Synopsis
Synopsis
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EU WC
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EDQM
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USP
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JP
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Europe
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1. 1-(3.alpha.-hydroxy-3.beta.-methyl-20-oxo-19-nor-5.beta.-pregnan-21-yl)-1h-pyrazole-4-carbonitrile
2. 1h-pyrazole-4-carbonitrile, 1-((3.alpha.,5.beta.)-3-hydroxy-3-methyl-20-oxo-19-norpregnan-21-yl)-
3. 3alpha-hydroxy-3beta-methyl-21-(4-cyano-1h-pyrazol-1'-yl)-19-nor-5beta-pregnan-20-one
4. 3beta-methyl-21-(4-cyano-1h-pyrazol-1'-yl)-19-norpregnanolone
5. Sage-217
1. Sage-217
2. 1632051-40-1
3. Zuranolone [inn]
4. Zuranolone [usan]
5. Sge-797
6. Chembl4105630
7. 7zw49n180b
8. S-812217
9. 1-[2-[(3r,5r,8r,9r,10s,13s,14s,17s)-3-hydroxy-3,13-dimethyl-2,4,5,6,7,8,9,10,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl]pyrazole-4-carbonitrile
10. Zuranolonesage-217
11. Zuranolone (usan/inn)
12. Unii-7zw49n180b
13. Schembl16189866
14. Dtxsid601128500
15. Glxc-15028
16. Amy27908
17. Ex-a1880
18. Bdbm50258216
19. Who 10896
20. Akos037648887
21. Db15490
22. Ac-35591
23. Bs-15950
24. Hy-103040
25. Cs-0023489
26. D11793
27. D80690
28. A905859
29. 3beta-methyl-21-(4-cyano-1h-pyrazol-1'-yl)-19-norpregnanolone
30. 3alpha-hydroxy-3beta-methyl-21-(4-cyano-1h-pyrazol-1'-yl)-19-nor-5beta-pregnan-20-one
31. 1-(2-((3r,5r,8r,9r,10s,13s,14s,17s)-3-hydroxy-3,13-dimethylhexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl)-1h-pyrazole-4-carbonitrile
32. 1-(2-((3r,5r,8r,9r,10s,13s,14s,17s)-3-hydroxy-3,13-dimethylhexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl)-1h-pyrazole-4-carbonitrile;1-[(3alpha,5beta)-3-hydroxy-3-methyl-20-oxo-19-norpregnan-21-yl]-1h-pyrazole-4-carbonitrile
33. 1-(3.alpha.-hydroxy-3.beta.-methyl-20-oxo-19-nor-5.beta.-pregnan-21-yl)-1h-pyrazole-4-carbonitrile
34. 1-(3alpha-hydroxy-3beta-methyl-20-oxo-19-nor-5beta-pregnan-21-yl)-1h-pyrazole-4-carbonitrile
35. 1h-pyrazole-4-carbonitrile, 1-((3.alpha.,5.beta.)-3-hydroxy-3-methyl-20-oxo-19-norpregnan-21-yl)-
36. 1h-pyrazole-4-carbonitrile, 1-((3alpha,5beta)-3-hydroxy-3-methyl-20-oxo-19-norpregnan-21-yl)-
Molecular Weight | 409.6 g/mol |
---|---|
Molecular Formula | C25H35N3O2 |
XLogP3 | 4.5 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 3 |
Exact Mass | 409.27292737 g/mol |
Monoisotopic Mass | 409.27292737 g/mol |
Topological Polar Surface Area | 78.9 Ų |
Heavy Atom Count | 30 |
Formal Charge | 0 |
Complexity | 746 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 8 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
NDC Package Code : 48957-0115
Start Marketing Date : 2023-10-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69988-0059
Start Marketing Date : 2023-08-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 48957-0115
Start Marketing Date : 2023-10-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69988-0059
Start Marketing Date : 2023-08-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...
About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...
About the Company : Henan Lihua Pharmaceutical Co., Ltd. is a manufacturer specializing in production of corticosteroids APIs and related intermediates. We are also classified as “Enterprises of Cl...
Details:
Zurzuvae (zuranolone), the first and only oral, once-daily, 14-day treatment course, has shown to provide rapid improvements in depressive symptoms at Day 15 and as early as Day 3 for women with PPD.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Sage Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 14, 2023
Lead Product(s) : Zuranolone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Sage Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Zurzuvae (zuranolone), the first and only oral, once-daily, 14-day treatment course, has shown to provide rapid improvements in depressive symptoms at Day 15 and as early as Day 3 for women with PPD.
Product Name : SAGE-217
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 14, 2023
Details:
Zurzuvae (zuranolone), a neuroactive steroid GABA-A receptor positive allosteric modulator, is the first and only oral, once-daily, 14-day treatment approved by FDA, that can provide rapid improvements in depressive symptoms for women with postpartum depression.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Biogen
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 31, 2023
Lead Product(s) : Zuranolone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Biogen
Deal Size : Inapplicable
Deal Type : Inapplicable
Sage Therapeutics Implements Strategic Reorganization to Support Plans for ZURZUVAE™ Commercial ...
Details : Zurzuvae (zuranolone), a neuroactive steroid GABA-A receptor positive allosteric modulator, is the first and only oral, once-daily, 14-day treatment approved by FDA, that can provide rapid improvements in depressive symptoms for women with postpartum dep...
Product Name : SAGE-217
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 31, 2023
Details:
SAGE-217 (zuranolone) is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). Currently being developed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Sage Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 03, 2023
Lead Product(s) : Zuranolone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Sage Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Sage Therapeutics and Biogen Share Update on FDA Advisory Committee for Zuranolone
Details : SAGE-217 (zuranolone) is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). Currently being developed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Product Name : SAGE-217
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 03, 2023
Details:
SAGE-217 (zuranolone) is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). Currently being developed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Biogen
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 02, 2023
Lead Product(s) : Zuranolone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Biogen
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SAGE-217 (zuranolone) is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). Currently being developed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Product Name : SAGE-217
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 02, 2023
Details:
Zurzuvae (zuranolone), a neuroactive steroid GABA-A receptor positive allosteric modulator, is the first and only oral, once-daily, 14-day treatment approved by FDA, that can provide rapid improvements in depressive symptoms for women with postpartum depression.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Sage Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 08, 2023
Lead Product(s) : Zuranolone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Sage Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with P...
Details : Zurzuvae (zuranolone), a neuroactive steroid GABA-A receptor positive allosteric modulator, is the first and only oral, once-daily, 14-day treatment approved by FDA, that can provide rapid improvements in depressive symptoms for women with postpartum dep...
Product Name : SAGE-217
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 08, 2023
Details:
Zuranolone 50 mg demonstrated a clinically meaningful and statistically significant improvement in depressive symptoms at Day 15, the primary endpoint, and at Days 3, 28, and 45, key secondary endpoints as previously reported.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Sage Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 17, 2022
Lead Product(s) : Zuranolone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Sage Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Zuranolone 50 mg demonstrated a clinically meaningful and statistically significant improvement in depressive symptoms at Day 15, the primary endpoint, and at Days 3, 28, and 45, key secondary endpoints as previously reported.
Product Name : SAGE-217
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 17, 2022
Details:
Zuranolone (SAGE-217/BIIB125) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Biogen
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 19, 2022
Lead Product(s) : Zuranolone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Biogen
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Zuranolone (SAGE-217/BIIB125) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Product Name : SAGE-217
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 19, 2022
Details:
SAGE-217 (zuranolone) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM).
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Sage Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 12, 2022
Lead Product(s) : Zuranolone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Sage Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SAGE-217 (zuranolone) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric m...
Product Name : SAGE-217
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 12, 2022
Details:
At the Day 3 primary endpoint, SAGE-217/BIIB125 (Zuranolone), investigational oral neuroactive steroid GABA-A receptor-positive allosteric modulator, 50 mg co-initiated with a standard of care antidepressant showed a statistically significant reduction in depressive symptoms.
Lead Product(s): Zuranolone,Escitalopram Oxalate
Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Biogen
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 16, 2022
Lead Product(s) : Zuranolone,Escitalopram Oxalate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Biogen
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : At the Day 3 primary endpoint, SAGE-217/BIIB125 (Zuranolone), investigational oral neuroactive steroid GABA-A receptor-positive allosteric modulator, 50 mg co-initiated with a standard of care antidepressant showed a statistically significant reduction i...
Product Name : SAGE-217
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 16, 2022
Details:
SAGE-217/BIIB125 (zuranolone) is a once-daily, two-week, investigational drug in development for treatment of major depressive disorder and postpartum depression. Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Brand Name: SAGE-217
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Biogen
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 05, 2022
Lead Product(s) : Zuranolone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Biogen
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SAGE-217/BIIB125 (zuranolone) is a once-daily, two-week, investigational drug in development for treatment of major depressive disorder and postpartum depression. Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive al...
Product Name : SAGE-217
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 05, 2022
2-Bromo-1-((3R,5R,8R,9R,10S,13S,14S,17S)-3-hydroxy...
CAS Number : 1430063-93-6
End Use API : Zuranolone
About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...
Regulatory Info : RX
Registration Country : USA
Brand Name : ZURZUVAE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2023-10-31
Application Number : 217369
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZURZUVAE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 25MG
Packaging :
Approval Date : 2023-10-31
Application Number : 217369
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZURZUVAE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date : 2023-10-31
Application Number : 217369
Regulatory Info : RX
Registration Country : USA
RLD : Yes
TE Code :
Brand Name : ZURZUVAE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG
Approval Date : 2023-10-31
Application Number : 217369
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ZURZUVAE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 25MG
Approval Date : 2023-10-31
Application Number : 217369
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ZURZUVAE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 30MG
Approval Date : 2023-10-31
Application Number : 217369
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
https://www.pharmacompass.com/pipeline-prospector-blog/indices-continue-to-climb-lilly-buys-morphic-for-us-3-2-bn-its-alzheimer-s-drug-finally-bags-fda-nod
29 Apr 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20250428466645/en/Sage-Therapeutics-Announces-First-Quarter-2025-Financial-Results-and-Highlights-Pipeline-and-Business-Updates
30 Oct 2024
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/sage-discontinues-zulresso-drops-pair-pipeline-prospects
29 Oct 2024
// BUSINESSWIRE
21 Oct 2024
// EXPRESSPHARMA
https://www.expresspharma.in/zuranolone-to-face-challenges-in-japans-mdd-market-despite-demonstrating-rapid-onset-of-action-globaldata/
26 Sep 2024
// BUSINESSWIRE
31 Jul 2024
// BUSINESSWIRE
Patents & EXCLUSIVITIES
Patent Expiration Date : 2034-04-17
US Patent Number : 10342810
Drug Substance Claim :
Drug Product Claim :
Application Number : 217369
Patent Use Code : U-2552
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-04-17
Patent Expiration Date : 2037-08-23
US Patent Number : 11236121
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 217369
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-08-23
Patent Expiration Date : 2037-08-23
US Patent Number : 11236121
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 217369
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-08-23
Patent Expiration Date : 2034-04-17
US Patent Number : 10342810
Drug Substance Claim :
Drug Product Claim :
Application Number : 217369
Patent Use Code : U-2552
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-04-17
Patent Expiration Date : 2034-04-17
US Patent Number : 9512165
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 217369
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-04-17
Patent Expiration Date : 2034-04-17
US Patent Number : 10172871
Drug Substance Claim :
Drug Product Claim :
Application Number : 217369
Patent Use Code : U-2552
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-04-17
Patent Expiration Date : 2034-04-17
US Patent Number : 10172871
Drug Substance Claim :
Drug Product Claim :
Application Number : 217369
Patent Use Code : U-2552
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-04-17
Patent Expiration Date : 2037-08-23
US Patent Number : 11884696
Drug Substance Claim :
Drug Product Claim :
Application Number : 217369
Patent Use Code : U-2552
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-08-23
Patent Expiration Date : 2034-04-17
US Patent Number : 10172871
Drug Substance Claim :
Drug Product Claim :
Application Number : 217369
Patent Use Code : U-2552
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-04-17
Patent Expiration Date : 2037-08-23
US Patent Number : 11884696
Drug Substance Claim :
Drug Product Claim :
Application Number : 217369
Patent Use Code : U-2552
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-08-23
Exclusivity Code : NCE
Exclusivity Expiration Date : 2028-10-31
Application Number : 217369
Product Number : 1
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2028-10-31
Application Number : 217369
Product Number : 2
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2028-10-31
Application Number : 217369
Product Number : 3
Exclusivity Details :
ABOUT THIS PAGE
62
PharmaCompass offers a list of Zuranolone 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 Zuranolone manufacturer or Zuranolone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zuranolone manufacturer or Zuranolone supplier.
PharmaCompass also assists you with knowing the Zuranolone API Price utilized in the formulation of products. Zuranolone API Price is not always fixed or binding as the Zuranolone Price is obtained through a variety of data sources. The Zuranolone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Zuranolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zuranolone, including repackagers and relabelers. The FDA regulates Zuranolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zuranolone 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 Zuranolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zuranolone supplier is an individual or a company that provides Zuranolone active pharmaceutical ingredient (API) or Zuranolone finished formulations upon request. The Zuranolone suppliers may include Zuranolone API manufacturers, exporters, distributors and traders.
click here to find a list of Zuranolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Zuranolone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zuranolone 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 Zuranolone 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 Zuranolone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zuranolone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zuranolone suppliers with NDC on PharmaCompass.
Zuranolone 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 Zuranolone 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 Zuranolone GMP manufacturer or Zuranolone GMP API supplier for your needs.
A Zuranolone CoA (Certificate of Analysis) is a formal document that attests to Zuranolone's compliance with Zuranolone specifications and serves as a tool for batch-level quality control.
Zuranolone CoA mostly includes findings from lab analyses of a specific batch. For each Zuranolone 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.
Zuranolone may be tested according to a variety of international standards, such as European Pharmacopoeia (Zuranolone EP), Zuranolone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zuranolone USP).