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    Chemistry

    Click the arrow to open the dropdown
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    read-moreClick the button for full data set
    Also known as: 164656-23-9, Avodart, Avolve, Gg-745, Gi 198745, Gi-198745
    Molecular Formula
    C27H30F6N2O2
    Molecular Weight
    528.5  g/mol
    InChI Key
    JWJOTENAMICLJG-QWBYCMEYSA-N
    FDA UNII
    O0J6XJN02I
    Dutasteride
    A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA.
    Dutasteride is a 5-alpha Reductase Inhibitor. The mechanism of action of dutasteride is as a 5-alpha Reductase Inhibitor.
    1 2D Structure

    Dutasteride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1S,3aS,3bS,5aR,9aR,9bS,11aS)-N-[2,5-bis(trifluoromethyl)phenyl]-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide
    2.1.2 InChI
    InChI=1S/C27H30F6N2O2/c1-24-11-9-17-15(4-8-21-25(17,2)12-10-22(36)35-21)16(24)6-7-19(24)23(37)34-20-13-14(26(28,29)30)3-5-18(20)27(31,32)33/h3,5,10,12-13,15-17,19,21H,4,6-9,11H2,1-2H3,(H,34,37)(H,35,36)/t15-,16-,17-,19+,21+,24-,25+/m0/s1
    2.1.3 InChI Key
    JWJOTENAMICLJG-QWBYCMEYSA-N
    2.1.4 Canonical SMILES
    CC12CCC3C(C1CCC2C(=O)NC4=C(C=CC(=C4)C(F)(F)F)C(F)(F)F)CCC5C3(C=CC(=O)N5)C
    2.1.5 Isomeric SMILES
    C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@H]2C(=O)NC4=C(C=CC(=C4)C(F)(F)F)C(F)(F)F)CC[C@@H]5[C@@]3(C=CC(=O)N5)C
    2.2 Other Identifiers
    2.2.1 UNII
    O0J6XJN02I
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 17beta-n-(2,5-bis(trifluoromethyl))phenyl-carbamoyl-4-aza-5alpha-androst-1-en-3-one

    2. 745, Gg

    3. Avodart

    4. Gg 745

    5. Gg-745

    6. Gg745

    7. Gi198745

    2.3.2 Depositor-Supplied Synonyms

    1. 164656-23-9

    2. Avodart

    3. Avolve

    4. Gg-745

    5. Gi 198745

    6. Gi-198745

    7. Gg 745

    8. Duastride

    9. (1s,3as,3bs,5ar,9ar,9bs,11as)-n-[2,5-bis(trifluoromethyl)phenyl]-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide

    10. Nsc-740477

    11. O0j6xjn02i

    12. (5alpha,17beta)-n-(2,5-bis(trifluoromethyl)phenyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide

    13. Alpha,alpha,alpha,alpha',alpha',alpha'-hexafluoro-3-oxo-4-aza-5alpha-androst-1-ene-17beta-carboxy-2',5'-xylidide

    14. Chembl1200969

    15. Chebi:521033

    16. Nsc-759880

    17. (1s,3as,3bs,5ar,9ar,11as)-n-[2,5-bis(trifluoromethyl)phenyl]-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide

    18. (4ar,4bs,6as,7s,9as,9bs,11ar)-n-(2,5-bis(trifluoromethyl)phenyl)-4a,6a-dimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-1h-indeno[5,4-f]quinoline-7-carboxamide

    19. (1s,2r,7r,10s,11s,14s,15s)-n-[2,5-bis(trifluoromethyl)phenyl]-2,15-dimethyl-5-oxo-6-azatetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-3-ene-14-carboxamide

    20. Dutasteride [usan]

    21. Duagen

    22. 1h-indeno[5,4-f]quinoline-7-carboxamide, N-[2,5-bis(trifluoromethyl)phenyl]-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-4a,6a-dimethyl-2-oxo-, (4ar,4bs,6as,7s,9as,9bs,11ar)-

    23. Avodart (tn)

    24. Unii-o0j6xjn02i

    25. Avidart

    26. Gi198745

    27. Dutasteride [usan:inn:ban]

    28. Ncgc00164571-01

    29. (5alpha,17beta)-n-[2,5-bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-1-ene-17-carboxamide

    30. 1h-indeno(5,4-f)quinoline-7-carboxamide, N-(2,5-bis(trifluoromethyl)phenyl)-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-4a,6a-dimethyl-2-oxo-, (4ar,4bs,6as,7s,9as,9bs,11ar)-

    31. Dutasteride- Bio-x

    32. Gi-198745x

    33. Dutasteride [mi]

    34. Dutasteride [inn]

    35. Dutasteride [jan]

    36. Dutasteride [vandf]

    37. Schembl5903

    38. Dsstox_cid_26452

    39. Dsstox_rid_81626

    40. Dutasteride [mart.]

    41. Dsstox_gsid_46452

    42. Dutasteride [usp-rs]

    43. Dutasteride [who-dd]

    44. Dutasteride (jan/usp/inn)

    45. Gtpl7457

    46. Dtxsid8046452

    47. Dutasteride, >=98% (hplc)

    48. Dutasteride [orange Book]

    49. Dutasteride For System Suitability

    50. Jalyn Component Dutasteride

    51. Bcpp000248

    52. Dutasteride [ep Monograph]

    53. Dutasteride [usp Monograph]

    54. Bcp02344

    55. Ex-a1952

    56. Zinc3932831

    57. Tox21_112199

    58. Bdbm50340481

    59. Mfcd00937869

    60. Nsc740477

    61. S1202

    62. Dutasteride Component Of Jalyn

    63. Akos015920136

    64. Akos015924431

    65. Bcp9000630

    66. Ccg-269904

    67. Cs-1542

    68. Db01126

    69. Gs-3565

    70. Nsc 740477

    71. Nsc 759880

    72. N-[2,5-bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5alpha-androst-1-ene-17beta-carboxamide

    73. Bd164398

    74. Hy-13613

    75. Cas-164656-23-9

    76. D5973

    77. D03820

    78. Ab01274774-01

    79. Ab01274774_02

    80. 656d239

    81. A810580

    82. Q424760

    83. Q-201052

    84. Brd-k30373883-001-02-8

    85. Z1563146168

    86. Dutasteride, European Pharmacopoeia (ep) Reference Standard

    87. Dutasteride, United States Pharmacopeia (usp) Reference Standard

    88. 4-azaandrost-1-ene-17-carboxamide, N-[2,5-bis(trifluoromethyl)phenyl]-3-oxo-, (5a,17b)-

    89. Dutasteride For System Suitability, European Pharmacopoeia (ep) Reference Standard

    90. (4ar,4bs,6as,7s,9as,9bs,11ar)-n-[2,5-bis(trifluoromethyl)phenyl]-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-4a,6a-dimethyl-2-oxo-1h-indeno[5,4-f]quinoline-7-carboxamide

    91. (5.alpha.,17.beta.)-n-(2,5-bis(trifluoromethyl)phenyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide

    92. (5.alpha.,5 Bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide;dutasteride;avodart;

    93. (5alpha,17beta)-n-{2,5-bis(trifluoromethyl)-phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide

    94. .alpha.,.alpha.,.alpha.,.alpha.',.alpha.',.alpha.'-hexafluoro-3-oxo-4-aza-5.alpha.-androst-1-ene-17.beta.-carboxy-2',5'-xylidide

    2.4 Create Date
    2006-07-28
    3 Chemical and Physical Properties
    Molecular Weight 528.5 g/mol
    Molecular Formula C27H30F6N2O2
    XLogP35.4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count2
    Exact Mass528.22114718 g/mol
    Monoisotopic Mass528.22114718 g/mol
    Topological Polar Surface Area58.2 Ų
    Heavy Atom Count37
    Formal Charge0
    Complexity964
    Isotope Atom Count0
    Defined Atom Stereocenter Count7
    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 NameAvodart
    PubMed HealthDutasteride (By mouth)
    Drug ClassesBenign Prostatic Hypertrophy Agent
    Drug LabelAVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5,17...
    Active IngredientDutasteride
    Dosage FormCapsule
    RouteOral
    Strength0.5mg
    Market StatusPrescription
    CompanyGlaxosmithkline

    2 of 4  
    Drug NameDutasteride
    PubMed HealthDutasteride (By mouth)
    Drug ClassesBenign Prostatic Hypertrophy Agent
    Drug LabelAVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5,17...
    Active IngredientDutasteride
    Dosage FormCapsule
    Routeoral; Oral
    Strength0.5mg
    Market StatusTentative Approval; Prescription
    CompanyEndo Pharms; Sandoz; Banner Pharmacaps; Roxane; Barr

    3 of 4  
    Drug NameAvodart
    PubMed HealthDutasteride (By mouth)
    Drug ClassesBenign Prostatic Hypertrophy Agent
    Drug LabelAVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5,17...
    Active IngredientDutasteride
    Dosage FormCapsule
    RouteOral
    Strength0.5mg
    Market StatusPrescription
    CompanyGlaxosmithkline

    4 of 4  
    Drug NameDutasteride
    PubMed HealthDutasteride (By mouth)
    Drug ClassesBenign Prostatic Hypertrophy Agent
    Drug LabelAVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5,17...
    Active IngredientDutasteride
    Dosage FormCapsule
    Routeoral; Oral
    Strength0.5mg
    Market StatusTentative Approval; Prescription
    CompanyEndo Pharms; Sandoz; Banner Pharmacaps; Roxane; Barr

    4.2 Drug Indication

    Indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland to improve symptoms, and reduce the risk of acute urinary retention and the need for BPH-related surgery alone or in combination with [tamsulosin].

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Dutasteride is a synthetic 4-azasteroid compound that selectively inhibits both the type I and type II isoforms of steroid 5-reductase, an intracellular enzyme that converts testosterone to 5-dihydrotestosterone (DHT). Dutasteride works by reducing the levels of circulating DHT. It was also shown to reduce the size of the prostate gland, improve urinary flow, and symptoms of benign prostatic hyperplasia alone or in combination with tamsulosin. The effect of the reduction of DHT by dutasteride is dose-dependent, with the maximum effect observed within 1-2 weeks following initial administration. After 1 and 2 weeks of daily dosing with dutasteride 0.5 mg, median serum DHT concentrations were reduced by 85% and 90%, respectively. The serum concentrations of DHT were maintained to be decreased by more than 90% in 85% of patients following 1 years' administration of oral dutasteride 0.5 mg/day. As evident from the clinical studies, dutasteride may also cause decreases in serum PSA in the presence of prostate cancer.

    5.2 MeSH Pharmacological Classification

    5-alpha Reductase Inhibitors

    Drugs that inhibit 3-OXO-5-ALPHA-STEROID 4-DEHYDROGENASE. They are commonly used to reduce the production of DIHYDROTESTOSTERONE. (See all compounds classified as 5-alpha Reductase Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    DUTASTERIDE
    5.3.2 FDA UNII
    O0J6XJN02I
    5.3.3 Pharmacological Classes
    5-alpha Reductase Inhibitors [MoA]; 5-alpha Reductase Inhibitor [EPC]
    5.4 ATC Code

    G04CB02

    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

    G - Genito urinary system and sex hormones

    G04 - Urologicals

    G04C - Drugs used in benign prostatic hypertrophy

    G04CB - Testosterone-5-alpha reductase inhibitors

    G04CB02 - Dutasteride

    5.5 Absorption, Distribution and Excretion

    Absorption

    Following oral administration of a single dose of 0.5 mg dutasteride, the peak serum concentrations were reached within 2 to 3 hours. Following daily oral administration of 0.5 mg dutasteride, the steady-state concentration of 40 ng/mL is expected to be achieved at 6 months following initial administration. In healthy subjects, the absolute bioavailability was 60%, ranging from 40% to 94%. While food intake reduced the maximum serum concentrations by 10 to 15%, food intake is reported to have a negligible effect on the bioavailability of the drug.

    Route of Elimination

    Dutasteride and its metabolites mainly undergo fecal excretion. About 1-15% of the dose is excreted as the unchanged parent compound, while 2-90% of the total dose is excreted in the form of dutasteride-related metabolites in the feces. Trace amounts of unchanged dutasteride, with less than 1%, can also be detected in the urine. Therefore, on average, the dose unaccounted for approximated 55%, with a range between 5% and 97%.

    Volume of Distribution

    Dutasteride displays a large volume of distribution ranging from 300 to 500 L. Following daily oral administration of 0.5 mg dutasteride healthy subjects for 12 months, the semen dutasteride concentrations averaged 3.4 ng/mL (range: 0.4 to 14 ng/mL) with 11.5% of serum dutasteride concentrations being partitioned into semen.

    Clearance

    In a study of healthy volunteers receiving single oral doses of dutasteride ranging from 0.01 to 40 mg, dutasteride displayed a low linear clearance of 0.58 L/h. The estimated inter-individual variability for the linear clearance was high.

    5.6 Metabolism/Metabolites

    Dutasteride undergoes extensive hepatic metabolism mediated by CYP3A4 and CYP3A5. 4-hydroxydutasteride, 6-hydroxydutasteride, 6,4-dihydroxydutasteride, 1,2-dihydrodutasteride, and 15-hydroxydutasteride metabolites are formed. 2 minor metabolites - 6,4-dihydroxydutasteride and 15-hydroxydutasteride - can also be detected. According to _in vitro_ studies, 4-hydroxydutasteride and 1,2-dihydrodutasteride mediated inhibitory actions against both isoforms of 5-reductase but with lower potency when compared to the parent drug. The activity of 6-hydroxydutasteride is comparable to that of dutasteride.

    5.7 Biological Half-Life

    The terminal elimination half-life of dutasteride is approximately 5 weeks at steady state. This long half-life accounts for the serum concentrations remaining detectable for up to 4 to 6 months after discontinuation of treatment.

    5.8 Mechanism of Action

    The 5-reductase is a nuclear-bound steroid intracellular enzyme primarily located in the prostatic stromal cell that converts the androgen testosterone into the more active metabolite, 5-dihydrotestosterone (DHT). DHT is considered to be the primary androgen playing a role in the initial development and subsequent enlargement of the prostate gland. It serves as the hormonal mediator for the hyperplasia upon accumulation within the prostate gland. DHT displays a higher affinity towards androgen receptors in the prostate gland compared to testosterone and by acting on the androgen receptors, DHT modulates genes that are responsible for cell proliferation. Responsible for the synthesis of approximately one-third of circulating DHT, type I 5-reductase is predominant in the sebaceous glands of most regions of skin, including the scalp, and liver. The type II 5a-reductase isozyme is primarily found in the prostate, seminal vesicles, epididymides, and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT. Due to its dual inhibition of both isoenzymes of 5-reductase, dutasteride causes a near-complete suppression of DHT. Compared to a 70% reduction of serum DHT levels caused by [finasteride], a near-complete suppression of serum DHT-more than 90% is seen with dutasteride. By forming a stable complex with both type II and type II 5-reductase, dutasteride inhibits its enzymatic action of converting testosterone to 5-dihydrotestosterone (DHT), which is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. It is proposed that DHT is the principal androgen responsible for prostatic growth in later life-normal masculinization of the external genitalia and maturation of the prostate gland during development-thus reducing the serum DHT levels results in reduced prostatic volume and increased epithelial apoptosis. Dutasteride is a competitive and specific inhibitor of both Type I and Type II 5-reductase isoenzymes and when evaluated under _in vitro_ and _in vivo_ conditions, the dissociation of the drug from the drug-enzyme complex is reported to be extremely slow. Dutasteride does not bind to the human androgen receptor.

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    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    Available Reg Filing : AU
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    HRV Global Life Sciences

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    Tenatra Chemie

    India

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    Tenatra

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    08

    Human Pharmalabs

    India

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    Virtual BoothHuman Pharmalabs manufacturer of high quality corticosteroid APIs with a state of the art facility in Kalol Gandhinagar.

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    09

    Dr. Reddy's Laboratories

    India

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

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-12

    Pay. Date : 2012-11-30

    DMF Number : 26475

    Submission : 2012-10-03

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-06-06

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0034Amended

    Address of the Firm :

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    ✖

    NDC Package Code : 55111-076

    Start Marketing Date : 2012-08-16

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    ✖

    Registrant Name : EQ Bio Co., Ltd.

    Registration Date : 2024-10-25

    Registration Number : No. 4692-3-ND(3)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri Venkateswara Co-operative Industrial Estate Bollaram, Jinnaram Mandal, Sangareddy District, Telangana, 502325 INDIA

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    10

    Dr. Reddy's Laboratories

    India

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

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    CPhI Korea
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    Registrant Name : YuYu Pharmaceutical Co., Ltd.

    Registration Date : 2011-09-02

    Registration Number : No. 4692-3-ND(1)

    Manufacturer Name : Dr. Reddy\'s Laboratories Limited

    Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri Venkateswara Co-operative Industrial Estate Bollaram, Jinnaram Mandal, Sangareddy District, Telangana, 502325 INDIA

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    Dr Reddys Laboratories Ltd

    India
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-08-12

    Pay. Date : 2012-11-30

    DMF Number : 26475

    Submission : 2012-10-03

    Status : Active

    Type : II

    Dr Reddy Company Banner

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    02

    EPSC
    Not Confirmed

    02

    Catalent Pharma Solutions Llc

    U.S.A
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    EPSC
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24304

    Submission : 2010-10-19

    Status : Inactive

    Type : II

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    03

    EPSC
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    03

    Catalent France Beinheim Sa

    U.S.A
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    EPSC
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14643

    Submission : 1999-12-22

    Status : Inactive

    Type : II

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    04

    Cipla Ltd

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20180

    Submission : 2009-05-06

    Status : Inactive

    Type : II

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    05

    Gador Sa

    Argentina

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    Not Confirmed

    05

    Gador Sa

    Argentina
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    EPSC
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23810

    Submission : 2010-05-18

    Status : Inactive

    Type : II

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    06

    EPSC
    Not Confirmed

    06

    Hubei Gedian Humanwell Pharmaceutica...

    China
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    EPSC
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-06-24

    Pay. Date : 2021-04-02

    DMF Number : 26803

    Submission : 2013-01-09

    Status : Active

    Type : II

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    07

    EPSC
    Not Confirmed

    07

    Msn Laboratories Private Ltd

    India
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    EPSC
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-01-09

    Pay. Date : 2012-12-06

    DMF Number : 23533

    Submission : 2010-02-16

    Status : Active

    Type : II

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    08

    EPSC
    Not Confirmed

    08

    Fis Fabbrica Italiana Sintetici Spa

    Switzerland
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    EPSC
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23494

    Submission : 2010-04-30

    Status : Inactive

    Type : II

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    09

    EPSC
    Not Confirmed

    09

    Reliance Life Sciences Pvt Ltd

    India
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    EPSC
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24880

    Submission : 2011-07-29

    Status : Inactive

    Type : II

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    10

    Sterling Spa

    Italy

    USDMF

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    EPSC
    Not Confirmed

    10

    Sterling Spa

    Italy
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    EPSC
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-05-07

    Pay. Date : 2015-04-30

    DMF Number : 20918

    Submission : 2007-10-08

    Status : Active

    Type : II

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    CEP/COS

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    APITORIA PHARMA PRIVATE LIMITED Hyd...

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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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    Dutasteride

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    CEP 2014-306 - Rev 02
    Valid
    Chemical
    2025-05-13
    2641
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    01

    APITORIA PHARMA PRIVATE LIMITED Hyd...

    India
    EPSC
    Not Confirmed
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    CIPLA LIMITED Mumbai IN

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    R0-CEP 2015-050 - Rev 00
    Withdrawn by Holder
    Chemical
    2017-06-15
    2022-03-01
    2641
    blank

    02

    HETERO LABS LIMITED Hyderabad IN

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    R1-CEP 2016-126 - Rev 00
    Valid
    Chemical
    2022-07-26
    2641
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    03

    HETERO LABS LIMITED Hyderabad IN

    India
    EPSC
    Not Confirmed
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    HETERO LABS LIMITED Hyderabad IN

    India
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    EPSC
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    • 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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    Dutasteride

    Certificate Number : R1-CEP 2016-126 - Rev 00

    Status : Valid

    Issue Date : 2022-07-26

    Type : Chemical

    Substance Number : 2641

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    Dutasteride, Non-micronised and micronised

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    CEP 2020-298 - Rev 02
    Valid
    Chemical
    2024-12-13
    2641
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    04

    Hubei Gedian Humanwell Pharmaceutic...

    China
    EPSC
    Not Confirmed
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    MSN LABORATORIES PRIVATE LIMITED Ru...

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    Dutasteride, Crystalline Form-I, Micronised and Non-mic...

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    CEP 2014-019 - Rev 01
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    Chemical
    2024-12-16
    2641
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    05

    MSN LABORATORIES PRIVATE LIMITED Ru...

    India
    EPSC
    Not Confirmed
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    MSN LABORATORIES PRIVATE LIMITED Ru...

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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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    Dutasteride, Route "DJ"

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    R1-CEP 2015-252 - Rev 00
    Withdrawn by Holder
    Chemical
    2021-01-15
    2023-09-08
    2641
    blank

    06

    MSN LABORATORIES PRIVATE LIMITED Ru...

    India
    EPSC
    Not Confirmed
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    MSN LABORATORIES PRIVATE LIMITED Ru...

    India
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    EPSC
    Not Confirmed
    • fda
    • EDQM
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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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    Dutasteride, Route "DJ"

    Certificate Number : R1-CEP 2015-252 - Rev 00

    Status : Withdrawn by Holder

    Issue Date : 2021-01-15

    Type : Chemical

    Substance Number : 2641

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    SHAKTI LIFESCIENCE PRIVATE LIMITED ...

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      Dutasteride

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      CEP 2022-172 - Rev 00
      Valid
      Chemical
      2025-02-17
      2641
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      SHAKTI LIFESCIENCE PRIVATE LIMITED ...

      India
      EPSC
      Not Confirmed
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      STERLING CHEMICAL MALTA LTD. Birzeb...

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      Dutasteride, Form I

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      CEP 2015-258 - Rev 01
      Valid
      Chemical
      2024-02-06
      2641
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      STERLING CHEMICAL MALTA LTD. Birzeb...

      Italy
      EPSC
      Not Confirmed
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      SWATI SPENTOSE PRIVATE LIMITED Mumb...

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      Valid
      Chemical
      2025-03-18
      2641
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      09

      SWATI SPENTOSE PRIVATE LIMITED Mumb...

      India
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      Listed Suppliers

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      LGM Pharma

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      Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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      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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      Metrochem API Private Limited

      India
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      Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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      About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

      Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
      Metrochem

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      03

      Dr. Reddy's Laboratories

      India
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      Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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      Dutasteride

      About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

      Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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      04

      Gonane Pharma

      India
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      Virtual BoothGonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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      Dutasteride

      About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...

      Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncology products. The company's core strength lies in its dedicated team, and its promoters bring over 25 years of experience in manufacturing, promoting products, and managing audits for regulated markets such as the EU, Mexico, China, Korea, and Russia. GONANE PHARMA is actively engaged in discussions with Japanese customers and anticipates further expansion into additional markets.
      Gonane Pharma

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      05

      Jai Radhe Sales

      India
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      Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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      About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

      Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
      Jai Radhe Sales

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      06

      HRV Global Life Sciences

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      Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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      Dutasteride

      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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      07

      Tenatra Chemie

      India
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      iPHEX India
      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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      Dutasteride

      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.
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      08

      Human Pharmalabs

      India
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      Virtual BoothHuman Pharmalabs manufacturer of high quality corticosteroid APIs with a state of the art facility in Kalol Gandhinagar.

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      Dutasteride

      About the Company : Human Pharmalabs Pvt. Ltd. was founded to manufacture lifesaving critical APIs in India, pioneering the introduction of Corticosteroid APIs. The company adheres to international st...

      Human Pharmalabs Pvt. Ltd. was founded to manufacture lifesaving critical APIs in India, pioneering the introduction of Corticosteroid APIs. The company adheres to international standards, continuously evolving to meet global pharmaceutical needs. With state-of-the-art laboratories designed for specialized scientific research, Human Pharmalabs ensures innovation and excellence in pharmaceutical manufacturing. Guided by visionary leadership, they remain committed to advancing healthcare solutions.
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      09

      Atomgrid

      India
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      Atomgrid

      India
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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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      About the Company : Atomgrid is a global company that specializes in the manufacturing and sourcing of specialty chemicals. The company manages end-to-end manufacturing and sourcing needs, covering R&...

      Atomgrid is a global company that specializes in the manufacturing and sourcing of specialty chemicals. The company manages end-to-end manufacturing and sourcing needs, covering R&D and lab-scale development to bulk manufacturing and doorstep delivery. Atomgrid employs a proprietary tech platform and a team of experienced chemical engineers, PhDs, and project managers to provide customers with a seamless experience. The company aims to deliver unmatched quality, affordability, and speed in the manufacturing and sourcing of specialty chemicals.
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      10

      Maharshi Pharma Chem

      India
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      Maharshi Pharma Chem

      India
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      Dutasteride

      About the Company : Maharshi Pharmachem is the fastest growing company in India, having plans to expand our market reach further. We have the conviction that all markets should be provided with qualit...

      Maharshi Pharmachem is the fastest growing company in India, having plans to expand our market reach further. We have the conviction that all markets should be provided with quality products. We are constantly working on Regulated and semi-regulated markets by tying up with several partners with common vision and goals. With our present infrastructure, qualitative & quality products, and well-established brand image, as a reliable group of people with the best potential to deliver quality healthcare solutions to the world.
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S.G HIGHWAY, MAKARBA, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753900200,"product":"DUTASTERIDE PH.EUR","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"APITORIA PHARMA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"UNDISCLOSED","customerCountry":"SPAIN","quantity":"24.64","actualQuantity":"24.64","unit":"KGS","unitRateFc":"8100","totalValueFC":"197120.8","currency":"USD","unitRateINR":688530.25365259731,"date":"31-Jul-2025","totalValueINR":"16965385.45","totalValueInUsd":"197120.8","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"4064703","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower, Hyderabad","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706121000,"product":"DUTASTERIDE HYDRATE BATCH NO.DT-005\/20","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"STERLING S P A","supplierCountry":"UNITED STATES","foreign_port":"MIAMI, FL","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.80","actualQuantity":"0.8","unit":"KGS","unitRateFc":"20000","totalValueFC":"16190.3","currency":"USD","unitRateINR":"1682000","date":"25-Jan-2024","totalValueINR":"1345600","totalValueInUsd":"16190.3","indian_port":"Madras Air","hs_no":"29349990","bill_no":"9825072","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"MIAMI, FL","supplierAddress":"RIEDSTRASSE 1CHAM ZUG 6330SDNF SWITZERLAND","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712946600,"product":"DUTASTERIDE BATCH NO. DT240103M1","address":"KENI BUILDING,","city":"PANAJI, GOA","supplier":"HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"WUHAN","customer":"VERGO PHARMA RESEARCH LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"10000","totalValueFC":"3030.3","currency":"USD","unitRateINR":"843500","date":"13-Apr-2024","totalValueINR":"253050","totalValueInUsd":"3030.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"3017730","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"WUHAN","supplierAddress":"GEDIAN ECONOMIC DEVELOPMENT DISTRCT, E-ZHOU (436070), HUBEI, CHINASDNF CHINA","customerAddress":"KENI BUILDING,"}]
      12-Jan-2022
      31-Jul-2025
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      DOSAGE - CAPSULE;ORAL - 0.5MG

      USFDA APPLICATION NUMBER - 21319

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      DOSAGE - CAPSULE;ORAL - 0.5MG;0.4MG

      USFDA APPLICATION NUMBER - 22460

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      ABOUT THIS PAGE

      Looking for 164656-23-9 / Dutasteride API manufacturers, exporters & distributors?

      Dutasteride manufacturers, exporters & distributors 1

      61

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

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

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

      API | Excipient name

      Dutasteride

      Synonyms

      164656-23-9, Avodart, Avolve, Gg-745, Gi 198745, Gi-198745

      Cas Number

      164656-23-9

      Unique Ingredient Identifier (UNII)

      O0J6XJN02I

      About Dutasteride

      A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA.

      Avodart Manufacturers

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

      Avodart Suppliers

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

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

      Avodart USDMF

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

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

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

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

      Avodart KDMF

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

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

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

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

      Avodart CEP

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

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

      Avodart WC

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

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

      Avodart 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 Avodart as an active pharmaceutical ingredient (API).

      Finished drug products

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

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

      Avodart GMP

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

      Avodart CoA

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

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

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