-9-yl Ester Benzenepropanoic Acid

    117. [acetoxy-[(2r,3s)-3-(tert-butoxycarbonylamino)-2-hydroxy-3-phenyl-propanoyl]oxy-trihydroxy-tetramethyl-oxo-[?]yl] Benzoate

    118. 114915-20-7

    119. Benzenepropanoic Acid, Beta-(((1,1-dimethylethoxy)carbonyl)amino)-alpha-hydroxy-, (2ar,4s,4as,6r,9s,11s,12s,12ar,12bs)-12b-(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1h-cyclodeca(3,4)benz(1,2-b)oxet-9-yl Ester, (alphar,betas)-

    120. Benzenepropanoic Acid,1-dimethylethoxy)carbonyl]amino]-.alpha.-hydroxy-, (2ar,4s,4as,6r,9s,11s,12s,12ar,12bs)-12b-(acetyloxy)-12-(benzyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1h-cyclodeca[3,4]benz[1,2-b]oxet-9-yl Ester, (.alpha.r,.beta.s)

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 807.9 g/mol
    Molecular Formula C43H53NO14
    XLogP31.6
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count14
    Rotatable Bond Count13
    Exact Mass807.34660536 g/mol
    Monoisotopic Mass807.34660536 g/mol
    Topological Polar Surface Area224 Ų
    Heavy Atom Count58
    Formal Charge0
    Complexity1660
    Isotope Atom Count0
    Defined Atom Stereocenter Count11
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameDocefrez
    PubMed HealthDocetaxel (Injection)
    Drug ClassesAntineoplastic Agent
    Active IngredientDocetaxel
    Dosage FormInjectable
    RouteInjection
    Strength80mg/vial; 20mg/vial
    Market StatusPrescription
    CompanySun Pharma Global

    2 of 6  
    Drug NameDocetaxel
    Drug LabelDocetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylis...
    Active IngredientDocetaxel
    Dosage FormInjectable
    RouteInjection
    Strength160mg/16ml (10mg/ml); 130mg/13ml (10mg/ml); 80mg/4ml (20mg/ml); 200mg/20ml (10mg/ml); 80mg/8ml (10mg/ml); 20mg/2ml (10mg/ml); 80mg/2ml (40mg/ml); 160mg/8ml (20mg/ml); 20mg/ml (20mg/ml); 140mg/7ml (20mg/ml); 20mg/0.5ml (40mg/ml)
    Market StatusPrescription
    CompanyHospira; Accord Hlthcare; Pfizer Labs; Sandoz; Actavis

    3 of 6  
    Drug NameTaxotere
    PubMed HealthDocetaxel (Injection)
    Drug ClassesAntineoplastic Agent
    Drug LabelDocetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylis...
    Active IngredientDocetaxel
    Dosage FormInjectable
    RouteInjection
    Strength160mg/8ml (20mg/ml); 80mg/4ml (20mg/ml); 20mg/ml (20mg/ml)
    Market StatusPrescription
    CompanySanofi Aventis Us

    4 of 6  
    Drug NameDocefrez
    PubMed HealthDocetaxel (Injection)
    Drug ClassesAntineoplastic Agent
    Active IngredientDocetaxel
    Dosage FormInjectable
    RouteInjection
    Strength80mg/vial; 20mg/vial
    Market StatusPrescription
    CompanySun Pharma Global

    5 of 6  
    Drug NameDocetaxel
    Drug LabelDocetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylis...
    Active IngredientDocetaxel
    Dosage FormInjectable
    RouteInjection
    Strength160mg/16ml (10mg/ml); 130mg/13ml (10mg/ml); 80mg/4ml (20mg/ml); 200mg/20ml (10mg/ml); 80mg/8ml (10mg/ml); 20mg/2ml (10mg/ml); 80mg/2ml (40mg/ml); 160mg/8ml (20mg/ml); 20mg/ml (20mg/ml); 140mg/7ml (20mg/ml); 20mg/0.5ml (40mg/ml)
    Market StatusPrescription
    CompanyHospira; Accord Hlthcare; Pfizer Labs; Sandoz; Actavis

    6 of 6  
    Drug NameTaxotere
    PubMed HealthDocetaxel (Injection)
    Drug ClassesAntineoplastic Agent
    Drug LabelDocetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylis...
    Active IngredientDocetaxel
    Dosage FormInjectable
    RouteInjection
    Strength160mg/8ml (20mg/ml); 80mg/4ml (20mg/ml); 20mg/ml (20mg/ml)
    Market StatusPrescription
    CompanySanofi Aventis Us

    4.2 Therapeutic Uses

    Antineoplastic Agents; Tubulin Modulators

    National Library of Medicine's Medical Subject Headings. Docetaxel. Online file (MeSH, 2014). Available from, as of December 18, 2014: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    Taxotere is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. /Included in US product labeling/

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    Taxotere as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition. /Included in US product labeling/

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    Taxotere in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer. /Included in US product labeling/

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    For more Therapeutic Uses (Complete) data for DOCETAXEL (8 total), please visit the HSDB record page.

    4.3 Drug Warning

    /BOXED WARNING/ WARNING: TOXIC DEATHS. The incidence of treatment-related mortality associated with Taxotere therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive Taxotere as a single agent at a dose of 100 mg/sq m.

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    /BOXED WARNING/ WARNING: HEPATOTOXICITY. Taxotere should not be given to patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 x ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death. Bilirubin, AST or ALT, and alkaline phosphatase values should be obtained prior to each cycle of Taxotere therapy

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    /BOXED WARNING/ WARNING: NEUTROPENIA. Taxotere therapy should not be given to patients with neutrophil counts of <1500 cells/cu mm. In order to monitor the occurrence of neutropenia, which may be severe and result in infection, frequent blood cell counts should be performed on all patients receiving Taxotere.

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    /BOXED WARNING/ WARNING: HYPERSENSITIVITY REACTIONS. Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received a 3-day dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the Taxotere infusion and administration of appropriate therapy Taxotere must not be given to patients who have a history of severe hypersensitivity reactions to Taxotere or to other drugs formulated with polysorbate 80.

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    For more Drug Warnings (Complete) data for DOCETAXEL (45 total), please visit the HSDB record page.

    4.4 Drug Indication

    For the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Also used as a single agent in the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. It is also used in combination with prednisone, in the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer. Furthermore, docetaxel has uses in the treatment of gastric adenocarinoma and head and neck cancer.

    FDA Label

    * Breast cancer :

    Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

    - operable node-positive breast cancer ;

    - operable node-negative breast cancer .

    For patients with operable node-negative breast cancer , adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer .

    Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

    Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

    Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.

    Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

    * Non-small-cell lung cancer :

    Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.

    Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer , in patients who have not previously received chemotherapy for this condition.

    * Prostate cancer :

    Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer .

    * Gastric adenocarcinoma:

    Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

    * Head and neck cancer :

    Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

    * Breast cancer :

    Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

    - operable node-positive breast cancer ;

    - operable node-negative breast cancer .

    For patients with operable node-negative breast cancer , adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer .

    Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

    Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

    Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.

    Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

    * Non-small-cell lung cancer :

    Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.

    Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer , in patients who have not previously received chemotherapy for this condition.

    * Prostate cancer :

    Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer .

    * Gastric adenocarcinoma:

    Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

    * Head and neck cancer :

    Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

    * Breast cancer :

    Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

    - operable node-positive breast cancer ;

    - operable node-negative breast cancer .

    For patients with operable node-negative breast cancer , adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer .

    Docetaxel Winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

    Docetaxel Winthrop monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

    Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.

    Docetaxel Winthrop in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

    * Non-small-cell lung cancer :

    Docetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.

    Docetaxel Winthrop in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer , in patients who have not previously received chemotherapy for this condition.

    * Prostate cancer :

    Docetaxel Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer .

    * Gastric adenocarcinoma:

    Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

    * Head and neck cancer :

    Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

    * Breast cancer :

    Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

    - operable node-positive breast cancer ;

    - operable node-negative breast cancer .

    For patients with operable node-negative breast cancer , adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer .

    Taxespira in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

    Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

    Taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.

    Taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

    * Non-small cell lung cancer :

    Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

    Taxespira in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer , in patients who have not previously received chemotherapy for this condition.

    * Prostate cancer :

    Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer .

    * Gastric adenocarcinoma:

    Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

    * Head and neck cancer :

    Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

    * Breast cancer :

    Docetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

    - operable node-positive breast cancer ;

    - operable node-negative breast cancer .

    For patients with operable node-negative breast cancer , adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer .

    Docetaxel Teva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

    Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.

    Previous chemotherapy should have included an anthracycline or an alkylating agent.

    Docetaxel Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.

    Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

    * Non-small-cell lung cancer :

    Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.

    Docetaxel Teva in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer , in patients who have not previously received chemotherapy for this condition.

    * Prostate cancer :

    Docetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer .

    * Gastric adenocarcinoma:

    Docetaxel Teva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

    * Head and neck cancer :

    Docetaxel Teva in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

    * Breast cancer :

    Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

    - operable node-positive breast cancer ;

    - operable node-negative breast cancer .

    For patients with operable node-negative breast cancer , adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer .

    Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

    Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

    Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.

    Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

    * Non-small-cell lung cancer :

    Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.

    Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer , in patients who have not previously received chemotherapy for this condition.

    * Prostate cancer :

    Docetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer .

    Docetaxel Kabi in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer .

    * Gastric adenocarcinoma:

    Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

    * Head and neck cancer :

    Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

    Treatment of breast cancer , special forms of lung cancer (non-small-cell lung cancer ), prostate cancer , gastric cancer , or head and neck cancer .

    * Breast cancer :

    Docetaxel Teva Pharma monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

    * Non-small-cell lung cancer :

    Docetaxel Teva Pharma is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.

    Docetaxel Teva Pharma in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer , in patients who have not previously received chemotherapy for this condition.

    * Prostate cancer :

    Docetaxel Teva Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer .

    Breast cancer

    Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer .

    Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

    Docetaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

    Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.

    Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

    Non-small cell lung cancer

    Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

    Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer , in patients who have not previously received chemotherapy for this condition.

    Prostate cancer

    Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer .

    Gastric adenocarcinoma

    Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

    Head and neck cancer

    Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

    Nasopharyngeal carcinoma

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Docetaxel is a taxoid antineoplastic agent. It promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. In addition, docetaxel induces abnormal arrays or "bundles" of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

    5.2 MeSH Pharmacological Classification

    Tubulin Modulators

    Agents that interact with TUBULIN to inhibit or promote polymerization of MICROTUBULES. (See all compounds classified as Tubulin Modulators.)

    Antineoplastic Agents

    Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    DOCETAXEL ANHYDROUS
    5.3.2 FDA UNII
    699121PHCA
    5.3.3 Pharmacological Classes
    Microtubule Inhibitor [EPC]; Microtubule Inhibition [PE]
    5.4 ATC Code

    L01CD02

    L01CD02

    L01CD02

    L01CD02

    L01CD02

    L01CD02

    L01CD02

    L01CD02

    L01CD02

    L01CD02

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01C - Plant alkaloids and other natural products

    L01CD - Taxanes

    L01CD02 - Docetaxel

    5.5 Absorption, Distribution and Excretion

    Absorption

    The pharmacokinetic profile is consistent with a three-compartment model. The area under the curve (AUC) was dose proportional following doses of 70 mg/m2 to 115 mg/m2 with infusion times of 1 to 2 hours.

    Route of Elimination

    Docetaxel was eliminated in both the urine and feces following oxidative metabolism of the tert-butyl ester group, but fecal excretion was the main elimination route. Within 7 days, urinary and fecal excretion accounted for approximately 6% and 75% of the administered radioactivity, respectively.

    Volume of Distribution

    The initial rapid decline represents distribution to the peripheral compartments and the late (terminal) phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment.

    113 L

    Clearance

    21 L/h/m2 [Total body clearance, cancer patients after IV administration of 20115 mg/m2]

    The initial rapid decline represents distribution to the peripheral compartments and the late (terminal) phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment. Mean steady state volume of distribution was 113 L. In vitro studies showed that docetaxel is about 94% protein bound, mainly to alpha1-acid glycoprotein, albumin, and lipoproteins. In three cancer patients, the in vitro binding to plasma proteins was found to be approximately 97%. Dexamethasone does not affect the protein binding of docetaxel.

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    A study of (14)C-docetaxel was conducted in three cancer patients. Docetaxel was eliminated in both the urine and feces following oxidative metabolism of the tert-butyl ester group, but fecal excretion was the main elimination route. Within 7 days, urinary and fecal excretion accounted for approximately 6% and 75% of the administered radioactivity, respectively. About 80% of the radioactivity recovered in feces is excreted during the first 48 hours as 1 major and 3 minor metabolites with very small amounts (less than 8%) of unchanged drug.

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20 mg/m2 to 115 mg/sq m in phase 1 studies. The area under the curve (AUC) was dose proportional following doses of 70 mg/sq m to 115 mg/sq m with infusion times of 1 to 2 hours. Docetaxel's pharmacokinetic profile is consistent with a three-compartment pharmacokinetic model, with half-lives for the alpha, beta, and gamma phases of 4 min, 36 min, and 11.1 hr, respectively. Mean total body clearance was 21 L/hr/sq m.

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    It is not known whether docetaxel is excreted in human milk.

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    5.6 Metabolism/Metabolites

    Hepatic. In vitro drug interaction studies revealed that docetaxel is metabolized by the CYP3A4 isoenzyme (1 major, 3 minor metabolites).

    Docetaxel, a potent antimicrotubule agent widely used in the treatment of ovarian, breast and lung cancer, is extensively metabolized in various animal species, including humans. The metabolism of docetaxel to its primary metabolite, hydroxydocetaxel, is mediated by cytochrome P450 isozymes CYP3A2 and CYP3A4 in rats and humans, respectively....

    PMID:11561777 Nallani SC et al; Cancer Chemother Pharmacol 48 (2): 115-22 (2001)

    In vitro drug interaction studies revealed that docetaxel is metabolized by the CYP3A4 isoenzyme, and its metabolism may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4.

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    Docetaxel has known human metabolites that include Hydroxy-Docetaxel.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.7 Biological Half-Life

    Dose-dependent. Doses of 70 mg per square meter of body surface area (mg/m 2 ) or higher produce a triphasic elimination profile. With lower doses, assay limitations precluded detection of the terminal elimination phase. The half-life of the alpha, beta, and gamma phase are 4 minutes, 36 minutes, and 11.1 hours, respectively.

    5.8 Mechanism of Action

    Docetaxel interferes with the normal function of microtubule growth. Whereas drugs like colchicine cause the depolymerization of microtubules in vivo, docetaxel arrests their function by having the opposite effect; it hyper-stabilizes their structure. This destroys the cell's ability to use its cytoskeleton in a flexible manner. Specifically, docetaxel binds to the β-subunit of tubulin. Tubulin is the "building block" of microtubules, and the binding of docetaxel locks these building blocks in place. The resulting microtubule/docetaxel complex does not have the ability to disassemble. This adversely affects cell function because the shortening and lengthening of microtubules (termed dynamic instability) is necessary for their function as a transportation highway for the cell. Chromosomes, for example, rely upon this property of microtubules during mitosis. Further research has indicated that docetaxel induces programmed cell death (apoptosis) in cancer cells by binding to an apoptosis stopping protein called Bcl-2 (B-cell leukemia 2) and thus arresting its function.

    Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. This leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, which results in the inhibition of mitosis in cells. Docetaxel's binding to microtubules does not alter the number of protofilaments in the bound microtubules, a feature which differs from most spindle poisons currently in clinical use.

    NIH; DailyMed. Current Medication Information for Taxotere (Docetaxel) Injection, Solution, Concentrate (Updated: November 2014). Available from, as of March 25, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636

    Docetaxel, a semisynthetic taxane, has exhibited significant single-agent activity against prostatic tumors. In phase I/II studies, single-agent docetaxel and the combination of docetaxel plus estramustine were effective in inducing prostate-specific antigen reductions of > or = 50% in men with androgen-independent prostate cancer (AIPC). The underlying reason for docetaxel's clinical activity against prostate cancer has been a focus of ongoing research. Docetaxel is believed to have a twofold mechanism of antineoplastic activity: (1) inhibition of microtubular depolymerization, and (2) attenuation of the effects of bcl-2 and bcl-xL gene expression. Taxane-induced microtubule stabilization arrests cells in the G(2)M phase of the cell cycle and induces bcl-2 phosphorylation, thereby promoting a cascade of events that ultimately leads to apoptotic cell death. In preclinical studies, docetaxel had a higher affinity for tubulin and was shown to be a more potent inducer of bcl-2 phosphorylation than paclitaxel. Laboratory evidence also supports the clinical evaluation of docetaxel-based combinations that include agents such as trastuzumab and/or estramustine. The pathways for docetaxel-induced apoptosis appear to differ in androgen-dependent and androgen-independent prostate cancer cells. Further elucidation of these differences will be instrumental in designing targeted regimens for the treatment of localized and advanced prostate cancer.

    Pienta KJ; Semin Oncol 28 (4 Suppl 15): 3-7 (2001)

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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-23

    Pay. Date : 2012-11-08

    DMF Number : 23054

    Submission : 2009-08-19

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF CA, ASMF arrow-down
    ✖
    Available Reg Filing : CA, ASMF
    AUDIT
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    09

    Samyang Biopharmaceuticals

    South Korea

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ISPE Europe
    Not Confirmed
    arrow

    Samyang Biopharmaceuticals

    South Korea

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    ISPE Europe
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25672

    Submission : 2012-01-04

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2012-240 - Rev 01

    Issue Date : 2014-06-26

    Type : Chemical

    Substance Number : 2449

    Status : Expired

     JDMF arrow-down
    ✖

    Registration Number : 224MF10143

    Registrant's Address : 31 Jongno 33-gil, Jongno-gu, Seoul, Korea

    Initial Date of Registration : 2012-07-31

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    10

    Samyang Biopharmaceuticals

    South Korea

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    ISPE Europe
    Not Confirmed
    arrow

    Samyang Biopharmaceuticals

    South Korea

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    ISPE Europe
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25678

    Submission : 2012-01-04

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    USDMF

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    Phyton Biotech Llc

    Canada
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    BioJapan
    Attending
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    • EDQM
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    Virtual BoothPhyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

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    Digital Content Digital Content

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-11-13

    Pay. Date : 2013-02-22

    DMF Number : 24675

    Submission : 2011-02-15

    Status : Active

    Type : II

    Phyton Company Banner

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    02

    Teva Pharmaceutical Industries Ltd

    Israel
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    TIDES USA
    Attending
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    • EDQM
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    Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-23

    Pay. Date : 2012-11-08

    DMF Number : 23054

    Submission : 2009-08-19

    Status : Active

    Type : II

    TAPI Company Banner

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    03

    Accord Healthcare Inc

    United Kingdom

    USDMF

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    ISPE Europe
    Not Confirmed

    03

    Accord Healthcare Inc

    United Kingdom
    arrow
    ISPE Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21930

    Submission : 2008-10-23

    Status : Inactive

    Type : II

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    04

    Accord Healthcare Inc

    United Kingdom

    USDMF

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    ISPE Europe
    Not Confirmed

    04

    Accord Healthcare Inc

    United Kingdom
    arrow
    ISPE Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20608

    Submission : 2007-06-11

    Status : Inactive

    Type : II

    blank

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    05

    ISPE Europe
    Not Confirmed

    05

    Benzochem Lifesciences Pvt Ltd

    India
    arrow
    ISPE Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21275

    Submission : 2008-01-22

    Status : Inactive

    Type : II

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    06

    Biovectra Inc

    Canada

    USDMF

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    ISPE Europe
    Not Confirmed

    06

    Biovectra Inc

    Canada
    arrow
    ISPE Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21517

    Submission : 2008-04-09

    Status : Active

    Type : II

    blank

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    07

    ISPE Europe
    Not Confirmed

    07

    Hubei Haosun Pharmaceutical Co Ltd

    China
    arrow
    ISPE Europe
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2019-09-12

    Pay. Date : 2019-09-06

    DMF Number : 22562

    Submission : 2009-02-26

    Status : Active

    Type : II

    blank

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    08

    ISPE Europe
    Not Confirmed

    08

    Polymed Therapeutics Inc

    U.S.A
    arrow
    ISPE Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21040

    Submission : 2007-11-15

    Status : Inactive

    Type : II

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    09

    ISPE Europe
    Not Confirmed

    09

    Polymed Therapeutics Inc

    U.S.A
    arrow
    ISPE Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20961

    Submission : 2007-10-22

    Status : Inactive

    Type : II

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    10

    Scinopharm Taiwan Ltd

    Taiwan

    USDMF

    arrow
    ISPE Europe
    Not Confirmed

    10

    Scinopharm Taiwan Ltd

    Taiwan
    arrow
    ISPE Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20942

    Submission : 2007-10-12

    Status : Active

    Type : II

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    PHYTON BIOTECH LLC Delta CA

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothPhyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

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    Flag Canada
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    Digital Content Digital Content

    Docetaxel

    Portfolio PDF

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    R1-CEP 2012-105 - Rev 01
    Valid
    Chemical
    2019-10-08
    2593
    Phyton Company Banner

    01

    PHYTON BIOTECH LLC Delta CA

    Canada
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    BioJapan
    Attending
    • fda
    • EDQM
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    Virtual BoothPhyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

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    Flag Canada
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    Digital Content Digital Content

    Docetaxel

    Certificate Number : R1-CEP 2012-105 - Rev 01

    Status : Valid

    Issue Date : 2019-10-08

    Type : Chemical

    Substance Number : 2593

    Phyton Company Banner

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    SANOFI WINTHROP INDUSTRIE Gentilly ...

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Docetaxel trihydrate

    Portfolio PDF

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    CEP 2009-343 - Rev 04
    Valid
    Chemical
    2024-03-28
    2449
    Sanofi Company Banner

    02

    SANOFI WINTHROP INDUSTRIE Gentilly ...

    France
    arrow
    BIO International Convention
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Docetaxel Trihydrate

    Certificate Number : CEP 2009-343 - Rev 04

    Status : Valid

    Issue Date : 2024-03-28

    Type : Chemical

    Substance Number : 2449

    Sanofi Company Banner

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    Fujian South Pharmaceutical Co., Lt...

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      Docetaxel

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      R0-CEP 2011-320 - Rev 00
      Withdrawn by Holder
      Chemical
      2013-01-30
      2016-09-05
      2593
      blank

      03

      Fujian South Pharmaceutical Co., Lt...

      China
      PEGS Boston Summit
      Not Confirmed
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      Fujian South Pharmaceutical Co., Lt...

      China
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      PEGS Boston Summit
      Not Confirmed
      • fda
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      Docetaxel

      Certificate Number : R0-CEP 2011-320 - Rev 00

      Status : Withdrawn by Holder

      Issue Date : 2013-01-30

      Type : Chemical

      Substance Number : 2593

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      HUBEI HAOSUN PHARMACEUTICAL CO., LT...

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      Docetaxel, Process II

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      R0-CEP 2021-302 - Rev 00
      Valid
      Chemical
      2022-01-07
      2593
      blank

      04

      HUBEI HAOSUN PHARMACEUTICAL CO., LT...

      China
      PEGS Boston Summit
      Not Confirmed
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      HUBEI HAOSUN PHARMACEUTICAL CO., LT...

      China
      arrow
      PEGS Boston Summit
      Not Confirmed
      • fda
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      • WHO-GMP
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      Docetaxel, Process II

      Certificate Number : R0-CEP 2021-302 - Rev 00

      Status : Valid

      Issue Date : 2022-01-07

      Type : Chemical

      Substance Number : 2593

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      INDENA S.P.A. Milano IT

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      • fda
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      Docetaxel

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      R1-CEP 2012-216 - Rev 01
      Valid
      Chemical
      2020-08-25
      2593
      blank

      05

      INDENA S.P.A. Milano IT

      Italy
      PEGS Boston Summit
      Not Confirmed
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      INDENA S.P.A. Milano IT

      Italy
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      PEGS Boston Summit
      Not Confirmed
      • fda
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      Docetaxel

      Certificate Number : R1-CEP 2012-216 - Rev 01

      Status : Valid

      Issue Date : 2020-08-25

      Type : Chemical

      Substance Number : 2593

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      INTAS PHARMACEUTICALS LIMITED North...

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      • fda
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      R0-CEP 2012-301 - Rev 00
      Withdrawn by Holder
      Chemical
      2013-09-10
      2018-06-27
      2593
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      06

      INTAS PHARMACEUTICALS LIMITED North...

      India
      PEGS Boston Summit
      Not Confirmed
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      INTAS PHARMACEUTICALS LIMITED North...

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      PEGS Boston Summit
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      Docetaxel

      Certificate Number : R0-CEP 2012-301 - Rev 00

      Status : Withdrawn by Holder

      Issue Date : 2013-09-10

      Type : Chemical

      Substance Number : 2593

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      POLYMED THERAPEUTICS, INC. Houston ...

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        R0-CEP 2013-074 - Rev 02
        Withdrawn by Holder
        Chemical
        2017-10-27
        2020-03-02
        2449
        blank

        07

        POLYMED THERAPEUTICS, INC. Houston ...

        U.S.A
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        Not Confirmed
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        POLYMED THERAPEUTICS, INC. Houston ...

        U.S.A
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        PEGS Boston Summit
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        Docetaxel Trihydrate

        Certificate Number : R0-CEP 2013-074 - Rev 02

        Status : Withdrawn by Holder

        Issue Date : 2017-10-27

        Type : Chemical

        Substance Number : 2449

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        POLYMED THERAPEUTICS, INC. Houston ...

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          R1-CEP 2012-029 - Rev 01
          Valid
          Chemical
          2019-03-25
          2593
          blank

          08

          POLYMED THERAPEUTICS, INC. Houston ...

          U.S.A
          PEGS Boston Summit
          Not Confirmed
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          POLYMED THERAPEUTICS, INC. Houston ...

          U.S.A
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          PEGS Boston Summit
          Not Confirmed
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          Docetaxel

          Certificate Number : R1-CEP 2012-029 - Rev 01

          Status : Valid

          Issue Date : 2019-03-25

          Type : Chemical

          Substance Number : 2593

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          SAMYANG BIOPHARMACEUTICALS CORPORAT...

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          R0-CEP 2012-240 - Rev 01
          Expired
          Chemical
          2014-06-26
          2019-05-02
          2449
          blank

          09

          SAMYANG BIOPHARMACEUTICALS CORPORAT...

          South Korea
          PEGS Boston Summit
          Not Confirmed
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          SAMYANG HOLDINGS CORPORATION Gyeong...

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            R1-CEP 2013-185 - Rev 01
            Valid
            Chemical
            2021-08-12
            2593
            blank

            10

            SAMYANG HOLDINGS CORPORATION Gyeong...

            South Korea
            PEGS Boston Summit
            Not Confirmed
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            SAMYANG HOLDINGS CORPORATION Gyeong...

            South Korea
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            Docetaxel

            Certificate Number : R1-CEP 2013-185 - Rev 01

            Status : Valid

            Issue Date : 2021-08-12

            Type : Chemical

            Substance Number : 2593

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            01

            Phyton Biotech LLC

            Canada
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            Virtual BoothPhyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

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            Docetaxel

            Registrant Name : Sampoong Pharmachem Co., Ltd.

            Registration Date : 2020-04-21

            Registration Number : 20200421-210-J-608

            Manufacturer Name : Phyton Biotech LLC

            Manufacturer Address : 1527 Cliveden Avenue, Delta, British Columbia, V3M6P7, Canada

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            02

            Fresenius Kabi AB Brunna

            Sweden
            ISPE Europe
            Not Confirmed
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            Fresenius Kabi AB Brunna

            Sweden
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            ISPE Europe
            Not Confirmed
            • fda
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            Docetaxel anhydride

            Registrant Name : Aging Life Science Co., Ltd.

            Registration Date : 2022-08-29

            Registration Number : 20220829-210-J-1352

            Manufacturer Name : Fresenius Kabi Oncology Limi...

            Manufacturer Address : D-35, Industrial Area, Kalyani, Nadia-741 235 West Bengal, India

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            03

            Intas Pharmaceuticals

            India
            ISPE Europe
            Not Confirmed
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            Intas Pharmaceuticals

            India
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            ISPE Europe
            Not Confirmed
            • fda
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            Docetaxel

            Registrant Name : Myungmoon Pharmaceutical Co., Ltd.

            Registration Date : 2021-01-13

            Registration Number : 20210113-210-J-821

            Manufacturer Name : Intas Pharmaceuticals Limite...

            Manufacturer Address : Plot No. 457 & 458, Village Matoda, Bavla road and Plot No. 191/218 P, Village Chacha...

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            Mac-Chem Products (India) Pvt.Ltd

            India
            ISPE Europe
            Not Confirmed
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            Mac-Chem Products (India) Pvt.Ltd

            India
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            Not Confirmed
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            Docetaxel hydrate

            Registrant Name : Masung LS Co., Ltd.

            Registration Date : 2020-11-06

            Registration Number : 20201106-210-J-765

            Manufacturer Name : Mac-Chem Products (India) Pv...

            Manufacturer Address : N-211/2/10, Tarapur, MIDC, Boisar, Dist. Palghar, 401506, India

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            Qilu Antibiotics Pharmaceutical Co....

            China
            ISPE Europe
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            Qilu Antibiotics Pharmaceutical Co....

            China
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            Docetaxel

            Registrant Name : Kangil Chemical Farm Co., Ltd.

            Registration Date : 2022-08-03

            Registration Number : 20220517-210-J-1300(1)

            Manufacturer Name : Qilu Pharmaceutical Co. Ltd

            Manufacturer Address : No. 23999 Gong Ye Bei Road, Jinan, Shandong Province, PRChina Post code: 250100

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            Qilu Antibiotics Pharmaceutical Co....

            China
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            Qilu Antibiotics Pharmaceutical Co....

            China
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            Docetaxel trihydrate

            Registrant Name : Hiple Co., Ltd.

            Registration Date : 2024-10-14

            Registration Number : 20200723-210-J-699(A)

            Manufacturer Name : Qilu Pharmaceutical Co., Ltd...

            Manufacturer Address : No. 23999 Gong Ye Bei Road, Jinan, Shandong Province, 250100, PR China

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            Qilu Antibiotics Pharmaceutical Co....

            China
            ISPE Europe
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            Qilu Antibiotics Pharmaceutical Co....

            China
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            Docetaxel anhydride

            Registrant Name : Eltek Pharmachem Co., Ltd.

            Registration Date : 2022-05-24

            Registration Number : 20220517-210-J-1300(A)

            Manufacturer Name : Qilu Pharmaceutical Co., Ltd...

            Manufacturer Address : No. 23999 Gong Ye Bei Road, Jinan, Shandong Province, 250100, PR China

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            Qilu Antibiotics Pharmaceutical Co....

            China
            ISPE Europe
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            Qilu Antibiotics Pharmaceutical Co....

            China
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            Docetaxel

            Registrant Name : Samyang Holdings Co., Ltd.

            Registration Date : 2022-05-17

            Registration Number : 20220517-210-J-1300

            Manufacturer Name : Qilu Pharmaceutical Co. Ltd

            Manufacturer Address : No. 23999 Gong Ye Bei Road, Jinan, Shandong Province, PRChina Post code: 250100

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            09

            Samyang Corporation

            South Korea
            ISPE Europe
            Not Confirmed
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            Samyang Corporation

            South Korea
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            ISPE Europe
            Not Confirmed
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            Docetaxel anhydride

            Registrant Name : Samyang Holdings Co., Ltd.

            Registration Date : 2021-03-31

            Registration Number : 20210331-210-J-916

            Manufacturer Name : Samyang Holdings Co., Ltd.

            Manufacturer Address : 79 Sinildong-ro, Daedeok-gu, Daejeon

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            10

            ScinoPharm Taiwan Ltd

            Taiwan
            ISPE Europe
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            ScinoPharm Taiwan Ltd

            Taiwan
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            ISPE Europe
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            Docetaxel trihydrate

            Registrant Name : Hiple Co., Ltd.

            Registration Date : 2022-05-24

            Registration Number : 20220524-210-J-1304

            Manufacturer Name : ScinoPharm Taiwan, Ltd.

            Manufacturer Address : No. 1, Nan-ke 8th Road, Shan-Hua, Tainan 741014, Taiwan

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            NDC API

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            01

            Phyton Biotech LLC

            Canada
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            BioJapan
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            Virtual BoothPhyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

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            DOCETAXEL ANHYDROUS

            NDC Package Code : 51446-0220

            Start Marketing Date : 2012-11-20

            End Marketing Date : 2025-12-31

            Dosage Form (Strength) : POWDER (1g/g)

            Marketing Category : BULK INGREDIENT

            Phyton Company Banner

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            02

            Hubei Haosun Pharmaceutical Co., Lt...

            China
            BioProcess International Europe
            Not Confirmed
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            Hubei Haosun Pharmaceutical Co., Lt...

            China
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            BioProcess International Europe
            Not Confirmed
            • fda
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            DOCETAXEL ANHYDROUS

            NDC Package Code : 14778-1212

            Start Marketing Date : 2011-10-10

            End Marketing Date : 2025-12-31

            Dosage Form (Strength) : POWDER (1g/g)

            Marketing Category : BULK INGREDIENT

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            03

            Jiangsu Hengrui Pharmaceuticals Co....

            China
            BioProcess International Europe
            Not Confirmed
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            Jiangsu Hengrui Pharmaceuticals Co....

            China
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            BioProcess International Europe
            Not Confirmed
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            DOCETAXEL

            NDC Package Code : 57884-0014

            Start Marketing Date : 2010-09-13

            End Marketing Date : 2025-12-31

            Dosage Form (Strength) : POWDER (1kg/kg)

            Marketing Category : BULK INGREDIENT

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            04

            MSN Laboratories Private Limited

            India
            BioProcess International Europe
            Not Confirmed
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            MSN Laboratories Private Limited

            India
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            BioProcess International Europe
            Not Confirmed
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            DOCETAXEL

            NDC Package Code : 54893-0008

            Start Marketing Date : 2011-10-13

            End Marketing Date : 2025-12-31

            Dosage Form (Strength) : POWDER (1kg/kg)

            Marketing Category : BULK INGREDIENT

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            05

            Qilu Pharmaceutical Co. Ltd.

            China
            BioProcess International Europe
            Not Confirmed
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            Qilu Pharmaceutical Co. Ltd.

            China
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            BioProcess International Europe
            Not Confirmed
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            DOCETAXEL

            NDC Package Code : 67184-0018

            Start Marketing Date : 2011-10-13

            End Marketing Date : 2025-12-31

            Dosage Form (Strength) : POWDER (1kg/kg)

            Marketing Category : BULK INGREDIENT

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            06

            Shandong Anxin Pharmaceutical Co., ...

            United Kingdom
            BioProcess International Europe
            Not Confirmed
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            Shandong Anxin Pharmaceutical Co., ...

            United Kingdom
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            BioProcess International Europe
            Not Confirmed
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            DOCETAXEL

            NDC Package Code : 35369-0022

            Start Marketing Date : 2025-02-26

            End Marketing Date : 2026-12-31

            Dosage Form (Strength) : POWDER (5kg/5kg)

            Marketing Category : BULK INGREDIENT

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            07

            ScinoPharm Taiwan Ltd.

            Taiwan
            BioProcess International Europe
            Not Confirmed
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            ScinoPharm Taiwan Ltd.

            Taiwan
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            BioProcess International Europe
            Not Confirmed
            • fda
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            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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            DOCETAXEL ANHYDROUS

            NDC Package Code : 65129-1298

            Start Marketing Date : 2016-01-24

            End Marketing Date : 2026-12-31

            Dosage Form (Strength) : POWDER (1kg/kg)

            Marketing Category : BULK INGREDIENT

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            08

            ScinoPharm Taiwan Ltd.

            Taiwan
            BioProcess International Europe
            Not Confirmed
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            ScinoPharm Taiwan Ltd.

            Taiwan
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            BioProcess International Europe
            Not Confirmed
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            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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            DOCETAXEL ANHYDROUS

            NDC Package Code : 65129-1141

            Start Marketing Date : 2001-08-24

            End Marketing Date : 2025-12-31

            Dosage Form (Strength) : POWDER (1kg/kg)

            Marketing Category : BULK INGREDIENT

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            09

            Sicor de Mexico S.A. de C.V

            Mexico
            BioProcess International Europe
            Not Confirmed
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            Sicor de Mexico S.A. de C.V

            Mexico
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            BioProcess International Europe
            Not Confirmed
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            DOCETAXEL ANHYDROUS

            NDC Package Code : 63592-0360

            Start Marketing Date : 2018-10-19

            End Marketing Date : 2025-12-31

            Dosage Form (Strength) : POWDER (100kg/100kg)

            Marketing Category : BULK INGREDIENT

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            10

            Yung Shin Pharmaceutical Ind. Co., ...

            Taiwan
            BioProcess International Europe
            Not Confirmed
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            Yung Shin Pharmaceutical Ind. Co., ...

            Taiwan
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            BioProcess International Europe
            Not Confirmed
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            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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            DOCETAXEL

            NDC Package Code : 63126-901

            Start Marketing Date : 2012-12-26

            End Marketing Date : 2025-12-31

            Dosage Form (Strength) : POWDER (1g/g)

            Marketing Category : BULK INGREDIENT

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            Listed Suppliers

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            01

            Phyton Biotech LLC

            Canada
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            BioJapan
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            Virtual BoothPhyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

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            Docetaxel

            About the Company : Phyton Biotech, a division of DFB Pharmaceuticals, was founded in 1990. Using its Plant Cell Fermentation (PCF) technology, Phyton Biotech is currently the world’s largest produc...

            Phyton Biotech, a division of DFB Pharmaceuticals, was founded in 1990. Using its Plant Cell Fermentation (PCF) technology, Phyton Biotech is currently the world’s largest producer of high-quality paclitaxel and docetaxel. It offers clients a full range of integrated contract product and process development and commercial manufacturing services across the entire development chain, from feasibility to commercial production, to the pharmaceutical, cosmetic, agricultural and food ingredient industries. Its facilities in Germany and Canada have been inspected by multiple regulatory agencies and comply with international GMP requirements.
            Phyton Company Banner

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            02

            Rochem International Inc

            U.S.A
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            CPhI WW Frankfurt
            Booth #12.0F117
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            Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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            Docetaxel

            About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

            Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
            Rochem

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            03

            Alchem International Private Ltd

            India
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            CPhI China
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            Virtual BoothAlchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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            Docetaxel

            About the Company : Alchem International, established in 1935, is a pioneer in phytochemicals, providing plant-derived active pharmaceutical ingredients to the pharmaceutical, cosmetic and nutraceutic...

            Alchem International, established in 1935, is a pioneer in phytochemicals, providing plant-derived active pharmaceutical ingredients to the pharmaceutical, cosmetic and nutraceutical industries. With over 75 years of experience, Alchem has established a global presence, selling its products in more than 35 countries. Alchem has three manufacturing sites spread across 62 acres in India and four international divisions with offices in India, Europe, Hong Kong and the US. Alchem has two divisions – Phytoceuticals and EpiQue – that provide healthcare and cosmetic products to the Indian market and employs over 1,000 people worldwide.
            Alchem

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            04

            LGM Pharma

            U.S.A
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            CPhI North America
            Booth #1147
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            Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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            Docetaxel

            About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

            LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
            LGM Pharma CB

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            05

            HRV Global Life Sciences

            India
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            CPhI North America
            Attending
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            Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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            Docetaxel

            About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

            HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
            HRV Global Life Sciences

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            06

            Tenatra Chemie

            India
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            CPhI China
            Attending
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            Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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            Docetaxel

            About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

            Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Chemie Private Limited (TCPL) was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India.
            Tenatra

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            07

            TAPI Technology & API Services

            Israel
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            TIDES USA
            Attending
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            Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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            Docetaxel

            About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

            Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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            08

            Jiwan Pharmaceutical Technology Co....

            China
            Bioequity Europe
            Not Confirmed
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            Jiwan Pharmaceutical Technology Co....

            China
            arrow
            Bioequity Europe
            Not Confirmed
            • fda
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            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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            Docetaxel Trihydrate

            About the Company : Located in beautiful Spring City-Jinan,Jiwan is a high-tech pharmaceutical company,specializing in R&D, technology transfer and technical consulting of biotechnology and pharmaceut...

            Located in beautiful Spring City-Jinan,Jiwan is a high-tech pharmaceutical company,specializing in R&D, technology transfer and technical consulting of biotechnology and pharmaceutical technology. Moreover, Jiwan has the right of dealing import and export business of APIs,intermediates and fine chemical goods. Jiwan has a group of high-level specialists from various fields of pharmaceutics and its related sciences who have rich experence and professional research talents and have been working together for more than 10 years.
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            09

            Sichuan Xieli Pharmaceutical

            China
            Bioequity Europe
            Not Confirmed
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            Sichuan Xieli Pharmaceutical

            China
            arrow
            Bioequity Europe
            Not Confirmed
            • fda
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            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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            Docetaxel

            About the Company : Founded in 1980, Sichuan Xieli Pharmaceutical Co., Ltd. operates with the guiding principle of "collaborating to build a healthy enterprise." The company specializes in the cultiva...

            Founded in 1980, Sichuan Xieli Pharmaceutical Co., Ltd. operates with the guiding principle of "collaborating to build a healthy enterprise." The company specializes in the cultivation of ecological medicinal materials, extraction of natural active ingredients from plants and animals, and the synthesis and R&D of their derivatives. Its core focus lies in producing high value-added products for export. The company’s diverse portfolio includes dozens of products such as rutin-based cardiovascular and cerebrovascular medications, plant flavonoid capillary drugs, plant-derived anti-tumor agents, animal and plant extracts, etc.
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            10

            Vinkem Labs Ltd

            India
            Bioequity Europe
            Not Confirmed
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            Vinkem Labs Ltd

            India
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            Bioequity Europe
            Not Confirmed
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            docetaxel trihydrate

            About the Company : VINKEM - One Stop Solution for complete range ofOncology In-house API's & Finished dosage injectables in liquid vials andlyophilized form.State of Art cGMP facility with DMF and ...

            VINKEM - One Stop Solution for complete range ofOncology In-house API's & Finished dosage injectables in liquid vials andlyophilized form.State of Art cGMP facility with DMF and ANDA support with2 to 100 ml BOSCH-Germany integrated wash-sterilising-Fill and seal line withRABS technology with IPC, 7.5 M3 Lyophilizer,& 100% SAL. Equipments & Instruments are SCADA 21-CFR Compliant with Siemen'sBio-Metric control and BMS.Offers excellent scope for investment / marketingtie-up / R&D /Contract Manufacturing.Products: Vinblastine, Vincristine,Vinorelbine, Vindesine,Paclitaxel, Docetaxel, Gemcitabine, Platin Complexes, Camptothecine Derivatives, etc.Soft gel dosage forms (Vinorelbine, Vinflunine and other products) nearing completion.
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LTD.","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"VENUS REMEDIES","customerCountry":"INDIA","quantity":"2.65","actualQuantity":"2650","unit":"GMS","unitRateFc":"28.5","totalValueFC":"76130.3","currency":"USD","unitRateINR":"2441","date":"07-Dec-2024","totalValueINR":"6468716.25","totalValueInUsd":"76130.3","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"7101446","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"317 XINLUO ROAD HIGH-TECH ZONE JINA N 250101 P.R.CHINA Jinan, , CHINA SDNF CHINA","customerAddress":"S.C.O.857, CABIN NO. 10, 2ND FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1735756200,"product":"(71265) DOCETAXEL ANHYDROUS USP (BATCH - 71265AA268)","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"SCINOPHARM TAIWAN LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"38000","totalValueFC":"113630.9","currency":"USD","unitRateINR":"3266100","date":"02-Jan-2025","totalValueINR":"9798300","totalValueInUsd":"113630.9","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29420090","bill_no":"7577448","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"No. 1, NanKe 8th Road, SHAN HUA TAINAN SDNF Taiwan","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740681000,"product":"(71265) DOCETAXEL ANHYDROUS USP","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"SCINOPHARM TAIWAN LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"38000","totalValueFC":"153373.7","currency":"USD","unitRateINR":"3334500","date":"28-Feb-2025","totalValueINR":"13338000","totalValueInUsd":"153373.7","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29420090","bill_no":"8609222","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"NO1, NAN KE 8TH ROAD SHAN HUA TAINAN 741014 SDNF Taiwan","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741804200,"product":"DOCETAXEL ANHYDROUS I.P. DOCETAXEL ANHYDROUS I.P.","address":"402,MAN EXCELLENZA,OPP GRASS HOPPER RESTAURANT","city":"MUMBAI","supplier":"SHENZHEN HANOFINE BIOTECHNOLOGY CO. - LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"PHARMACARE PREMIUM","customerCountry":"INDIA","quantity":"0.63","actualQuantity":"0.625","unit":"KGS","unitRateFc":"11000","totalValueFC":"6968.9","currency":"USD","unitRateINR":"965800","date":"13-Mar-2025","totalValueINR":"603625","totalValueInUsd":"6968.9","indian_port":"Bombay Air","hs_no":"29329990","bill_no":"8870388","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"RM 2412-2413 NO:5022 BINHE ROAD UNI TED , PLAZA A,FITIAN DISTRICT,SHENZ HEN,GUANGDO CHINA , , CHINA CHINA","customerAddress":"402,MAN EXCELLENZA,OPP GRASS HOPPER RESTAURANT"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742149800,"product":"DOCETAXEL ANHYDROUS IP\/USP\/PH. EUR. BN: 71265AA266\/71265","address":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ","city":"TAL- SANAND, DIST- AHMEDABAD","supplier":"SCINOPHARM TAIWAN LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"5.17","actualQuantity":"5.17","unit":"KGS","unitRateFc":"60732.1","totalValueFC":"318271","currency":"USD","unitRateINR":"5332275.8","date":"17-Mar-2025","totalValueINR":"27567866.05","totalValueInUsd":"318271","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29329990","bill_no":"8922423","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"No. 1, Nan-Ke-8th road SHAN HUA, TAINAN SDNF Taiwan","customerAddress":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744569000,"product":"DOCETAXEL IP DOCETAXEL IP","address":"646, LAXMI PLAZA,LAXMI INDL. EST.","city":"ANDHERI WEST MUMBAI","supplier":"SPG PHARMA COMPANY","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"KETAN PHARMA","customerCountry":"INDIA","quantity":"0.72","actualQuantity":"0.72","unit":"KGS","unitRateFc":"10000","totalValueFC":"7284","currency":"USD","unitRateINR":"866000","date":"14-Apr-2025","totalValueINR":"623520","totalValueInUsd":"7284","indian_port":"Bombay Air","hs_no":"29329990","bill_no":"9472741","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"RM307 3\/F LEMMI CENTRE 50 HOI YUEN ROAD KWUN TONG KOWLOON Kowloon, , H ONG KONG HONG KONG","customerAddress":"646, LAXMI PLAZA,LAXMI INDL. EST."}]
            17-May-2021
            14-Apr-2025
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            Drugs in Development

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            • Development Update
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            Orion and Bayer Expand Clinical Development Program for Darolutamide in Prostate Cancer

            Details:

            Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.


            Lead Product(s): Darolutamide,Docetaxel

            Therapeutic Area: Oncology Brand Name: Nubeqa

            Study Phase: Approved FDFProduct Type: HPAPI

            Sponsor: Bayer AG

            Deal Size: Inapplicable Upfront Cash: Inapplicable

            Deal Type: Inapplicable March 23, 2023

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            01

            Orion Corporation

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            Lead Product(s) : Darolutamide,Docetaxel

            Therapeutic Area : Oncology

            Highest Development Status : Approved FDF

            Partner/Sponsor/Collaborator : Bayer AG

            Deal Size : Inapplicable

            Deal Type : Inapplicable

            DEALS_DEV arrow-down

            Orion and Bayer Expand Clinical Development Program for Darolutamide in Prostate Cancer

            Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...

            Product Name : Nubeqa

            Product Type : HPAPI

            Upfront Cash : Inapplicable

            March 23, 2023

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            Data Compilation
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            Darolutamide Approved for Additional Prostate Cancer Indication in China

            Details:

            Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.


            Lead Product(s): Darolutamide,Docetaxel

            Therapeutic Area: Oncology Brand Name: Nubeqa

            Study Phase: Approved FDFProduct Type: HPAPI

            Sponsor: Inapplicable

            Deal Size: Inapplicable Upfront Cash: Inapplicable

            Deal Type: Inapplicable March 20, 2023

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            Orion Corporation

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            Lead Product(s) : Darolutamide,Docetaxel

            Therapeutic Area : Oncology

            Highest Development Status : Approved FDF

            Partner/Sponsor/Collaborator : Inapplicable

            Deal Size : Inapplicable

            Deal Type : Inapplicable

            DEALS_DEV arrow-down

            Darolutamide Approved for Additional Prostate Cancer Indication in China

            Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...

            Product Name : Nubeqa

            Product Type : HPAPI

            Upfront Cash : Inapplicable

            March 20, 2023

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            Darolutamide Receives Approval for Additional Prostate Cancer Indication in Japan

            Details:

            Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.


            Lead Product(s): Darolutamide,Docetaxel

            Therapeutic Area: Oncology Brand Name: Nubeqa

            Study Phase: Approved FDFProduct Type: HPAPI

            Sponsor: Bayer AG

            Deal Size: Inapplicable Upfront Cash: Inapplicable

            Deal Type: Inapplicable February 27, 2023

            Fermion Orion Company Banner

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            Orion Corporation

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            Lead Product(s) : Darolutamide,Docetaxel

            Therapeutic Area : Oncology

            Highest Development Status : Approved FDF

            Partner/Sponsor/Collaborator : Bayer AG

            Deal Size : Inapplicable

            Deal Type : Inapplicable

            DEALS_DEV arrow-down

            Darolutamide Receives Approval for Additional Prostate Cancer Indication in Japan

            Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...

            Product Name : Nubeqa

            Product Type : HPAPI

            Upfront Cash : Inapplicable

            February 27, 2023

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            Positive CHMP Opinion for Darolutamide in Combination with Docetaxel for The Treatment of Metastatic Hormone-Sensitive Prostate Cancer

            Details:

            Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.


            Lead Product(s): Darolutamide,Docetaxel

            Therapeutic Area: Oncology Brand Name: Nubeqa

            Study Phase: Approved FDFProduct Type: HPAPI

            Sponsor: Inapplicable

            Deal Size: Inapplicable Upfront Cash: Inapplicable

            Deal Type: Inapplicable January 27, 2023

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            Orion Corporation

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            Lead Product(s) : Darolutamide,Docetaxel

            Therapeutic Area : Oncology

            Highest Development Status : Approved FDF

            Partner/Sponsor/Collaborator : Inapplicable

            Deal Size : Inapplicable

            Deal Type : Inapplicable

            DEALS_DEV arrow-down

            Positive CHMP Opinion for Darolutamide in Combination with Docetaxel for The Treatment of Metastat...

            Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...

            Product Name : Nubeqa

            Product Type : HPAPI

            Upfront Cash : Inapplicable

            January 27, 2023

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            Darolutamide Receives EU Approval for Additional Indication in Prostate Cancer

            Details:

            Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.


            Lead Product(s): Darolutamide,Docetaxel

            Therapeutic Area: Oncology Brand Name: Nubeqa

            Study Phase: Approved FDFProduct Type: HPAPI

            Sponsor: Inapplicable

            Deal Size: Inapplicable Upfront Cash: Inapplicable

            Deal Type: Inapplicable January 03, 2023

            Fermion Orion Company Banner

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            Orion Corporation

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            Lead Product(s) : Darolutamide,Docetaxel

            Therapeutic Area : Oncology

            Highest Development Status : Approved FDF

            Partner/Sponsor/Collaborator : Inapplicable

            Deal Size : Inapplicable

            Deal Type : Inapplicable

            DEALS_DEV arrow-down

            Darolutamide Receives EU Approval for Additional Indication in Prostate Cancer

            Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...

            Product Name : Nubeqa

            Product Type : HPAPI

            Upfront Cash : Inapplicable

            January 03, 2023

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            The FDA Approves the Use of Darolutamide in Combination with Docetaxel as An Additional Indication in The Treatment of Metastatic Hormone-Sensitive Pros...

            Details:

            Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cancer.


            Lead Product(s): Darolutamide,Docetaxel

            Therapeutic Area: Oncology Brand Name: Nubeqa

            Study Phase: Approved FDFProduct Type: HPAPI

            Sponsor: Inapplicable

            Deal Size: Inapplicable Upfront Cash: Inapplicable

            Deal Type: Inapplicable August 08, 2022

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            Orion Corporation

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            Lead Product(s) : Darolutamide,Docetaxel

            Therapeutic Area : Oncology

            Highest Development Status : Approved FDF

            Partner/Sponsor/Collaborator : Inapplicable

            Deal Size : Inapplicable

            Deal Type : Inapplicable

            DEALS_DEV arrow-down

            The FDA Approves the Use of Darolutamide in Combination with Docetaxel as An Additional Indication...

            Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cance...

            Product Name : Nubeqa

            Product Type : HPAPI

            Upfront Cash : Inapplicable

            August 08, 2022

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            Orion Plans to Focus Research and Product Development - In The Future on Cancer and Pain

            Details:

            Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cancer.


            Lead Product(s): Darolutamide,Docetaxel

            Therapeutic Area: Oncology Brand Name: Nubeqa

            Study Phase: Approved FDFProduct Type: HPAPI

            Sponsor: Inapplicable

            Deal Size: Inapplicable Upfront Cash: Inapplicable

            Deal Type: Inapplicable March 24, 2022

            Fermion Orion Company Banner

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            Orion Corporation

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            Lead Product(s) : Darolutamide,Docetaxel

            Therapeutic Area : Oncology

            Highest Development Status : Approved FDF

            Partner/Sponsor/Collaborator : Inapplicable

            Deal Size : Inapplicable

            Deal Type : Inapplicable

            DEALS_DEV arrow-down

            Orion Plans to Focus Research and Product Development - In The Future on Cancer and Pain

            Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cance...

            Product Name : Nubeqa

            Product Type : HPAPI

            Upfront Cash : Inapplicable

            March 24, 2022

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            The US Food and Drug Administration (FDA) Accepts a New Supplemental Marketing Authorization Application for the Additional Indication for Darolutamide ...

            Details:

            The sNDA is based on positive results from pivotal Phase III ARASENS trial demonstrating a statistically significant improvement in overall survival for Nubeqa (darolutamide) plus androgen deprivation therapy and docetaxel in men with mHSPC compared to ADT plus docetaxel.


            Lead Product(s): Darolutamide,Docetaxel

            Therapeutic Area: Oncology Brand Name: Nubeqa

            Study Phase: Phase IIIProduct Type: HPAPI

            Sponsor: Bayer AG

            Deal Size: Inapplicable Upfront Cash: Inapplicable

            Deal Type: Inapplicable March 05, 2022

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            Orion Corporation

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            Lead Product(s) : Darolutamide,Docetaxel

            Therapeutic Area : Oncology

            Highest Development Status : Phase III

            Partner/Sponsor/Collaborator : Bayer AG

            Deal Size : Inapplicable

            Deal Type : Inapplicable

            DEALS_DEV arrow-down

            The US Food and Drug Administration (FDA) Accepts a New Supplemental Marketing Authorization Appli...

            Details : The sNDA is based on positive results from pivotal Phase III ARASENS trial demonstrating a statistically significant improvement in overall survival for Nubeqa (darolutamide) plus androgen deprivation therapy and docetaxel in men with mHSPC compared to A...

            Product Name : Nubeqa

            Product Type : HPAPI

            Upfront Cash : Inapplicable

            March 05, 2022

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            ARASENS Trial with Darolutamide in Combination with Docetaxel and Androgen Deprivation Therapy Meets Primary Endpoint of Significantly Increasing Overal...

            Details:

            The ARASENS trial, Nubeqa (darolutamide) in combination with docetaxel and androgen deprivation therapy significantly increased overall survival for patients with metastatic hormone-sensitive prostate cancer.


            Lead Product(s): Darolutamide,Docetaxel

            Therapeutic Area: Oncology Brand Name: Nubeqa

            Study Phase: Phase IIIProduct Type: HPAPI

            Sponsor: Bayer AG

            Deal Size: Inapplicable Upfront Cash: Inapplicable

            Deal Type: Inapplicable March 12, 2021

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            Orion Corporation

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            Lead Product(s) : Darolutamide,Docetaxel

            Therapeutic Area : Oncology

            Highest Development Status : Phase III

            Partner/Sponsor/Collaborator : Bayer AG

            Deal Size : Inapplicable

            Deal Type : Inapplicable

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            ARASENS Trial with Darolutamide in Combination with Docetaxel and Androgen Deprivation Therapy Mee...

            Details : The ARASENS trial, Nubeqa (darolutamide) in combination with docetaxel and androgen deprivation therapy significantly increased overall survival for patients with metastatic hormone-sensitive prostate cancer.

            Product Name : Nubeqa

            Product Type : HPAPI

            Upfront Cash : Inapplicable

            March 12, 2021

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            iOnctura Commences Randomized Phase I/II study in Non-Small Cell Lung Cancer

            Details:

            IOA-244 (roginolisib) is an orally dosed small molecule allosteric modulator of PI3Kδ. It is being evaluated for the treatment of non-small cell lung cancer.


            Lead Product(s): Roginolisib,Docetaxel,Dostarlimab

            Therapeutic Area: Oncology Brand Name: IOA-244

            Study Phase: Phase I/ Phase IIProduct Type: Other Small Molecule

            Sponsor: Inapplicable

            Deal Size: Inapplicable Upfront Cash: Inapplicable

            Deal Type: Inapplicable May 08, 2025

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            Ionctura

            Switzerland
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            Lead Product(s) : Roginolisib,Docetaxel,Dostarlimab

            Therapeutic Area : Oncology

            Highest Development Status : Phase I/ Phase II

            Partner/Sponsor/Collaborator : Inapplicable

            Deal Size : Inapplicable

            Deal Type : Inapplicable

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            iOnctura Commences Randomized Phase I/II study in Non-Small Cell Lung Cancer

            Details : IOA-244 (roginolisib) is an orally dosed small molecule allosteric modulator of PI3Kδ. It is being evaluated for the treatment of non-small cell lung cancer.

            Product Name : IOA-244

            Product Type : Other Small Molecule

            Upfront Cash : Inapplicable

            May 08, 2025

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            ABOUT THIS PAGE

            Looking for 114977-28-5 / Docetaxel API manufacturers, exporters & distributors?

            Docetaxel manufacturers, exporters & distributors 1

            37

            PharmaCompass offers a list of Docetaxel API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Docetaxel manufacturer or Docetaxel supplier for your needs.

            Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Docetaxel manufacturer or Docetaxel supplier.

            PharmaCompass also assists you with knowing the Docetaxel API Price utilized in the formulation of products. Docetaxel API Price is not always fixed or binding as the Docetaxel Price is obtained through a variety of data sources. The Docetaxel Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

            API | Excipient name

            Docetaxel

            Synonyms

            114977-28-5, Taxotere, Docetaxel anhydrous, Docetaxol, Rp-56976, Docetaxel winthrop

            Cas Number

            114977-28-5

            Unique Ingredient Identifier (UNII)

            699121PHCA

            About Docetaxel

            A semisynthetic analog of PACLITAXEL used in the treatment of locally advanced or metastatic BREAST NEOPLASMS and NON-SMALL CELL LUNG CANCER.

            Docetaxel Trihydrate Manufacturers

            A Docetaxel Trihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Docetaxel Trihydrate, including repackagers and relabelers. The FDA regulates Docetaxel Trihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Docetaxel Trihydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

            click here to find a list of Docetaxel Trihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

            Docetaxel Trihydrate Suppliers

            A Docetaxel Trihydrate supplier is an individual or a company that provides Docetaxel Trihydrate active pharmaceutical ingredient (API) or Docetaxel Trihydrate finished formulations upon request. The Docetaxel Trihydrate suppliers may include Docetaxel Trihydrate API manufacturers, exporters, distributors and traders.

            click here to find a list of Docetaxel Trihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

            Docetaxel Trihydrate USDMF

            A Docetaxel Trihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Docetaxel Trihydrate active pharmaceutical ingredient (API) in detail. Different forms of Docetaxel Trihydrate DMFs exist exist since differing nations have different regulations, such as Docetaxel Trihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

            A Docetaxel Trihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Docetaxel Trihydrate USDMF includes data on Docetaxel Trihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Docetaxel Trihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

            click here to find a list of Docetaxel Trihydrate suppliers with USDMF on PharmaCompass.

            Docetaxel Trihydrate JDMF

            The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

            The Docetaxel Trihydrate Drug Master File in Japan (Docetaxel Trihydrate JDMF) empowers Docetaxel Trihydrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

            PMDA reviews the Docetaxel Trihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Docetaxel Trihydrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

            click here to find a list of Docetaxel Trihydrate suppliers with JDMF on PharmaCompass.

            Docetaxel Trihydrate KDMF

            In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

            Pharmaceutical companies submit a Docetaxel Trihydrate Drug Master File in Korea (Docetaxel Trihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Docetaxel Trihydrate. The MFDS reviews the Docetaxel Trihydrate KDMF as part of the drug registration process and uses the information provided in the Docetaxel Trihydrate KDMF to evaluate the safety and efficacy of the drug.

            After submitting a Docetaxel Trihydrate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Docetaxel Trihydrate API can apply through the Korea Drug Master File (KDMF).

            click here to find a list of Docetaxel Trihydrate suppliers with KDMF on PharmaCompass.

            Docetaxel Trihydrate CEP

            A Docetaxel Trihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Docetaxel Trihydrate Certificate of Suitability (COS). The purpose of a Docetaxel Trihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Docetaxel Trihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Docetaxel Trihydrate to their clients by showing that a Docetaxel Trihydrate CEP has been issued for it. The manufacturer submits a Docetaxel Trihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Docetaxel Trihydrate CEP holder for the record. Additionally, the data presented in the Docetaxel Trihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Docetaxel Trihydrate DMF.

            A Docetaxel Trihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Docetaxel Trihydrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

            click here to find a list of Docetaxel Trihydrate suppliers with CEP (COS) on PharmaCompass.

            Docetaxel Trihydrate WC

            A Docetaxel Trihydrate written confirmation (Docetaxel Trihydrate WC) is an official document issued by a regulatory agency to a Docetaxel Trihydrate manufacturer, verifying that the manufacturing facility of a Docetaxel Trihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Docetaxel Trihydrate APIs or Docetaxel Trihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Docetaxel Trihydrate WC (written confirmation) as part of the regulatory process.

            click here to find a list of Docetaxel Trihydrate suppliers with Written Confirmation (WC) on PharmaCompass.

            Docetaxel Trihydrate NDC

            National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Docetaxel Trihydrate as an active pharmaceutical ingredient (API).

            Finished drug products

            The FDA updates the NDC directory daily. The NDC numbers for Docetaxel Trihydrate API and other APIs are published in this directory by the FDA.

            Unfinished drugs

            The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

            Pharmaceutical companies that manufacture Docetaxel Trihydrate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

            Compounded drug products

            The NDC directory also contains data on finished compounded human drug products that contain Docetaxel Trihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Docetaxel Trihydrate NDC to their finished compounded human drug products, they may choose to do so.

            click here to find a list of Docetaxel Trihydrate suppliers with NDC on PharmaCompass.

            Docetaxel Trihydrate GMP

            Docetaxel Trihydrate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

            GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

            PharmaCompass offers a list of Docetaxel Trihydrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Docetaxel Trihydrate GMP manufacturer or Docetaxel Trihydrate GMP API supplier for your needs.

            Docetaxel Trihydrate CoA

            A Docetaxel Trihydrate CoA (Certificate of Analysis) is a formal document that attests to Docetaxel Trihydrate's compliance with Docetaxel Trihydrate specifications and serves as a tool for batch-level quality control.

            Docetaxel Trihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Docetaxel Trihydrate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

            Docetaxel Trihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Docetaxel Trihydrate EP), Docetaxel Trihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Docetaxel Trihydrate USP).

            Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
            For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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