Synopsis
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1. Bms-790052
2. Bms-790052-05
3. Carbamic Acid, N,n'-((1,1'-biphenyl)-4,4'-diylbis(1h-imidazole-5,2-diyl-(2s)-2,1-pyrrolidinediyl((1s)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl)))bis-, C,c'-dimethyl Ester
4. Daclatasvir Dihydrochloride
5. Daklinza
1. 1009119-64-5
2. Daclatasvir (bms-790052)
3. Bms-790052
4. Daklinza
5. 1214735-16-6
6. Ebp 883
7. Bms790052
8. Bms 790052
9. Daclatasvir [usan]
10. Methyl N-[(2s)-1-[(2s)-2-[5-[4-[4-[2-[(2s)-1-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl]pyrrolidin-2-yl]-1h-imidazol-5-yl]phenyl]phenyl]-1h-imidazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate
11. Chebi:82977
12. Ebp-883
13. Daclatasvir (usan)
14. Carbamic Acid, N,n'-[[1,1'-biphenyl]-4,4'-diylbis[1h-imidazole-5,2-diyl-(2s)-2,1-pyrrolidinediyl[(1s)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl]]]bis-, C,c'-dimethyl Ester
15. Carbamic Acid, N,n'-((1,1'-biphenyl)-4,4'-diylbis(1h-imidazole-5,2-diyl-(2s)-2,1-pyrrolidinediyl((1s)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl)))bis-, C,c'-dimethyl Ester
16. Dimethyl ((2s,2's)-((2s,2's)-2,2'-(5,5'-([1,1'-biphenyl]-4,4'-diyl)bis(1h-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl))dica
17. 1009119-65-6
18. Li2427f9ci
19. Methyl N-[(1s)-1-[(2s)-2-[5-[4-[4-[2-[(2s)-1-[(2s)-2-(methoxycarbonylamino)-3-methyl-butanoyl]pyrrolidin-2-yl]-1h-imidazol-5-yl]phenyl]phenyl]-1h-imidazol-2-yl]pyrrolidine-1-carbonyl]-2-methyl-propyl]carbamate
20. Daclatasvir [mi]
21. Daclatasvir [inn]
22. Daclatasvir [who-dd]
23. Dimethyl (2s,2's)-1,1'-((2s,2's)-2,2'-(4,4'-(biphenyl-4,4'-diyl)bis(1h-imidazole-4,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl)dicarbamate
24. Mls006011140
25. Ebp883
26. Schembl2756027
27. Chembl2023898
28. Schembl17897804
29. Gtpl11266
30. Ex-a410
31. Dtxsid901026404
32. Amy36655
33. Dimethyl ((2s,2's)-((2s,2's)-2,2'-(5,5'-([1,1'-biphenyl]-4,4'-diyl)bis(1h-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl))dicarbamate
34. Dimethyl N,n'-(biphenyl-4,4'-diylbis{1h-imidazole-5,2-diyl-((2s)-pyrrolidine-2,1- Diyl)((1s)-1-(1-methylethyl)-2-oxoethane-2,1-diyl)})dicarbamate
35. Bdbm50387084
36. Mfcd17129086
37. S1482
38. Zinc68204830
39. Ccg-270425
40. Cs-0588
41. Db09102
42. Ncgc00346533-07
43. Ncgc00346533-09
44. Ac-28958
45. As-75298
46. Hy-10466
47. Smr004702917
48. Sw219754-1
49. D10065
50. J-520204
51. Q5207712
52. Dimethyl N,n'-((1,1'-biphenyl)-4,4'-diylbis(1h-imidazole-5,2-diyl-((2s)-pyrrolidine-2,1-diyl)((1s)-3-methyl-1-oxobutane-1,2-diyl)))dicarbamate
53. Methyl ((s)-1-((s)-2-(5-(4'-(2-((s)-1-((methoxycarbonyl)-l-valyl)pyrrolidin-2-yl)-1h-imidazol-5-yl)-[1,1'-biphenyl]-4-yl)-1h-imidazol-2-yl)pyrrolidin-1-yl)-3-methyl-1-oxobutan-2-yl)carbamate
54. Methyl [(2s)-1-{(2s)-2-[4-(4'-{2-[(2s)-1-{(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}-2-pyrrolidinyl]-1h-imidazol-4-yl}-4-biphenylyl)-1h-imidazol-2-yl]-1-pyrrolidinyl}-3-methyl-1-oxo-2-butanyl]carbamate
55. Methyl [(2s)-1-{(2s)-2-[4-(4'-{2-[(2s)-1-{(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1h-imidazol-4-yl}biphenyl-4-yl)-1h-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate
56. Methyl [(2s)-1-{(2s)-2-[5-(4'-{2-[(2s)-1-{(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1h-imidazol-5-yl}biphenyl-4-yl)-1h-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate
57. Methyl N-[(2s)-1-[(2s)-2-[5-(4'-{2-[(2s)-1-[(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]pyrrolidin-2-yl]-1h-imidazol-5-yl}-[1,1'-biphenyl]-4-yl)-1h-imidazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate
58. Methyl-n-[(2s)-1-[(2s)-2-[5-[4-[4-[2-[(2s)-1-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl] Pyrrolidin-2-yl]-1h-imidazol-5-yl]phenyl]phenyl]-1himidazol-2-yl]pyrrolidin-1-yl]3-methyl-1-oxobutan-2-yl]carbamate
Molecular Weight | 738.9 g/mol |
---|---|
Molecular Formula | C40H50N8O6 |
XLogP3 | 5.1 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 13 |
Exact Mass | 738.38533134 g/mol |
Monoisotopic Mass | 738.38533134 g/mol |
Topological Polar Surface Area | 175 Ų |
Heavy Atom Count | 54 |
Formal Charge | 0 |
Complexity | 1190 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 4 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Indicated for use with sofosbuvir, with or without ribavirin, for the treatment of chronic HCV genotype 1a/b or 3 infection. The dosing regimen of 60mg daclatasvir 60 mg with 400mg sofosbuvir once a day is recommended for both genontypes. Resistance: Reduced susceptibility to daclatasvir was associated with the polymorphisms at NS5A amino acid positions M28, Q30, L31, and Y93 in genotypes 1a, 1b, and 3a patients. NS5A Resistance Testing is recommended for HCV genotype 1a-infected patients with cirrhosis prior to the initiaition of the treatment, as the risk of resistance development is higher in genotype 1a patients.
FDA Label
Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4. 2, 4. 4 and 5. 1).
For HCV genotype specific activity, see sections 4. 4 and 5. 1.
Daclatasvir is a direct-acting antiviral agent that targets the NS5A and causes a decrease in serum HCV RNA levels. It disrupts HCV replication by specifically inhibiting the critical functions of an NS5A protein in the replication complex. It is shown to cause downregulation of the hyperphosphorylation of NS5A. It does not appear to prolong the QT interval even when given at 3 times the maximum recommended dose.
J05AP07
J - Antiinfectives for systemic use
J05 - Antivirals for systemic use
J05A - Direct acting antivirals
J05AP - Antivirals for treatment of hcv infections
J05AP07 - Daclatasvir
Absorption
Studies demonstrated that peak plasma concentrations typically occurred within 2 hours after administration of multiple oral doses ranging from 1 - 100 mg once daily. Steady state is reached after approximately 4 days of once-daily daclatasvir administration. The absolute bioavailability of the tablet formulation is 67%.
Route of Elimination
Approximately 88% of total dose of daclatasvir is eliminated into bile and feces in which 53% remains as unchanged form, while 6.6% of the total dose is eliminated primarily unchanged in the urine.
Volume of Distribution
The approximate volume of distribution of daclatasvir is 47 L in patients who was orally administered 60 mg tablet followed by 100 g [13C,15N]-daclatasvir intravenously.
Clearance
In subjects who received daclatasvir 60 mg tablet orally followed by 100 g radiolabeled daclatasvir intravenously, the total clearance was 4.2 L/h.
Daclastavir is a substrate of CYP3A enzymes where its metabolism is predominantly mediated by CYP3A4 isoform. Oxidative pathways included -oxidation of the pyrrolidine moiety, resulting in ring opening to an aminoaldehyde intermediate followed by an intramolecular reaction between the aldehyde and the proximal imidazole nitrogen atom. High proportion of the drug in the plasma (greater than 97%) is in the unchanged form.
Following multiple dose administration of daclatasvir in HCV-infected subjects, with doses ranging from 1 mg to 100 mg once daily, the terminal elimination half-life of daclatasvir ranged from approximately 12 to 15 hours.
NS5A is a viral nonstructural phospoprotein that is part of a functional replication complex in charge of viral RNA genome amplification on endoplasmic reticulum membranes. It has the ability to bind to HCV RNA. It is shown to have two distinct functions in HCV RNA replication based on phosphorylated states. Maintaining the HCV replication complex is mediated by the cis-acting function of basally phosphorylated NS5A and the trans-acting function of hyperphosphorylated NS5A modulates HCV assembly and infectious particle formation. Daclatasvir is shown to disrupt hyperphosphorylated NS5A proteins thus interfere with the function of new HCV replication complexes. It is also reported that daclatasvir also blocks both intracellular viral RNA synthesis and virion assembly/secretion in vivo.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33496
Submission : 2018-12-31
Status : Active
Type : II
NDC Package Code : 69766-063
Start Marketing Date : 2018-12-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33381
Submission : 2018-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32471
Submission : 2018-03-29
Status : Active
Type : II
Date of Issue : 2023-12-28
Valid Till : 2026-12-28
Written Confirmation Number : WC-0310
Address of the Firm :
NDC Package Code : 66039-941
Start Marketing Date : 2018-03-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-07
Pay. Date : 2016-09-28
DMF Number : 30975
Submission : 2016-10-07
Status : Active
Type : II
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0094
Start Marketing Date : 2015-07-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30737
Submission : 2016-08-11
Status : Inactive
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-08-04
Written Confirmation Number : WC-0142n
Address of the Firm :
Date of Issue : 2023-07-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0213
Address of the Firm :
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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, ...
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...
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CAS Number : 74761-42-5
End Use API : Daclatasvir
About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...
4, 4’-Bis (2-bromoacetyl) biphenyl
CAS Number : 4072-67-7
End Use API : Daclatasvir
About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...
(S)-2-((Methoxycarbonyl)amino)-3-Methylbutanoic ac...
CAS Number : 74761-42-5
End Use API : Daclatasvir
About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...
4,4'-Bis(2-bromoacetyl)biphenyl
CAS Number : 4072-67-7
End Use API : Daclatasvir
About The Company : Jiangsu Yutian Pharmaceutical Co., Ltd. is located in Dapu Pharmaceutical Zone of Lianyungang City in Jiangsu Province. It is a new and high-tech enterprise eng...
1H-Imidazole, 5,5’-[1,1’-biphenyl]-4,4’-diyl...
CAS Number : 1009119-83-8
End Use API : Daclatasvir
About The Company : Jiangsu Yutian Pharmaceutical Co., Ltd. is located in Dapu Pharmaceutical Zone of Lianyungang City in Jiangsu Province. It is a new and high-tech enterprise eng...
4,4'-Bis(2-bromoacetyl)biphenyl
CAS Number : 4072-67-7
End Use API : Daclatasvir
About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...
5,5’-[1,1’-Biphenyl]-4,4’-diylbis[2-(2S)-2- ...
CAS Number : 1009119-83-8
End Use API : Daclatasvir
About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...
Regulatory Info : DISCN
Registration Country : USA
Brand Name : DAKLINZA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 60MG BASE
Packaging :
Approval Date : 2015-07-24
Application Number : 206843
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : DAKLINZA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 90MG BASE
Packaging :
Approval Date : 2016-04-13
Application Number : 206843
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Daklinza
Dosage Form : FILM COATED PILL
Dosage Strength : 30 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Daklinza
Dosage Form : FILM COATED PILL
Dosage Strength : 60 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Daklinza
Dosage Form : Daclatasvir 30Mg 28 Combined Oral Use
Dosage Strength : 28 cpr riv 30 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Daklinza
Dosage Form : Daclatasvir 60Mg 28 Combined Oral Use
Dosage Strength : 28 cpr riv 60 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Daklinza
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 60 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Belarus
Brand Name :
Dosage Form : Tablet
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Belarus
Regulatory Info :
Registration Country : India
Brand Name : DACATEC
Dosage Form : Tablet
Dosage Strength : 60MG
Packaging : Jar pack of 30's
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 60MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Belarus
Brand Name :
Dosage Form : Tablet
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Belarus
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 60MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Belarus
Regulatory Info :
Registration Country : India
Brand Name : DACATEC
Dosage Form : Tablet
Dosage Strength : 60MG
Packaging : Jar pack of 30's
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : Jar pack of 30's
Regulatory Info :
Dosage : Tablet
Dosage Strength : 60MG
Brand Name : DACATEC
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Vietnam
Brand Name : Zacutas 90
Dosage Form : Tablet
Dosage Strength : 98.88MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Vietnam
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 98.88MG
Brand Name : Zacutas 90
Approval Date :
Application Number :
Registration Country : Vietnam
Regulatory Info :
Registration Country : Vietnam
Brand Name : Zacutas 60
Dosage Form : Tablet
Dosage Strength : 65.92MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Vietnam
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 65.92MG
Brand Name : Zacutas 60
Approval Date :
Application Number :
Registration Country : Vietnam
DRUG PRODUCT COMPOSITIONS
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Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.
Dosage Form : Cream / Lotion / Ointment, Emulsion
Grade : Topical
Category : Coating Systems & Additives, Rheology Modifiers, Topical
Application : Coating Systems & Additives, Rheology Modifiers, Topical
Excipient Details : Polyglykol 400 is a liquid PEG excipient grade product which is used as solvent, humectant, coating agent and viscosity enhancer.
Pharmacopoeia Ref : USP-NF: Polyethylene glycol 40...
Technical Specs : average molar mass 400 g/mol
Ingredient(s) : Polyethylene Glycol 400
Dosage Form : Capsule, Cream / Lotion / Ointment, Gel, Tablet
Grade : Topical and Oral
Category : Controlled & Modified Release, Topical
Brand Name : Polyethylene Glycol 400
Application : Controlled & Modified Release, Topical
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : polyethylene glycol
Brand Name : Polyethylene Glycol 400
Application : Topical
Excipient Details : A&C's Polyethylene Glycol 400 USP-NF is a short chain non-ionic surfactant.
Pharmacopoeia Ref : Not Available
Technical Specs : Low Endotoxin
Ingredient(s) : polyethylene glycol
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PharmaCompass offers a list of Daclatasvir 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 Daclatasvir manufacturer or Daclatasvir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Daclatasvir manufacturer or Daclatasvir supplier.
PharmaCompass also assists you with knowing the Daclatasvir API Price utilized in the formulation of products. Daclatasvir API Price is not always fixed or binding as the Daclatasvir Price is obtained through a variety of data sources. The Daclatasvir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Daclatasvir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daclatasvir, including repackagers and relabelers. The FDA regulates Daclatasvir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daclatasvir 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 Daclatasvir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Daclatasvir supplier is an individual or a company that provides Daclatasvir active pharmaceutical ingredient (API) or Daclatasvir finished formulations upon request. The Daclatasvir suppliers may include Daclatasvir API manufacturers, exporters, distributors and traders.
click here to find a list of Daclatasvir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Daclatasvir DMF (Drug Master File) is a document detailing the whole manufacturing process of Daclatasvir active pharmaceutical ingredient (API) in detail. Different forms of Daclatasvir DMFs exist exist since differing nations have different regulations, such as Daclatasvir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Daclatasvir DMF submitted to regulatory agencies in the US is known as a USDMF. Daclatasvir USDMF includes data on Daclatasvir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Daclatasvir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Daclatasvir suppliers with USDMF on PharmaCompass.
A Daclatasvir written confirmation (Daclatasvir WC) is an official document issued by a regulatory agency to a Daclatasvir manufacturer, verifying that the manufacturing facility of a Daclatasvir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Daclatasvir APIs or Daclatasvir finished pharmaceutical products to another nation, regulatory agencies frequently require a Daclatasvir WC (written confirmation) as part of the regulatory process.
click here to find a list of Daclatasvir suppliers with Written Confirmation (WC) on PharmaCompass.
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 Daclatasvir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Daclatasvir API and other APIs are published in this directory by the FDA.
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 Daclatasvir 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.
The NDC directory also contains data on finished compounded human drug products that contain Daclatasvir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Daclatasvir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Daclatasvir suppliers with NDC on PharmaCompass.
Daclatasvir 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 Daclatasvir 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 Daclatasvir GMP manufacturer or Daclatasvir GMP API supplier for your needs.
A Daclatasvir CoA (Certificate of Analysis) is a formal document that attests to Daclatasvir's compliance with Daclatasvir specifications and serves as a tool for batch-level quality control.
Daclatasvir CoA mostly includes findings from lab analyses of a specific batch. For each Daclatasvir 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.
Daclatasvir may be tested according to a variety of international standards, such as European Pharmacopoeia (Daclatasvir EP), Daclatasvir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Daclatasvir USP).