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    Chemistry

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    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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    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

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    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.

    JALYN Manufacturers

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

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    JALYN Suppliers

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

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

    JALYN USDMF

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

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

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

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

    JALYN KDMF

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

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

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

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

    JALYN CEP

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

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

    JALYN WC

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

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

    JALYN 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 JALYN as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    JALYN GMP

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

    JALYN CoA

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

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

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