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    Chemistry

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    Also known as: 98319-26-7, Proscar, Propecia, Finastid, Prostide, Chibro-proscar
    Molecular Formula
    C23H36N2O2
    Molecular Weight
    372.5  g/mol
    InChI Key
    DBEPLOCGEIEOCV-WSBQPABSSA-N
    FDA UNII
    57GNO57U7G
    Finasteride
    An orally active 3-OXO-5-ALPHA-STEROID 4-DEHYDROGENASE inhibitor. It is used as a surgical alternative for treatment of benign PROSTATIC HYPERPLASIA.
    Finasteride is a 5-alpha Reductase Inhibitor. The mechanism of action of finasteride is as a 5-alpha Reductase Inhibitor.
    1 2D Structure

    Finasteride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1S,3aS,3bS,5aR,9aR,9bS,11aS)-N-tert-butyl-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/C23H36N2O2/c1-21(2,3)25-20(27)17-8-7-15-14-6-9-18-23(5,13-11-19(26)24-18)16(14)10-12-22(15,17)4/h11,13-18H,6-10,12H2,1-5H3,(H,24,26)(H,25,27)/t14-,15-,16-,17+,18+,22-,23+/m0/s1
    2.1.3 InChI Key
    DBEPLOCGEIEOCV-WSBQPABSSA-N
    2.1.4 Canonical SMILES
    CC12CCC3C(C1CCC2C(=O)NC(C)(C)C)CCC4C3(C=CC(=O)N4)C
    2.1.5 Isomeric SMILES
    C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@H]2C(=O)NC(C)(C)C)CC[C@@H]4[C@@]3(C=CC(=O)N4)C
    2.2 Other Identifiers
    2.2.1 UNII
    57GNO57U7G
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Chibro Proscar

    2. Chibro-proscar

    3. Eucoprost

    4. Mk 906

    5. Mk-906

    6. Mk906

    7. Propecia

    8. Propeshia

    9. Proscar

    2.3.2 Depositor-Supplied Synonyms

    1. 98319-26-7

    2. Proscar

    3. Propecia

    4. Finastid

    5. Prostide

    6. Chibro-proscar

    7. Mk-906

    8. Finpecia

    9. Finasterida

    10. Finasteridum

    11. Mk 906

    12. (5alpha,17beta)-(1,1-dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide

    13. (4ar,4bs,6as,7s,9as,9bs,11ar)-n-tert-butyl-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

    14. Chembl710

    15. Nsc-741485

    16. N-tert-butyl-3-oxo-4-aza-5alpha-androst-1-ene-17beta-carboxamide

    17. 57gno57u7g

    18. Chebi:5062

    19. (1s,3as,3bs,5ar,9ar,9bs,11as)-n-tert-butyl-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide

    20. (4ar,4bs,6as,7s,9as,9bs,11ar)-n-(tert-butyl)-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

    21. Nsc-759318

    22. Finasteridum [inn-latin]

    23. Finasterida [inn-spanish]

    24. Dsstox_cid_625

    25. Dsstox_rid_75699

    26. Dsstox_gsid_20625

    27. (4ar,4bs,6as,7s,9as,9bs,11ar)-n-(1,1-dimethylethyl)-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

    28. N-tert-butyl-3-oxo-4-aza-5alpha-androst-1-en-17beta-carboxamide

    29. Andozac

    30. 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-, (5alpha,17beta)-

    31. Propecia (tn)

    32. Smr000466304

    33. Proscar (tn)

    34. Mk 0906

    35. Mk-0906

    36. Ccris 7438

    37. Hsdb 6793

    38. Mk906

    39. Sr-01000759414

    40. Brn 4269024

    41. Unii-57gno57u7g

    42. L-652,931

    43. 17beta-(n-tert-butylcarbamoyl)-4-aza-5 Alpha-androst-1-en-3-one

    44. Ncgc00016965-01

    45. Finasteride [usan:usp:inn:ban]

    46. N-(2-methyl-2-propyl)-3-oxo-4-aza-5-alpha-androst-1-ene-17-beta-carboxamide

    47. Cas-98319-26-7

    48. Mfcd00869737

    49. Ym-152

    50. Ks-1058

    51. Finasteride (proscar)

    52. Finasteride [mi]

    53. Prestwick0_000717

    54. Prestwick1_000717

    55. Prestwick2_000717

    56. Prestwick3_000717

    57. Finasteride [inn]

    58. Finasteride [jan]

    59. Finasteride [usan]

    60. Finasteride [vandf]

    61. Schembl5509

    62. Finasteride [mart.]

    63. Bspbio_000933

    64. Finasteride [who-dd]

    65. Mls000759404

    66. Mls001165768

    67. Mls001424046

    68. Finasteride (jan/usp/inn)

    69. Spbio_002854

    70. Bpbio1_001027

    71. Gtpl6818

    72. Dtxsid3020625

    73. N-tert-butyl-3-oxo-4-aza-5.alpha.-androst-1-ene-17.beta.-carboxamide

    74. Finasteride [ep Impurity]

    75. Finasteride [orange Book]

    76. 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-, (5.alpha.,17.beta.)-

    77. Bcpp000229

    78. Finasteride [ep Monograph]

    79. Finasteride [usp Impurity]

    80. Hms1570o15

    81. Hms2051f09

    82. Hms2090g22

    83. Hms2097o15

    84. Hms2235l23

    85. Hms3714o15

    86. Finasteride [usp Monograph]

    87. 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-carboxylic Acid Tert-butylamide

    88. Act02599

    89. Entadfi Component Finasteride

    90. Ex-a1951

    91. Zinc3782599

    92. Tox21_110717

    93. Tox21_201506

    94. Tox21_302744

    95. Bdbm50334788

    96. Nsc741485

    97. Nsc757443

    98. S1197

    99. Akos015894916

    100. Tox21_110717_1

    101. Bcp9000685

    102. Ccg-100937

    103. Cs-1767

    104. Db01216

    105. Finasteride Component Of Entadfi

    106. Finasteride, >=98% (hplc), Powder

    107. Nc00187

    108. Nsc 741485

    109. Nsc 759318

    110. Nsc-757443

    111. Ncgc00093560-05

    112. Ncgc00256334-01

    113. Ncgc00259057-01

    114. 140375-21-9

    115. Bf164456

    116. Cpd000466304

    117. Hy-13635

    118. Bcp0726000222

    119. Ab00513901

    120. D00321

    121. Ab00513901-07

    122. Ab00513901-08

    123. Ab00513901_09

    124. Finasteride, Vetranal(tm), Analytical Standard

    125. 319f267

    126. A845840

    127. Q424167

    128. Sr-01000759414-4

    129. Sr-01000759414-6

    130. Brd-k01095011-001-03-5

    131. Brd-k01095011-001-15-9

    132. Finasteride, British Pharmacopoeia (bp) Reference Standard

    133. Finasteride, European Pharmacopoeia (ep) Reference Standard

    134. ([1-phenyl-meth-(e)-ylidene]-amino)-aceticacidethylester

    135. (17beta-(n-tert-butylcarbamoyl)-4-aza-5alpha-androst-1-en-3-one

    136. Finasteride, United States Pharmacopeia (usp) Reference Standard

    137. (5?,17?)-n-(1,1-dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide

    138. 4-azaandrost-1-ene-17-carboxamide,1-dimethylethyl)-3-oxo-, (5.alpha., 17.beta.)-

    139. Finasteride For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    140. (1s,2r,7r,10s,11s,14s,15s)-n-tert-butyl-2,15-dimethyl-5-oxo-6-azatetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-3-ene-14-carboxamide

    141. (1s,3as,3bs,5ar,9ar,9bs,11as)-n-isobutyl-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide

    142. (1s,3as,3bs,5ar,9ar,9bs,11as)-n-isobutyl-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide;finasteride

    143. (4ar,4bs,6as,7s,9as,9bs,11ar)-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-carboxylic Acid Tert-butylamide

    144. (4ar,4bs,6as,9as,9bs,11ar)-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-carboxylic Acid Tert-butylamide

    145. (4ar,6as)-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-carboxylic Acid Tert-butylamide

    146. (4ar,6as,11ar)-4a,6a-dimethyl-2-oxo-hexadecahydro-indeno[5,4-f]quinoline-7-carboxylic Acid Tert-butylamide

    147. (4ar,6as,7s)-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-carboxylic Acid Tert-butylamide

    148. (4ar,6as,7s,11ar)-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-carboxylic Acid Tert-butylamide

    149. (r)-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-carboxylic Acid Tert-butylamide

    150. 1h-indeno[5,4-f]quinoline-7-carboxamide, N-(1,1-dimethylethyl)-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)-

    151. 4a,6a,9a-trimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-1h-indeno[5,4-f]quinoline-7-carboxylic Acid (finasteride)

    152. 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-carboxylic Acid Tert-butylamide(finasteride)

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 372.5 g/mol
    Molecular Formula C23H36N2O2
    XLogP33
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count2
    Exact Mass372.277678395 g/mol
    Monoisotopic Mass372.277678395 g/mol
    Topological Polar Surface Area58.2 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity678
    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 6  
    Drug NameFinasteride
    PubMed HealthFinasteride (By mouth)
    Drug ClassesAlopecia Agent, Benign Prostatic Hypertrophy Agent
    Drug LabelFinasteride, USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5-reductase, an intracellular enzyme that converts the androgen testosterone into 5-dihydrotestosterone (DHT).Finasteride is 4-Azaandrost-1-ene-17-car...
    Active IngredientFinasteride
    Dosage FormTablet
    Routeoral; Oral
    Strength5mg; 1mg
    Market StatusTentative Approval; Prescription
    CompanyWatson Labs; Mylan Pharms; Actavis Elizabeth; Teva; Accord Hlthcare; Hetero Labs Ltd Iii; Aurobindo Pharma; Zydus Pharms Usa; Dr Reddys Labs; Gedeon Richter Usa; Sun Pharma Global; Mylan

    2 of 6  
    Drug NamePropecia
    PubMed HealthFinasteride (By mouth)
    Drug ClassesAlopecia Agent, Benign Prostatic Hypertrophy Agent
    Drug LabelPROPECIA (finasteride) tablets contain finasteride as the active ingredient. Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5-reductase, an intracellular enzyme that converts the androgen testosterone int...
    Active IngredientFinasteride
    Dosage FormTablet
    RouteOral
    Strength1mg
    Market StatusPrescription
    CompanyMerck

    3 of 6  
    Drug NameProscar
    Drug LabelPROSCAR (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5-reductase, an intracellular enzyme that converts the androgen testosterone into 5-dihydrotestosterone (DHT).Finasteride is 4-azaandrost-1-ene-1...
    Active IngredientFinasteride
    Dosage FormTablet
    RouteOral
    Strength5mg
    Market StatusPrescription
    CompanyMerck

    4 of 6  
    Drug NameFinasteride
    PubMed HealthFinasteride (By mouth)
    Drug ClassesAlopecia Agent, Benign Prostatic Hypertrophy Agent
    Drug LabelFinasteride, USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5-reductase, an intracellular enzyme that converts the androgen testosterone into 5-dihydrotestosterone (DHT).Finasteride is 4-Azaandrost-1-ene-17-car...
    Active IngredientFinasteride
    Dosage FormTablet
    Routeoral; Oral
    Strength5mg; 1mg
    Market StatusTentative Approval; Prescription
    CompanyWatson Labs; Mylan Pharms; Actavis Elizabeth; Teva; Accord Hlthcare; Hetero Labs Ltd Iii; Aurobindo Pharma; Zydus Pharms Usa; Dr Reddys Labs; Gedeon Richter Usa; Sun Pharma Global; Mylan

    5 of 6  
    Drug NamePropecia
    PubMed HealthFinasteride (By mouth)
    Drug ClassesAlopecia Agent, Benign Prostatic Hypertrophy Agent
    Drug LabelPROPECIA (finasteride) tablets contain finasteride as the active ingredient. Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5-reductase, an intracellular enzyme that converts the androgen testosterone int...
    Active IngredientFinasteride
    Dosage FormTablet
    RouteOral
    Strength1mg
    Market StatusPrescription
    CompanyMerck

    6 of 6  
    Drug NameProscar
    Drug LabelPROSCAR (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5-reductase, an intracellular enzyme that converts the androgen testosterone into 5-dihydrotestosterone (DHT).Finasteride is 4-azaandrost-1-ene-1...
    Active IngredientFinasteride
    Dosage FormTablet
    RouteOral
    Strength5mg
    Market StatusPrescription
    CompanyMerck

    4.2 Therapeutic Uses

    Enzyme Inhibitors

    National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

    Treatment of benign prostatic hypertrophy

    Budavari, S. (ed.). The Merck Index - Encyclopedia of Chemicals, Drugs and Biologicals. Rahway, NJ: Merck and Co., Inc., 1989., p. 1250

    Antiandrogen therapy appears to produce a 30 to 40% decrease in the volume of the hyperplastic prostate after 3 to 6 months of therapy. Longer treatment may result in further prostatic regression, although this remains to be seen. Biopsy studies suggest that epithelial regression occurs to a much more significant degree than does stromal regression, but this finding may simply reflect the relatively longer turnover of the stromal cell population. The significant placebo effect of oral medication in patients with benign prostatic hyperplasia makes interpretation of clinical symptomatology and uro-flow data difficult. Analysis of symptom improvement is further complicated by the relatively slow improvement of patients on antiandrogen therapy, in contrast to surgery, in which relief is immediate. In addition to limited stromal involution and inadequate treatment duration, other biologic factors may limit the clinical efficacy of antiandrogen therapy. Most importantly, prostatic involution may not necessarily decrease urethral resistance. In addition, obstruction induced detrusor dysfunction may persist after relief of outflow obstruction in some patients, as it does after surgery. Incomplete antiandrogen action of the compounds, as well as compliance issues, may likewise limit efficacy. Although there are no data to suggest that the 5 alpha-reductase inhibitor finasteride will be more effective than other antiandrogen compounds in the treatment of benign prostatic hyperplasia, preliminary studies suggest that it has less toxicity. If long-term studies validate a modest but significant clinical response rate and preservation of sexual function, then finasteride therapy may well be acceptable to a subgroup of men presenting with the symptoms of benign prostatic hyperplasia.

    PMID:1695786 McConnell JD; Urol Clin North Am 17 (3): 661-70 (1990)

    4.3 Drug Indication

    Finasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. A combination product with [tadalafil] is also used for the symptomatic treatment of BPH for up to 26 weeks. Finasteride is also indicated for the treatment of male pattern hair loss (androgenetic alopecia, hereditary alopecia, or common male baldness) in male patients.

    Treatment of androgenetic alopecia

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Finasteride is an antiandrogenic compound that works by suppressing the production of serum and intraprostatic dihydrotestosterone (DHT) in men via inhibiting the enzyme responsible for the biosynthesis of DHT. The maximum effect of a rapid reduction in serum DHT concentration is expected to be observed 8 hours following administration of the first dose. In a single man receiving a single oral dose of 5 mg finasteride for up to 4 years, there was a reduction in the serum DHT concentrations by approximately 70% and the median circulating level of testosterone increased by approximately 10-20% within the physiologic range. In a double-blind, placebo-controlled study, finasteride reduced intraprostatic DHT level by 91.4% but finasteride is not expected to decrease the DHT levels to castrate levels since circulating testosterone is also converted to DHT by the type 1 isoenzyme expressed in other tissues. It is expected that DHT levels return to normal within 14 days upon discontinuation of the drug. In a study of male patients with benign prostatic hyperplasia prior to prostatectomy, the treatment with finasteride resulted in an approximate 80% lower DHT content was measured in prostatic tissue removed at surgery compared to placebo. While finasteride reduces the size of the prostate gland by 20%, this may not correlate well with improvement in symptoms. The effects of finasteride are reported to be more pronounced in male patients with enlarged prostates (>25 mL) who are at the greatest risk of disease progression. In phase III clinical studies, oral administration of finasteride in male patients with male pattern hair loss promoted hair growth and prevented further hair loss by 66% and 83% of the subjects, respectively, which lasted during two years' treatment. The incidences of these effects in treatment groups were significantly higher than that of the group receiving a placebo. Following finasteride administration, the levels of DHT in the scalp skin was shown to be reduced by more than 60%, indicating that the DHT found in scalp is derived from both local DHT production and circulating DHT. The effect of finasteride on scalp DHT is likely seen because of its effect on both local follicular DHT levels as well as serum DHT levels.. There is evidence from early clinical observations and controlled studies that finasteride may reduce bleeding of prostatic origin.

    5.2 MeSH Pharmacological Classification

    Urological Agents

    Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)

    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
    FINASTERIDE
    5.3.2 FDA UNII
    57GNO57U7G
    5.3.3 Pharmacological Classes
    5-alpha Reductase Inhibitors [MoA]; 5-alpha Reductase Inhibitor [EPC]
    5.4 ATC Code

    G04CB01

    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

    D - Dermatologicals

    D11 - Other dermatological preparations

    D11A - Other dermatological preparations

    D11AX - Other dermatologicals

    D11AX10 - Finasteride

    G - Genito urinary system and sex hormones

    G04 - Urologicals

    G04C - Drugs used in benign prostatic hypertrophy

    G04CB - Testosterone-5-alpha reductase inhibitors

    G04CB01 - Finasteride

    5.5 Absorption, Distribution and Excretion

    Absorption

    Finasteride is well absorbed following oral administration and displays a slow accumulation phase after multiple dosing.[lablel] In healthy male subjects receiving oral finasteride, the mean oral bioavailability was 65% for 1 mg finasteride and 63% for 5 mg finasteride, and the values ranged from 26 to 170% for 1 mg dose and from 34 to 108% for 5 mg dose, respectively. It is reported that food intake does not affect the oral bioavailability of the drug. The peak plasma concentrations (Cmax) averaged 37 ng/mL (range, 27-49 ng/mL) and was reached 1-2 hours post administration. The AUC(0-24 hr) was 53 ngxhr/mL (range, 20-154 ngxhr/mL). The plasma concentrations and AUC are reported to be higher in elderly male patients aged 70 years or older.

    Route of Elimination

    In healthy subjects, about 32-46% of total oral dose of finasteride was excreted in the urine in the form of metabolites while about 51-64% of the dose was excreted in the feces. In patients with renal impairment, the extent of urinary excretion of finasteride is expected to be decreased while the fecal excretion is increased.

    Volume of Distribution

    The volume of distribution is 76 L at steady state, ranging from 44 to 96 L. Finasteride has been shown to cross the blood brain barrier but does not appear to distribute preferentially to the CSF. It is not known whether finasteride is excreted in human milk.

    Clearance

    In healthy young subjects (n=15), the mean plasma clearance of finasteride was 165 mL/min with the range between 70 and 279 mL/min.

    5.6 Metabolism/Metabolites

    Finasteride undergoes extensive hepatic metabolism predominantly mediated by the cytochrome P450 3A4 (CYP3A4) enzyme to form the t-butyl side chain monohydroxylated and monocarboxylic acid metabolites. Theses metabolites retain less than 20% of the pharmacological activity of the parent compound.

    Finasteride has known human metabolites that include N-(1-Hydroxy-2-methylpropan-2-yl)-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide.

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

    5.7 Biological Half-Life

    In healthy young subjects receiving finasteride, the mean elimination half-life in plasma was 6 hours ranging from 3 to 16 hours. In elderly patients over the age of 70 years, the half-life is prolonged to 8 hours.

    5.8 Mechanism of Action

    Finasteride acts as a competitive and specific inhibitor of Type II 5-reductase, 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 development and 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 production of DHT together with type I 5-reductase, the type II 5-reductase isozyme is primarily found in the prostate, seminal vesicles, epididymides, and hair follicles as well as liver. Although finasteride is 100-fold more selective for type II 5-reductase than for the type I isoenzyme, chronic treatment with this drug may have some effect on type I 5-reductase, which is predominantly expressed in sebaceous glands of most regions of skin, including the scalp, and liver. It is proposed that the type I 5-reductase and type II 5-reductase is responsible for the production of one-third and two-thirds of circulating DHT, respectively. The mechanism of action of Finasteride is based on its preferential inhibition of Type II 5-reductase through the formation of a stable complex with the enzyme _in vitro_ and _in vivo_. Finasteride works selectively, where it preferentially displays a 100-fold selectivity for the human Type II 5-reductase over type I enzyme. Inhibition of Type II 5-reductase blocks the peripheral conversion of testosterone to DHT, resulting in significant decreases in serum and tissue DHT concentrations, minimal to moderate increase in serum testosterone concentrations, and substantial increases in prostatic testosterone concentrations. As DHT appears to be the principal androgen responsible for stimulation of prostatic growth, a decrease in DHT concentrations will result in a decrease in prostatic volume (approximately 20-30% after 6-24 months of continued therapy). It is suggested that increased levels of DHT can lead to potentiated transcription of prostaglandin D2, which promotes the proliferation of prostate cancer cells. In men with androgenic alopecia, the mechanism of action has not been fully determined, but finasteride has shown to decrease scalp DHT concentration to the levels found in the hairy scalp, reduce serum DHT, increase hair regrowth, and slow hair loss. Another study suggests that finasteride may work to reduce bleeding of prostatic origin by inhibiting vascular endothelial growth factor (VEGF) in the prostate, leading to atrophy and programmed cell death. This may bestow the drug therapeutic benefits in patients idiopathic prostatic bleeding, bleeding during anticoagulation, or bleeding after instrumentation.

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    Drugs in Development

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    Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions

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    Lead Product(s): Finasteride,Inapplicable

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

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    Dr. Reddy's Laboratories

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    Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions

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    Androgenic Alopecia TH07 Clinical Trial

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    Lead Product(s): Minoxidil,Finasteride,Latanoprost

    Therapeutic Area: Dermatology Brand Name: Undisclosed

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    Triple Hair

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    Androgenic Alopecia TH07 Clinical Trial

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    Study to Evaluate the Drug-drug Interaction Between IY001 and IY002 in Healthy Adult Male Subjects.

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    IY001 (Finasteride) is a Small Molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Finasteride,Tamsulosin

    Therapeutic Area: Undisclosed Brand Name: IY001

    Study Phase: Phase IProduct Type: Steroid

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    Deal Size: Inapplicable Upfront Cash: Inapplicable

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    Il-Yang Pharm

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    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

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    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Study to Evaluate the Drug-drug Interaction Between IY001 and IY002 in Healthy Adult Male Subjects...

    Details : IY001 (Finasteride) is a Small Molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of undefined medical condition.

    Product Name : IY001

    Product Type : Steroid

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    Clinical Trial of CG2001 in Chinese Adult Males with Androgenetic Alopecia

    Details:

    Minoxidil is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Alopecia.


    Lead Product(s): Minoxidil,Finasteride

    Therapeutic Area: Dermatology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 22, 2025

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    07

    Beijing Dayspring Pharmaceutical Technology Co., Ltd

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    Beijing Dayspring Pharmaceutical Technology Co., Ltd

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    Lead Product(s) : Minoxidil,Finasteride

    Therapeutic Area : Dermatology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Clinical Trial of CG2001 in Chinese Adult Males with Androgenetic Alopecia

    Details : Minoxidil is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Alopecia.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 22, 2025

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    Akums Drugs inks licensing pact with Canadian firm Triple Hair Inc

    Details:

    Akums gains rights for patented topical formulation, Therapy-07, for the Indian market which combines three medicaments (finasteride,latanoprost,minoxidil) to combat alopecia.


    Lead Product(s): Finasteride,Latanoprost,Minoxidil

    Therapeutic Area: Dermatology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Akums Drugs & Pharmaceuticals Ltd

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement October 16, 2024

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    08

    Triple Hair

    Canada
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    Triple Hair

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    Lead Product(s) : Finasteride,Latanoprost,Minoxidil

    Therapeutic Area : Dermatology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Akums Drugs & Pharmaceuticals Ltd

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Akums Drugs inks licensing pact with Canadian firm Triple Hair Inc

    Details : Akums gains rights for patented topical formulation, Therapy-07, for the Indian market which combines three medicaments (finasteride,latanoprost,minoxidil) to combat alopecia.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    October 16, 2024

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    Blue Water Biotech Acquires Proteomedix as Part of Transformation to Commercial Stage Oncology Company; Announces Name Change to Onconetix

    Details:

    The combined company will focus on the R&D and commercialization of proprietary science and technologies for therapeutics, including Entadfi, a once-daily, oral treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a PDE5 inhibitor.


    Lead Product(s): Finasteride,Tadalafil

    Therapeutic Area: Urology Brand Name: Entadfi

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Blue Water Vaccines

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Acquisition December 18, 2023

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    Onconetix

    U.S.A
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    Lead Product(s) : Finasteride,Tadalafil

    Therapeutic Area : Urology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Blue Water Vaccines

    Deal Size : Undisclosed

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Blue Water Biotech Acquires Proteomedix as Part of Transformation to Commercial Stage Oncology Com...

    Details : The combined company will focus on the R&D and commercialization of proprietary science and technologies for therapeutics, including Entadfi, a once-daily, oral treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a PDE5...

    Product Name : Entadfi

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    December 18, 2023

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    Blue Water Biotech Collaborates with IQVIA to Build Medical Sales Representative Team to Market Commercial Product Portfolio

    Details:

    Under the collaboration, Blue Water Biotech and IQVIA will market Blue Water’s commercial portfolio including, Entadfi, an FDA-approved, once daily pill that combines finasteride and tadalafil for benign prostatic hyperplasia and Zontivity (vorapaxar).


    Lead Product(s): Finasteride,Tadalafil

    Therapeutic Area: Urology Brand Name: Entadfi

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: IQVIA

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration June 21, 2023

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    10

    Blue Water Vaccines

    U.S.A
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    Blue Water Vaccines

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    Lead Product(s) : Finasteride,Tadalafil

    Therapeutic Area : Urology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : IQVIA

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Blue Water Biotech Collaborates with IQVIA to Build Medical Sales Representative Team to Market Co...

    Details : Under the collaboration, Blue Water Biotech and IQVIA will market Blue Water’s commercial portfolio including, Entadfi, an FDA-approved, once daily pill that combines finasteride and tadalafil for benign prostatic hyperplasia and Zontivity (vorapaxar).

    Product Name : Entadfi

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    June 21, 2023

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 5MG

    USFDA APPLICATION NUMBER - 20180

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    DOSAGE - TABLET;ORAL - 1MG

    USFDA APPLICATION NUMBER - 20788

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    ABOUT THIS PAGE

    Looking for 98319-26-7 / Finasteride API manufacturers, exporters & distributors?

    Finasteride manufacturers, exporters & distributors 1

    100

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

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

    API | Excipient name

    Finasteride

    Synonyms

    98319-26-7, Proscar, Propecia, Finastid, Prostide, Chibro-proscar

    Cas Number

    98319-26-7

    Unique Ingredient Identifier (UNII)

    57GNO57U7G

    About Finasteride

    An orally active 3-OXO-5-ALPHA-STEROID 4-DEHYDROGENASE inhibitor. It is used as a surgical alternative for treatment of benign PROSTATIC HYPERPLASIA.

    MSD Brand of Finasteride Manufacturers

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

    MSD Brand of Finasteride Suppliers

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

    click here to find a list of MSD Brand of Finasteride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

    MSD Brand of Finasteride USDMF

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

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

    click here to find a list of MSD Brand of Finasteride suppliers with USDMF on PharmaCompass.

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

    MSD Brand of Finasteride KDMF

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

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

    After submitting a MSD Brand of Finasteride 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 MSD Brand of Finasteride API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of MSD Brand of Finasteride suppliers with KDMF on PharmaCompass.

    MSD Brand of Finasteride CEP

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

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

    MSD Brand of Finasteride WC

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

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

    MSD Brand of Finasteride 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 MSD Brand of Finasteride as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of MSD Brand of Finasteride suppliers with NDC on PharmaCompass.

    MSD Brand of Finasteride GMP

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

    MSD Brand of Finasteride CoA

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

    MSD Brand of Finasteride CoA mostly includes findings from lab analyses of a specific batch. For each MSD Brand of Finasteride 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.

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