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    Chemistry

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    Also known as: 120511-73-1, Arimidex, Anastrazole, Anastrozol, Zd1033, 2,2'-(5-((1h-1,2,4-triazol-1-yl)methyl)-1,3-phenylene)bis(2-methylpropanenitrile)
    Molecular Formula
    C17H19N5
    Molecular Weight
    293.4  g/mol
    InChI Key
    YBBLVLTVTVSKRW-UHFFFAOYSA-N
    FDA UNII
    2Z07MYW1AZ
    Anastrozole
    A nitrile and triazole derivative that acts as a selective nonsteroidal aromatase inhibitor. It is used in the treatment of ESTROGEN NUCLEAR RECEPTOR-positive breast cancer in postmenopausal women.
    Anastrozole is an Aromatase Inhibitor. The mechanism of action of anastrozole is as an Aromatase Inhibitor.
    1 2D Structure

    Anastrozole

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[3-(2-cyanopropan-2-yl)-5-(1,2,4-triazol-1-ylmethyl)phenyl]-2-methylpropanenitrile
    2.1.2 InChI
    InChI=1S/C17H19N5/c1-16(2,9-18)14-5-13(8-22-12-20-11-21-22)6-15(7-14)17(3,4)10-19/h5-7,11-12H,8H2,1-4H3
    2.1.3 InChI Key
    YBBLVLTVTVSKRW-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(C)(C#N)C1=CC(=CC(=C1)CN2C=NC=N2)C(C)(C)C#N
    2.2 Other Identifiers
    2.2.1 UNII
    2Z07MYW1AZ
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2,2'-(5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-phenylene)bis(2-methylpropionitrile)

    2. Anastrazole

    3. Arimidex

    4. Ici D1033

    5. Zd 1033

    6. Zd-1033

    7. Zd1033

    8. Zeneca Zd 1033

    2.3.2 Depositor-Supplied Synonyms

    1. 120511-73-1

    2. Arimidex

    3. Anastrazole

    4. Anastrozol

    5. Zd1033

    6. 2,2'-(5-((1h-1,2,4-triazol-1-yl)methyl)-1,3-phenylene)bis(2-methylpropanenitrile)

    7. Ici D1033

    8. Zd-1033

    9. Ici-d1033

    10. 2-[3-(2-cyanopropan-2-yl)-5-(1,2,4-triazol-1-ylmethyl)phenyl]-2-methylpropanenitrile

    11. Alpha,alpha,alpha',alpha'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-m-benzenediacetonitrile

    12. Nsc-719344

    13. Nsc-759855

    14. 2z07myw1az

    15. Chembl1399

    16. 2,2'-[5-(1h-1,2,4-triazol-1-ylmethyl)benzene-1,3-diyl]bis(2-methylpropanenitrile)

    17. Chebi:2704

    18. Rvg-106400

    19. Nsc719344

    20. Ncgc00164619-01

    21. Asiolex

    22. Dsstox_cid_2607

    23. 2-[3-(1-cyano-1-methylethyl)-5-(1h-1,2,4-triazol-1-ylmethyl)phenyl]-2-methylpropanenitrile

    24. Dsstox_rid_76656

    25. Dsstox_gsid_22607

    26. Alpha1,alpha1,alpha3,alpha3-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-benzenediacetonitrile

    27. Zd 1033

    28. Arimidex (tn)

    29. Smr000466301

    30. Cas-120511-73-1

    31. Hsdb 7462

    32. Ici-d 1033

    33. Sr-01000759390

    34. Unii-2z07myw1az

    35. Ccris 9352

    36. Anastrozole [usan:usp:inn:ban]

    37. Anastrozole- Bio-x

    38. Arimidex (astrazeneca)

    39. Anastrozole [mi]

    40. Anastrozole [inn]

    41. Anastrozole [jan]

    42. Anastrozole [hsdb]

    43. Anastrozole [usan]

    44. Schembl9726

    45. Anastrozole [mart.]

    46. Anastrozole [usp-rs]

    47. Anastrozole [who-dd]

    48. Zinc941

    49. 1,3-benzenediacetonitrile, Alpha,alpha,alpha',alpha'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-

    50. Mls000759396

    51. Mls001424217

    52. Mls006011961

    53. Anastrozole (jan/usp/inn)

    54. Gtpl5137

    55. Dtxsid9022607

    56. Bdbm10015

    57. Anastrozole [orange Book]

    58. Anastrozole [ep Monograph]

    59. Anastrozole [usp Impurity]

    60. Bcpp000401

    61. Hms2052m11

    62. Hms2089n10

    63. Hms2235m06

    64. Hms3369k05

    65. Hms3394m11

    66. Hms3654i18

    67. Hms3715b05

    68. Hms3742o21

    69. Hms3866k03

    70. Pharmakon1600-01502278

    71. Anastrozole [usp Monograph]

    72. Act03222

    73. Amy42020

    74. Bcp02090

    75. Tox21_112238

    76. Tox21_303568

    77. Mfcd00866298

    78. Nsc759855

    79. S1188

    80. Stl451008

    81. Akos015894980

    82. Tox21_112238_1

    83. Ac-4234

    84. Bcp9000301

    85. Ccg-101109

    86. Cs-0716

    87. Db01217

    88. Ks-5052

    89. Nc00359

    90. Nsc 719344

    91. Nsc 759855

    92. Sb17304

    93. 2,2'-[5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-phenylene]bis(2-methylpropanenitrile)

    94. Ncgc00164619-02

    95. Ncgc00164619-04

    96. Ncgc00257356-01

    97. Bt164176

    98. Hy-14274

    99. Sw197739-4

    100. 11a731

    101. C08159

    102. D00960

    103. Ab00639929-06

    104. Ab00639929-08

    105. Ab00639929-09

    106. Ab00639929-10

    107. Ab00639929_11

    108. Ab00639929_13

    109. A804526

    110. Q419143

    111. Sr-01000759390-4

    112. Sr-01000759390-5

    113. Z1522566626

    114. 3-amino-3-(4-diethylamino-2-hydroxy-phenyl)-propionicacid

    115. 1,.alpha.,alpha.,alpha.',.alpha.'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-

    116. 2,2'-[5-(1h-1,2,4-triazol-1-yl-methyl)-1,3-phenylene]-di(2-methyl Propionitrile)

    117. 2,2'-[5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-phenylene]di(2-methylpropiononitrile)

    118. 2,2'-[5-(1h-1,2,4-triazole-1-yl-methyl)-1,3-phenylene]di(2-methyl Propionitrile)

    119. 2-[3-(2-cyano-2-propyl)-5-(1,2,4-triazol-1-ylmethyl)phenyl]-2-methylpropiononitrile

    120. 2-[3-(2-cyanopropan-2-yl)-5-(1,2,4-triazol-1-ylmethyl)phenyl]-2-methyl-propanenitrile

    121. .alpha.,.alpha.',.alpha.'-tetramethyl-5(1h-1,2,4-triazol-1-ylmethyl)-m-benzenediacetonitrile

    122. .alpha.,.alpha.,.alpha.',.alpha.'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-m-benzenediacetonitrile

    123. 1,3-benzenediacetonitrile,.alpha.,.alpha.,.alpha.',.alpha.'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-

    124. 2-[3-(1-cyano-1-methylethyl)-5-[(1h-1,2,4-triazol-1-yl)methyl]phenyl]-2-methylpropanenitrile

    125. Alpha,alpha,alpha',alpha'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-benzenediacetonitrile

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 293.4 g/mol
    Molecular Formula C17H19N5
    XLogP32.1
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count4
    Exact Mass293.16404563 g/mol
    Monoisotopic Mass293.16404563 g/mol
    Topological Polar Surface Area78.3 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity456
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    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 4  
    Drug NameAnastrozole
    PubMed HealthAnastrozole (By mouth)
    Drug ClassesAntineoplastic Agent, Endocrine-Metabolic Agent
    Drug LabelAnastrozole tablets for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formul
    Active IngredientAnastrozole
    Dosage FormTablet
    RouteOral
    Strength1mg
    Market StatusPrescription
    CompanySantos Biotech; Teva Pharms; Fresenius Kabi Oncol; Apotex; Accord Hlthcare; Sun Pharm Inds; Natco Pharma; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Three Rivers Pharms; Mylan; Roxane

    2 of 4  
    Drug NameArimidex
    PubMed HealthAnastrozole (By mouth)
    Drug ClassesAntineoplastic Agent, Endocrine-Metabolic Agent
    Drug LabelARIMIDEX (anastrozole) tablets for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molec
    Active IngredientAnastrozole
    Dosage FormTablet
    Routeoral; Oral
    Strength1mg
    Market StatusPrescription
    CompanyAstrazeneca

    3 of 4  
    Drug NameAnastrozole
    PubMed HealthAnastrozole (By mouth)
    Drug ClassesAntineoplastic Agent, Endocrine-Metabolic Agent
    Drug LabelAnastrozole tablets for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formul
    Active IngredientAnastrozole
    Dosage FormTablet
    RouteOral
    Strength1mg
    Market StatusPrescription
    CompanySantos Biotech; Teva Pharms; Fresenius Kabi Oncol; Apotex; Accord Hlthcare; Sun Pharm Inds; Natco Pharma; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Three Rivers Pharms; Mylan; Roxane

    4 of 4  
    Drug NameArimidex
    PubMed HealthAnastrozole (By mouth)
    Drug ClassesAntineoplastic Agent, Endocrine-Metabolic Agent
    Drug LabelARIMIDEX (anastrozole) tablets for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molec
    Active IngredientAnastrozole
    Dosage FormTablet
    Routeoral; Oral
    Strength1mg
    Market StatusPrescription
    CompanyAstrazeneca

    4.2 Therapeutic Uses

    Antineoplastic

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 105

    Anastrozole is indicated for the first-line treatment of postmenopausal woman with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. It is also indicated for treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. /Included in US product label/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 151

    Anastrozole is an option for the neoadjuvant treatment of hormone receptorpositive, locally advanced breast cancer in postmenopausal women. Two phase 2, randomized, double-blind clinical trials found anastrozole to be at least as effective as tamoxifen in response rates and rates of improved surgery. A phase 2, unpublished abstract reported no differences between neoadjuvant anastrozole and chemotherapy (doxorubicin and paclitaxel) in response rates, number of patients qualifying for breast-conserving surgery, and 3-year disease-free survival. An international expert panel recommends neoadjuvant endocrine therapy in postmenopausal women who would benefit from preoperative chemotherapy but are ineligible to receive it. Anastrozole was well-tolerated. /Not included in US product label/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 151

    Anastrozole is not recommended for use in premenopausal women. Safety and efficacy have not been established. /Included in US product label/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 151

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

    4.3 Drug Warning

    Among patients receiving adjuvant therapy, venous thromboembolic events occurred less frequently in patients receiving anastrozole than in those receiving tamoxifen (2 versus 4%); this included deep venous thrombosis (1 versus 2%). Ischemic cerebrovascular events also occurred less frequently in patients receiving anastrozole compared with those receiving tamoxifen (1 versus 2%). Ischemic cardiovascular disease was reported in 3% of such patients receiving anastrozole. Although angina pectoris was reported more frequently in patients receiving adjuvant therapy with anastrozole than in those receiving tamoxifen (about 2 versus 1%), the incidence of myocardial infarction was similar (0.8%).

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 927

    Among patients receiving anastrozole as first-line therapy, thromboembolic disease was reported in 18 patients (4%), with 5 patients experiencing venous thrombosis (including pulmonary embolus, thrombophlebitis, and retinal vein thrombosis) and 13 patients experiencing coronary and/or cerebral thrombosis (including myocardial infarction, myocardial ischemia, angina pectoris, cerebrovascular accident, cerebral ischemia, and cerebral infarct). Despite its lack of estrogenic activity, there was no evidence of an increased incidence of myocardial infarction in patients receiving anastrozole compared with those receiving tamoxifen.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 927

    Among patients receiving anastrozole as second-line therapy, thromboembolic disease was reported in 3%, and thrombophlebitis occurred in 2-5%.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 927

    Among patients receiving adjuvant therapy, hot flushes (flashes) occurred less frequently in patients receiving anastrozole than in those receiving tamoxifen (35 versus 40%). Among patients receiving anastrozole as first-line or second-line therapy, hot flushes occurred in 26 or 13%, respectively.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 927

    For more Drug Warnings (Complete) data for ANASTROZOLE (35 total), please visit the HSDB record page.

    4.4 Drug Indication

    Anastrozole is indicated as adjunct therapy in the treatment of hormone receptor-positive early breast cancer in postmenopausal women, and as a first-line treatment for hormone receptor-positive (or hormone receptor-unknown) locally advanced or metastatic breast cancer in postmenopausal women. It may also be used in the treatment of advanced breast cancer in postmenopausal women who experience disease progression despite treatment with [tamoxifen].

    Gynaecomastia, McCune-Albright syndrome, Short stature due to Growth Hormone deficiency, Testotoxicosis

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Anastrozole prevents the conversion of adrenal androgens (e.g. [testosterone]) to estrogen in peripheral and tumour tissues. As the growth of many breast cancers is stimulated and/or maintained by the presence of estrogen, anastrozole helps to treat these cancers by decreasing the levels of circulating estrogens. Anastrozole has a relatively long duration of action allowing for once daily dosing - serum estradiol is reduced by approximately 70% within 24 hours of beginning therapy with 1mg once daily, and levels remain suppressed for up to 6 days following cessation of therapy. The incidence of ischemic cardiovascular events was increased during anastrozole therapy and patients with pre-existing ischemic heart disease should consider the risks and benefits of anastrozole before beginning therapy. Anastrozole has also been reported to decrease spine and hip bone mineral density (BMD), so consideration should be given to monitoring of BMD in patients receiving long-term therapy.

    5.2 MeSH Pharmacological Classification

    Antineoplastic Agents, Hormonal

    Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079) (See all compounds classified as Antineoplastic Agents, Hormonal.)

    Aromatase Inhibitors

    Compounds that inhibit AROMATASE in order to reduce production of estrogenic steroid hormones. (See all compounds classified as Aromatase Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    ANASTROZOLE
    5.3.2 FDA UNII
    2Z07MYW1AZ
    5.3.3 Pharmacological Classes
    Aromatase Inhibitors [MoA]; Aromatase Inhibitor [EPC]
    5.4 ATC Code

    L02BG03

    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

    L02 - Endocrine therapy

    L02B - Hormone antagonists and related agents

    L02BG - Aromatase inhibitors

    L02BG03 - Anastrozole

    5.5 Absorption, Distribution and Excretion

    Absorption

    Anastrozole is rapidly absorbed and Tmax is typically reached within 2 hours of dosing under fasted conditions. Coadministration with food reduces the rate but not the overall extent of absorption - mean Cmax decreased by 16% and the median Tmax was extended to 5 hours when anastrozole was administered 30 minutes after ingestion of food, though this relatively minor alteration in absorption kinetics is not expected to result in clinically significant effects.

    Route of Elimination

    Hepatic metabolism accounts for approximately 85% of anastrozole elimination. Approximately 10% of the administered dosage is eliminated unchanged in the urine.

    Volume of Distribution

    The volume of distribution of anastrozole into brain tissue in mice is 3.19 mL/g. Distribution into the CNS is limited due to the activity of P-gp efflux pumps at the blood brain barrier, of which anastrozole is a substrate.

    Clearance

    Anastrozole's clearance is mainly via hepatic metabolism and can therefore be altered in patients with hepatic impairment - patients with stable hepatic cirrhosis exhibit an apparent oral clearance approximately 30% lower compared with patients with normal liver function. Conversely, renal impairment has a negligible effect on total drug clearance as the renal route is a relatively minor clearance pathway for anastrozole. In volunteers with severe renal impairment, renal clearance was reduced by 50% while total clearance was only reduced by approximately 10%.

    Anastrozole is well absorbed into systemic circulation following oral administration. Plasma concentrations approach steady-state at about 7 days of once-daily dosing, and steady-state concentrations are approximately 3-4 times higher than concentrations achieved after a single dose of the drug. Food does not affect the extent of oral absorption of anastrozole.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 930

    Within the therapeutic plasma concentration range, anastrozole is 40% bound to plasma proteins.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 930

    Steady-state minimum plasma concentrations averaged 25.7 and 30.4 ng/mL, respectively, in white and Japanese postmenopausal women receiving anastrozole 1 mg daily for 16 days; serum estradiol and estrone sulfate concentrations were similar between the groups.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 930

    It is not known whether anastrozole is distributed into milk in humans.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 930

    For more Absorption, Distribution and Excretion (Complete) data for ANASTROZOLE (10 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Anastrozole is primarily metabolized in the liver via oxidation and glucuronidation to a number of inactive metabolites, including hydroxyanastrozole (both free and glucuronidated) and anastrozole glucuronide. Oxidation to hydroxyanastrozole is catalyzed predominantly by CYP3A4 (as well as CYP3A5 and CYP2C8, to a lesser extent) and the direct glucuronidation of anastrozole appears to be catalyzed mainly by UGT1A4. Anastrozole may also undergo N-dealkylation to form triazole and 3,5-Bis-(2-methylpropiononitrile)-benzoic acid. Labels for anastrozole state the main metabolite found in plasma following administration is triazole, but a recent pharmacokinetic study was unable to detect any products of N-dealkylation _in vitro_.

    Anastrozole is extensively metabolized in the liver. Metabolism of anastrozole occurs via N-dealkylation, hydroxylation, and glucuronidation. Three metabolites of anastrozole have been identified in human plasma and urine: triazole, a glucuronide conjugate of anastrozole, and a glucuronide conjugate of hydroxyanastrozole. Triazole, the major circulating metabolite of anastrozole, lacks pharmacologic activity, and the aromatase inhibiting activity of anastrozole results principally from the parent drug. In addition, there are several minor metabolites of anastrozole, accounting for less than 5% of an administered dose, which have not been identified.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 929

    5.7 Biological Half-Life

    The elimination half-life of anastrozole is approximately 50 hours.

    Following oral administration of anastrozole in postmenopausal women, a mean terminal elimination half-life of approximately 50 hours has been reported.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 930

    5.8 Mechanism of Action

    Anastrazole exerts its anti-estrogenic effects via selective and competitive inhibition of the aromatase enzyme found predominantly in the adrenal glands, liver, and fatty tissues. Many breast cancers are hormone receptor-positive, meaning their growth is stimulated and/or maintained by the presence of hormones such as estrogen or progesterone. In postmenopausal women, estrogen is primarily derived from the conversion of adrenally-produced androgens into estrogens by the aromatase enzyme - by competitively inhibiting the biosynthesis of estrogen at these enzymes, anastrozole effectively suppresses circulating estrogen levels and, subsequently, the growth of hormone receptor-positive tumours.

    Anastrozole is a nonsteroidal aromatase inhibitor that interferes with estradiol production in peripheral tissues. Adrenally generated androstenedione, the chief source of circulating estrogen in postmenopausal women, is converted by aromatase to estrone, which is further converted to estradiol. Growth of many breast cancer tumors containing estrogen receptors and aromatase can be promoted by estrogen.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 151

    Anastrozole is a potent and selective non-steroidal aromatase inhibitor. It significantly lowers serum estradiol concentrations and has no detectable effect on formation of adrenal corticosteroids or aldosterone.

    Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 666

    Because estrogen acts as a growth factor for hormone-dependent breast cancer cells, anastrozole-induced reduction of serum and tumor concentrations of estrogen inhibits tumor growth and delays disease progression. Anastrozole selectively inhibits the conversion of androgens to estrogens. In postmenopausal women, ovarian secretion of estrogen declines and conversion of adrenal androgens (mainly androstenedione and testosterone) to estrone and estradiol in peripheral tissues (adipose, muscle, and liver), catalyzed by the aromatase enzyme, is the principal source of estrogens. Anastrozole inhibits the aromatase enzyme by competitively binding to the heme of the cytochrome P-450 unit of the enzyme; suppression of estrogen biosynthesis in all tissues reduces serum concentrations of circulating estrogens, including estrone, estradiol, and estrone sulfate. Anastrozole selectively inhibits synthesis of estrogens and does not affect synthesis of adrenal corticosteroid, aldosterone, or thyroid hormone. In animals, anastrozole has not been shown to possess direct progestogenic, androgenic, or estrogenic activity, but alterations in the circulating concentrations of progesterone, androgens, and estrogens have been observed.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 929

    API SUPPLIERS

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    01

    Suanfarma

    Spain

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    TAPI Technology & API Services

    Israel

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    Sun Pharmaceutical Industries Limi...

    India

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    Sun Pharmaceutical Industries Limi...

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-05-11

    Pay. Date : 2018-04-03

    DMF Number : 21901

    Submission : 2008-09-27

    Status : Active

    Type : II

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    Date of Issue : 2022-06-08

    Valid Till : 2025-07-25

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    NDC Package Code : 62756-428

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    China

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    Zhejiang Hisun Pharmaceutical

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-25

    Pay. Date : 2012-11-15

    DMF Number : 25897

    Submission : 2012-03-31

    Status : Active

    Type : II

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    NDC Package Code : 58623-0041

    Start Marketing Date : 2019-09-05

    End Marketing Date : 2025-12-31

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    Teva Pharmaceutical Industries

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    Submission : 2005-12-16

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    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2021-11-25

    Registration Number : 20211125-209-J-1160

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    Fareva

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-04-21

    Pay. Date : 2015-08-10

    DMF Number : 20338

    Submission : 2007-03-09

    Status : Active

    Type : II

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    Certificate Number : CEP 2024-160 - Rev 00

    Issue Date : 2024-08-30

    Type : Chemical

    Substance Number : 2406

    Status : Valid

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    Registration Number : 222MF10240

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    NDC Package Code : 46014-1160

    Start Marketing Date : 2021-05-12

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    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2022-10-21

    Registration Number : 20221021-209-J-1387

    Manufacturer Name : Excella GmbH & Co. KG

    Manufacturer Address : Nurnberger Strasse 12, 90537 Feucht, Germany

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    DMF Review : N/A

    Rev. Date :

    Pay. Date :

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    Submission : 2005-12-13

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    Germany

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    SYNTHON Chemicals GmbH & Co. KG

    Germany

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    GDUFA

    DMF Review : N/A

    Rev. Date :

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    DMF Number : 19211

    Submission : 2006-02-27

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    Tai Heng Industry Co., Ltd

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    GDUFA

    DMF Review : N/A

    Rev. Date :

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    DMF Number : 19496

    Submission : 2006-04-30

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    USDMF

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    Alcami Wisconsin Corp

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    Alcami Wisconsin Corp

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    Cipla Ltd

    India

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    Cipla Ltd

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    Excella Gmbh And Co Kg

    Luxembourg

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    Excella Gmbh And Co Kg

    Luxembourg
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    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-04-21

    Pay. Date : 2015-08-10

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    Taiwan
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    GDUFA

    DMF Review : N/A

    Rev. Date :

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    DMF Number : 20282

    Submission : 2007-02-15

    Status : Active

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    Natco Pharma Ltd

    India

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    Natco Pharma Ltd

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

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    Submission : 2006-08-11

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    Scinopharm Taiwan Ltd

    Taiwan

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    Scinopharm Taiwan Ltd

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-07-31

    Pay. Date : 2013-07-18

    DMF Number : 18335

    Submission : 2005-05-06

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    Synthon Bv

    Germany

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    Synthon Bv

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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"ANASTROZOLE","year":"2021","qtr":"Q1","strtotime":1612722600,"product":"ANASTROZOLE PH.EUR (GROUP:A SRL NO:1538","address":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"MALTA","customer":"PHARMACARE PREMIUM","customerCountry":"MALTA","quantity":"2.50","actualQuantity":"2.5","unit":"KGS","unitRateFc":"8845.8","totalValueFC":"21884.6","currency":"USD","unitRateINR":637337.59999999998,"date":"08-Feb-2021","totalValueINR":"1593344","totalValueInUsd":"21884.6","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"8497515","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"ANASTROZOLE","year":"2021","qtr":"Q1","strtotime":1612895400,"product":"ANASTROZOLE PH.EUR BATCH NOS: AL20100025","address":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"ONKO ILAC SAN.VE ","customerCountry":"TURKEY","quantity":"1.25","actualQuantity":"1.25","unit":"KGS","unitRateFc":"7741.2","totalValueFC":"9575.9","currency":"USD","unitRateINR":557754.34400000004,"date":"10-Feb-2021","totalValueINR":"697192.93","totalValueInUsd":"9575.9","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"8539692","productDescription":"API","marketType":"","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"ANASTROZOLE","year":"2021","qtr":"Q2","strtotime":1618943400,"product":"ANASTROZOLE PH.EUR (GROUP:A","address":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"MAPBIOPHARMA S.L","customerCountry":"SPAIN","quantity":"2.90","actualQuantity":"2.9","unit":"KGS","unitRateFc":"12347.4","totalValueFC":"34653.5","currency":"USD","unitRateINR":889627.75517241389,"date":"21-Apr-2021","totalValueINR":"2579920.49","totalValueInUsd":"34653.5","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"1251005","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"ANASTROZOLE","year":"2021","qtr":"Q2","strtotime":1619375400,"product":"ANASTROZOLE USP 42 BATCH NOS:AL20040019","address":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"HIKMA PHARMACEUTICALS","customerCountry":"EGYPT","quantity":"0.70","actualQuantity":"0.7","unit":"KGS","unitRateFc":"6675.1","totalValueFC":"4522","currency":"USD","unitRateINR":480939.88571428572,"date":"26-Apr-2021","totalValueINR":"336657.92","totalValueInUsd":"4522","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"1363698","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"ANASTROZOLE","year":"2021","qtr":"Q2","strtotime":1619634600,"product":"ANASTROZOLE","address":"304,?TOWN?CENTRE,?ANDHERI?KURLAROAD,?ANDHERI?(EAST),","city":"MUMBAI?\/?MAHARASHTRA","supplier":"MAC-CHEM PRODUCTS (INDIA) PVT.LTD","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"ARGENTINA","quantity":"0.40","actualQuantity":"0.4","unit":"KGS","unitRateFc":"11000","totalValueFC":"4378.8","currency":"USD","unitRateINR":815000,"date":"29-Apr-2021","totalValueINR":"326000","totalValueInUsd":"4378.8","indian_port":"BOMBAY AIR","hs_no":"29269000","bill_no":"1454203","productDescription":"API","marketType":"","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"304,?TOWN?CENTRE,?ANDHERI?KURLAROAD,?ANDHERI?(EAST),, MUMBAI?\/?MAHARASHTRA","customerAddress":""},{"dataSource":"API 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UNITED ARAB EMIRATES United Arab Emirates","customerAddress":"N\/A"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743705000,"product":"ANASTROZOLE BATCH NO ANB2503002 (FOR THIRD COUNTRY RE-EXPORT)ANASTROZOLE BATCH NO ANB2503002 (FOR THIRD COUNTRY RE-EXPORT","address":"N\/A","city":"","supplier":"ANARITI TRADING FZE","supplierCountry":"CHINA","foreign_port":"PADANG","customer":"NIRANTARA TRADING PRIVATE LIMITED","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"25600","totalValueFC":"77695.6","currency":"USD","unitRateINR":"2216960","date":"04-Apr-2025","totalValueINR":"6650880","totalValueInUsd":"77695.6","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"9293658","productDescription":"Re-export","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"PADANG","supplierAddress":"AJMAN FREE ZONE B1 BUILDING EXECUTI VE OFFICE B1-309 PO BOX 4235 AJMAN, UNITED ARAB EMIRATES United Arab Emirates","customerAddress":"N\/A"}]
    08-Feb-2021
    26-Apr-2025
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    Drugs in Development

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    • Development Update
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    Puma Starts ALISCA™-Breast1 Trial for Alisertib in HR+, HER2- Breast Cancer

    Details:

    MLN8237 (alisertib) is a high affinity, selective, orally bioavailable inhibitors of Aurora A. It is being developed for the treatment of HER2-negative, HR-positive metastatic breast cancer.


    Lead Product(s): Alisertib,Anastrozole,Letrozole

    Therapeutic Area: Oncology Brand Name: MLN8237

    Study Phase: Phase IIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 20, 2024

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    01

    Puma Biotechnology

    U.S.A
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    IPEC-Americas
    Not Confirmed

    Puma Biotechnology

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Alisertib,Anastrozole,Letrozole

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Puma Starts ALISCA™-Breast1 Trial for Alisertib in HR+, HER2- Breast Cancer

    Details : MLN8237 (alisertib) is a high affinity, selective, orally bioavailable inhibitors of Aurora A. It is being developed for the treatment of HER2-negative, HR-positive metastatic breast cancer.

    Product Name : MLN8237

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    November 20, 2024

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    Puma Biotechnology Allowed to Proceed Under IND for Alisertib in Metastatic Breast Cancer

    Details:

    MLN8237 (alisertib) is a high affinity, selective, orally bioavailable inhibitors of Aurora A. It is being developed for the treatment of HER2-negative, HR-positive metastatic breast cancer.


    Lead Product(s): Alisertib,Anastrozole

    Therapeutic Area: Oncology Brand Name: MLN8237

    Study Phase: Phase IProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 20, 2024

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    02

    Puma Biotechnology

    U.S.A
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    IPEC-Americas
    Not Confirmed

    Puma Biotechnology

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Alisertib,Anastrozole

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Puma Biotechnology Allowed to Proceed Under IND for Alisertib in Metastatic Breast Cancer

    Details : MLN8237 (alisertib) is a high affinity, selective, orally bioavailable inhibitors of Aurora A. It is being developed for the treatment of HER2-negative, HR-positive metastatic breast cancer.

    Product Name : MLN8237

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 20, 2024

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    Puma Biotechnology Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

    Details:

    MLN8237 (alisertib) is a high affinity, selective, orally bioavailable inhibitors of Aurora A. It is being developed for the treatment of HER2-negative, HR-positive metastatic breast cancer.


    Lead Product(s): Alisertib,Anastrozole

    Therapeutic Area: Oncology Brand Name: MLN8237

    Study Phase: Phase IIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 12, 2023

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    03

    Puma Biotechnology

    U.S.A
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    Not Confirmed

    Puma Biotechnology

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Alisertib,Anastrozole

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Puma Biotechnology Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormon...

    Details : MLN8237 (alisertib) is a high affinity, selective, orally bioavailable inhibitors of Aurora A. It is being developed for the treatment of HER2-negative, HR-positive metastatic breast cancer.

    Product Name : MLN8237

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    November 12, 2023

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    Context Therapeutics Highlights Clinical Responses from the Phase 2 OATH Clinical Trial Evaluating ONA-XR for the Treatment of Endometrial Cancer

    Details:

    ONA-XR (onapristone) is a selective progesterone receptor (PR) antagonist designed to block both ligand dependent and ligand-independent activity of PR which downregulates cancer stem cellmobilization, and blocking immune evasion.


    Lead Product(s): Onapristone,Anastrozole

    Therapeutic Area: Oncology Brand Name: ONA-XR

    Study Phase: Phase IIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 02, 2023

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    04

    Context Therapeutics

    U.S.A
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    IPEC-Americas
    Not Confirmed

    Context Therapeutics

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Onapristone,Anastrozole

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Context Therapeutics Highlights Clinical Responses from the Phase 2 OATH Clinical Trial Evaluating...

    Details : ONA-XR (onapristone) is a selective progesterone receptor (PR) antagonist designed to block both ligand dependent and ligand-independent activity of PR which downregulates cancer stem cellmobilization, and blocking immune evasion.

    Product Name : ONA-XR

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    June 02, 2023

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    Lilly to Present Final Overall Survival Analysis from the MONARCH 3 Study of Verzenio® (abemaciclib) and Additional Results from Its Breast Cancer Port...

    Details:

    Verzenio (abemaciclib) is a small molecule CDK4/CD6 inhibitor which is under phase 3 clinical development in combination with anastrozole for the treatment of post-menopausal patients with HR+/HER2-, advanced or metastatic breast cancer.


    Lead Product(s): Abemaciclib,Anastrozole

    Therapeutic Area: Oncology Brand Name: Verzenio

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 12, 2023

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    05

    Eli Lilly

    U.S.A
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    Bioequity Europe
    Not Confirmed

    Eli Lilly

    U.S.A
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    Bioequity Europe
    Not Confirmed
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    Lead Product(s) : Abemaciclib,Anastrozole

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lilly to Present Final Overall Survival Analysis from the MONARCH 3 Study of Verzenio® (abemacicl...

    Details : Verzenio (abemaciclib) is a small molecule CDK4/CD6 inhibitor which is under phase 3 clinical development in combination with anastrozole for the treatment of post-menopausal patients with HR+/HER2-, advanced or metastatic breast cancer.

    Product Name : Verzenio

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    May 12, 2023

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    Novartis Kisqali® Phase III NATALEE Trial Meets Primary Endpoint at Interim Analysis Demonstrating Clinically Meaningful Benefit in Broad Population of...

    Details:

    Kisqali® (ribociclib) is the only USFDA approved category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- MBC when combined with an AI.


    Lead Product(s): Ribociclib,Anastrozole

    Therapeutic Area: Oncology Brand Name: Kisqali

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 27, 2023

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    06

    Translational Research In Oncology

    Canada
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    IPEC-Americas
    Not Confirmed

    Translational Research In Oncology

    Canada
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    IPEC-Americas
    Not Confirmed
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    Lead Product(s) : Ribociclib,Anastrozole

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Novartis Kisqali® Phase III NATALEE Trial Meets Primary Endpoint at Interim Analysis Demonstratin...

    Details : Kisqali® (ribociclib) is the only USFDA approved category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- MBC when combined with an AI.

    Product Name : Kisqali

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 27, 2023

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    Clarus Therapeutics Announces Notice of Allowance for Patent Claims Covering CLAR-121 (Testosterone + Anastrozole) for Treatment of Androgen-Mediated Au...

    Details:

    CLAR-121 is combination of testosterone undecanoate (natural ligand for the androgen receptor and anastrozole delivered by a subcutaneous implant for treatment of AR-mediated inflammatory breast disease that predominantly affects women.


    Lead Product(s): Testosterone Undecanoate,Anastrozole

    Therapeutic Area: Immunology Brand Name: Jatenzo

    Study Phase: Phase IProduct Type: Hormone

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 05, 2022

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    07

    Clarus Therapeutics

    U.S.A
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    IPEC-Americas
    Not Confirmed

    Clarus Therapeutics

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Testosterone Undecanoate,Anastrozole

    Therapeutic Area : Immunology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Clarus Therapeutics Announces Notice of Allowance for Patent Claims Covering CLAR-121 (Testosteron...

    Details : CLAR-121 is combination of testosterone undecanoate (natural ligand for the androgen receptor and anastrozole delivered by a subcutaneous implant for treatment of AR-mediated inflammatory breast disease that predominantly affects women.

    Product Name : Jatenzo

    Product Type : Hormone

    Upfront Cash : Inapplicable

    October 05, 2022

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    Novartis Kisqali® Prolonged PFS Benefit for Pre- and Perimenopausal Patients with Aggressive HR+/HER2− Metastatic Breast Cancer Compared to Chemother...

    Details:

    Kisqali (ribociclib) is the only CDK4/6 inhibitor with proven overall survival benefit across all three pivotal Phase III advanced breast cancer trials and is recognized as the only CDK4/6i with overall survival benefit in first-line HR+/HER2- advanced breast cancer.


    Lead Product(s): Ribociclib,Anastrozole,Goserelin Acetate

    Therapeutic Area: Oncology Brand Name: Kisqali

    Study Phase: Phase IIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 12, 2022

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    08

    Novartis Pharmaceuticals Corporation

    Switzerland
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    IPEC-Americas
    Not Confirmed

    Novartis Pharmaceuticals Corporation

    Switzerland
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    Not Confirmed
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    Lead Product(s) : Ribociclib,Anastrozole,Goserelin Acetate

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Novartis Kisqali® Prolonged PFS Benefit for Pre- and Perimenopausal Patients with Aggressive HR+/...

    Details : Kisqali (ribociclib) is the only CDK4/6 inhibitor with proven overall survival benefit across all three pivotal Phase III advanced breast cancer trials and is recognized as the only CDK4/6i with overall survival benefit in first-line HR+/HER2- advanced b...

    Product Name : Kisqali

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    June 12, 2022

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    Context Therapeutics Announces Poster Presentation at the Upcoming 2022 ASCO Annual Meeting

    Details:

    Lead clinical-stage oral progesterone receptor (PR) antagonist ONA-XR (onapristone extended release) demonstrates monotherapy clinical activity in advanced granulosa cell tumor of the ovary.


    Lead Product(s): Onapristone,Anastrozole

    Therapeutic Area: Oncology Brand Name: ONA-XR

    Study Phase: Phase IIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 05, 2022

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    09

    Context Therapeutics

    U.S.A
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    Not Confirmed

    Context Therapeutics

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Onapristone,Anastrozole

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Context Therapeutics Announces Poster Presentation at the Upcoming 2022 ASCO Annual Meeting

    Details : Lead clinical-stage oral progesterone receptor (PR) antagonist ONA-XR (onapristone extended release) demonstrates monotherapy clinical activity in advanced granulosa cell tumor of the ovary.

    Product Name : ONA-XR

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    May 05, 2022

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    Clarus Therapeutics and HavaH Therapeutics Announce Licensing Agreement

    Details:

    CLAR-121 is a proprietary combination of testosterone (T) (natural ligand for the androgen receptor; AR) and anastrozole (inhibitor of T conversion to estradiol) delivered by a subcutaneous implant for treatment of AR-mediated breast disease that predominantly affects women.


    Lead Product(s): Testosterone,Anastrozole

    Therapeutic Area: Immunology Brand Name: CLAR-121

    Study Phase: UndisclosedProduct Type: Hormone

    Sponsor: Clarus Therapeutics

    Deal Size: $11.2 million Upfront Cash: $0.5 million

    Deal Type: Licensing Agreement May 25, 2021

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    HavaH Therapeutics

    Australia
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    Not Confirmed

    HavaH Therapeutics

    Australia
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    Lead Product(s) : Testosterone,Anastrozole

    Therapeutic Area : Immunology

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Clarus Therapeutics

    Deal Size : $11.2 million

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Clarus Therapeutics and HavaH Therapeutics Announce Licensing Agreement

    Details : CLAR-121 is a proprietary combination of testosterone (T) (natural ligand for the androgen receptor; AR) and anastrozole (inhibitor of T conversion to estradiol) delivered by a subcutaneous implant for treatment of AR-mediated breast disease that predomi...

    Product Name : CLAR-121

    Product Type : Hormone

    Upfront Cash : $0.5 million

    May 25, 2021

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    INTERMEDIATE SUPPLIERS

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    01

    Suanfarma

    Spain
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    2,2'-(5-Methylbenzene-1,3-Diyl)Bis(2-Methylpropane...

    CAS Number : 120511-72-0

    End Use API : Anastrozole

    About The Company : Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the ...

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    Dasami Lab

    India
    BPI Europe
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    1,2,4-SODIUM TRIAZOLE

    CAS Number : 41253-21-8

    End Use API : Anastrozole

    About The Company : Dasami Lab Private Limited incorporated with MCA on 24 July 2015. The Dasami Lab Private Limited is listed in the class of pvtltd company and classified as Non ...

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    03

    Innovassynth Technologies (I) Ltd

    India
    BPI Europe
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    India
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    3,5-Bis (2-cyanoprop-2-yl )benzyl

    CAS Number : 120511-84-4

    End Use API : Anastrozole

    About The Company : Innovassynth Technologies (I) Ltd. formerly known as Chemicals Division of Indian Organic Chemicals Ltd. came in to existence since 1st August 2002. It is a par...

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    04

    Innovassynth Technologies (I) Ltd

    India
    BPI Europe
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    3,5-Bis 2-cyano isopropyl toluene

    CAS Number : 120511-72-0

    End Use API : Anastrozole

    About The Company : Innovassynth Technologies (I) Ltd. formerly known as Chemicals Division of Indian Organic Chemicals Ltd. came in to existence since 1st August 2002. It is a par...

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    Integrin Life Sciences

    India
    BPI Europe
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    Integrin Life Sciences

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    3,5-Bis(2-cyanoisopropyl)toluene

    CAS Number : 120511-72-0

    End Use API : Anastrozole

    About The Company : Integrin Life Sciences Pvt. Ltd. is one of the growing pharmaceutical API, advanced chemical intermediates manufacturing companies in India. Our Plant is Locate...

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    Kores India Limited

    India
    BPI Europe
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    Kores India Limited

    India
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    1-Methylbenzene-3,5-diacetonitrile

    CAS Number : 120511-74-2

    End Use API : Anastrozole

    About The Company : The division was established in 1981 as a Specialty Chemicals Division with a focus to manufacture specialty chemicals and pharmaceutical intermediates. In Apri...

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    Kores India Limited

    India
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    3,5-(2-Methylpropionitrilo) toluene

    CAS Number : 120511-72-0

    End Use API : Anastrozole

    About The Company : The division was established in 1981 as a Specialty Chemicals Division with a focus to manufacture specialty chemicals and pharmaceutical intermediates. In Apri...

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    Kores India Limited

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    3,5-(2-Methylpropionitrilo) benzylbromide

    CAS Number : 120511-84-4

    End Use API : Anastrozole

    About The Company : The division was established in 1981 as a Specialty Chemicals Division with a focus to manufacture specialty chemicals and pharmaceutical intermediates. In Apri...

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    Luna Chemicals

    China
    BPI Europe
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    Luna Chemicals

    China
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    3,5-Bis-(2-cyanoisopropyl) toluene

    CAS Number : 1210-35-1

    End Use API : Anastrozole

    About The Company : LUNA Chemicals Co.,Ltd. markets and manufactures world-class quality Active Pharmaceutical Ingredients and intermediate chemicals for generic pharmaceutical com...

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    Prajna Generics

    India
    BPI Europe
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    Prajna Generics

    India
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    2,2'-(5-Bromomethyl-1,3-phenylene)-di(2- Methylpro...

    CAS Number : 120511-84-4

    End Use API : Anastrozole

    About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...

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    ABOUT THIS PAGE

    Looking for 120511-73-1 / Anastrozole API manufacturers, exporters & distributors?

    Anastrozole manufacturers, exporters & distributors 1

    21

    PharmaCompass offers a list of Anastrozole 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 Anastrozole manufacturer or Anastrozole supplier for your needs.

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

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

    API | Excipient name

    Anastrozole

    Synonyms

    120511-73-1, Arimidex, Anastrazole, Anastrozol, Zd1033, 2,2'-(5-((1h-1,2,4-triazol-1-yl)methyl)-1,3-phenylene)bis(2-methylpropanenitrile)

    Cas Number

    120511-73-1

    Unique Ingredient Identifier (UNII)

    2Z07MYW1AZ

    About Anastrozole

    A nitrile and triazole derivative that acts as a selective nonsteroidal aromatase inhibitor. It is used in the treatment of ESTROGEN NUCLEAR RECEPTOR-positive breast cancer in postmenopausal women.

    Anastrozole Manufacturers

    A Anastrozole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Anastrozole, including repackagers and relabelers. The FDA regulates Anastrozole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Anastrozole 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 Anastrozole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Anastrozole Suppliers

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

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

    Anastrozole USDMF

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

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

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

    Anastrozole 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 Anastrozole Drug Master File in Japan (Anastrozole JDMF) empowers Anastrozole 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 Anastrozole JDMF during the approval evaluation for pharmaceutical products. At the time of Anastrozole 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 Anastrozole suppliers with JDMF on PharmaCompass.

    Anastrozole KDMF

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

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

    After submitting a Anastrozole 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 Anastrozole API can apply through the Korea Drug Master File (KDMF).

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

    Anastrozole CEP

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

    A Anastrozole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Anastrozole 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 Anastrozole suppliers with CEP (COS) on PharmaCompass.

    Anastrozole WC

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

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

    Anastrozole 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 Anastrozole as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Anastrozole 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 Anastrozole 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 Anastrozole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Anastrozole NDC to their finished compounded human drug products, they may choose to do so.

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

    Anastrozole GMP

    Anastrozole 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 Anastrozole 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 Anastrozole GMP manufacturer or Anastrozole GMP API supplier for your needs.

    Anastrozole CoA

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

    Anastrozole CoA mostly includes findings from lab analyses of a specific batch. For each Anastrozole 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.

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