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1. 2-(5,7-difluoro-1,2,3,4-tetrahydronaphthalen-3-ylamino)-n-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1h-imidazol-4-yl)pentanamide
2. Pf 03084014
3. Pf 3084014
4. Pf-03084014
5. Pf-3084014
6. Pf03084014
7. Pf3084014
1. Pf-03084014
2. 1290543-63-3
3. Pf-3084014
4. 865773-15-5
5. Pf 3084014
6. Nirogacestat [usan]
7. Pf 03084014
8. Pf3084014
9. Qz62892ofj
10. (s)-2-(((s)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-n-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1h-imidazol-4-yl)pentanamide
11. (2s)-2-[[(2s)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl]amino]-n-[1-[1-(2,2-dimethylpropylamino)-2-methylpropan-2-yl]imidazol-4-yl]pentanamide
12. Pf-03084014 (pf-3084014)
13. (s)-2-((s)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-ylamino)-n-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1h-imidazol-4-yl)pentanamide
14. Unii-qz62892ofj
15. Nirogacestat (usan/inn)
16. Nirogacestat [inn]
17. Z-3181
18. Nirogacestat [who-dd]
19. Gtpl7746
20. Chembl1770916
21. Schembl13184754
22. Dtxsid60235679
23. Ex-a855
24. Pf-3084014 (y-secratase)
25. Hms3886p21
26. Bdbm50458159
27. Mfcd19980705
28. Nsc754348
29. S8018
30. Zinc38217837
31. Akos030526383
32. Ccg-269609
33. Cs-1689
34. Db12005
35. Nsc-754348
36. Ncgc00378713-01
37. 2-(5,7-difluoro-1,2,3,4-tetrahydronaphthalen-3-ylamino)-n-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1h-imidazol-4-yl)pentanamide
38. Ac-36191
39. As-56178
40. Hy-15185
41. Pf-03084014-pf-3084014
42. A11993
43. D10960
44. F17429
45. A910640
46. Nirogacestat (pf-03084014, Pf-3084014)
47. Q27088329
48. Pf-03084014;pf-3084014;865773-15-5;
49. (2s)-2-(((2s)-6,8-difluoro-1,2,3,4-tetrahydro-2-naphthalenyl)amino)-n-(1-(2-((2,2-dimethylpropyl)amino)-1,1-dimethylethyl)-1h-imidazol-4-yl)pentanamide
50. (2s)-2-{[(2s)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl]amino}-n-(1-{1-[(2,2-dimethylpropyl)amino]-2-methylpropan-2-yl}-1h-imidazol-4-yl)pentanamide
51. Pentanamide, 2-(((2s)-6,8-difluoro-1,2,3,4-tetrahydro-2-naphthalenyl)amino)-n-(1-(2-((2,2-dimethylpropyl)amino)-1,1-dimethylethyl)-1h-imidazol-4-yl)-, (2s)-
52. Pentanamide, 2-((6,8-difluoro-1,2,3,4-tetrahydro-2-naphthalenyl)amino)-n-(1-(2-((2,2-dimethylpropyl)amino)-1,1-dimethylethyl)-1h-imidazol-4-yl)-, (2s)-
53. Pentanamide, 2-[(6,8-difluoro-1,2,3,4-tetrahydro-2-naphthalenyl)amino]-n-[1-[2-[(2,2-dimethylpropyl)amino]-1,1-dimethylethyl]-1h-imidazol-4-yl]-, (2s)
Molecular Weight | 489.6 g/mol |
---|---|
Molecular Formula | C27H41F2N5O |
XLogP3 | 4.8 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 11 |
Exact Mass | 489.32791727 g/mol |
Monoisotopic Mass | 489.32791727 g/mol |
Topological Polar Surface Area | 71 Ų |
Heavy Atom Count | 35 |
Formal Charge | 0 |
Complexity | 685 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Gamma Secretase Inhibitors and Modulators
Agents that suppress GAMMA-SECRETASE by inhibiting or modulating its activities. Targeted enzymatic activities include its involvement in accumulation of toxic AMYLOID BETA-PEPTIDES (e.g., Aβ42) in ALZHEIMER DISEASE and activation of NOTCH RECEPTOR mediated SIGNAL PATHWAYS in certain cancer types. (See all compounds classified as Gamma Secretase Inhibitors and Modulators.)
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Date of Issue : 2022-06-24
Valid Till : 2025-07-14
Written Confirmation Number : WC-0130
Address of the Firm :
Date of Issue : 2022-06-24
Valid Till : 2025-07-14
Written Confirmation Number : WC-0130
Address of the Firm : Plot No. 79B, 80A, 80B, 81A, & 82, Kolhar Industrial Area, Bidar, Karnataka -585...
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...
Details:
Ogsiveo (nirogacestat) is a USFDA approved oral, selective, small molecule gamma secretase inhibitor. It is being evaluated for the treatment of adults with desmoid tumors.
Lead Product(s): Nirogacestat Hydrobromide
Therapeutic Area: Oncology Brand Name: Ogsiveo
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 29, 2024
Lead Product(s) : Nirogacestat Hydrobromide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
SpringWorks Announces EMA Validation for Nirogacestat in Adults with Desmoid Tumors
Details : Ogsiveo (nirogacestat) is a USFDA approved oral, selective, small molecule gamma secretase inhibitor. It is being evaluated for the treatment of adults with desmoid tumors.
Product Name : Ogsiveo
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 29, 2024
Details:
Ogsiveo (nirogacestat) is an investigational gamma secretase inhibitor which is approved by USFDA as the first and only treatment for adults with desmoid tumors.
Lead Product(s): Nirogacestat Hydrobromide
Therapeutic Area: Oncology Brand Name: Ogsiveo
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 27, 2023
Lead Product(s) : Nirogacestat Hydrobromide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors
Details : Ogsiveo (nirogacestat) is an investigational gamma secretase inhibitor which is approved by USFDA as the first and only treatment for adults with desmoid tumors.
Product Name : Ogsiveo
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 27, 2023
Details:
Ogsiveo (nirogacestat) is an investigational gamma secretase inhibitor which is approved by USFDA as the first and only treatment for adults with desmoid tumors.
Lead Product(s): Nirogacestat Hydrobromide
Therapeutic Area: Oncology Brand Name: Ogsiveo
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 27, 2023
Lead Product(s) : Nirogacestat Hydrobromide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ogsiveo (nirogacestat) is an investigational gamma secretase inhibitor which is approved by USFDA as the first and only treatment for adults with desmoid tumors.
Product Name : Ogsiveo
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 27, 2023
Details:
The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development activities.
Lead Product(s): Nirogacestat Hydrobromide
Therapeutic Area: Oncology Brand Name: Ogsiveo
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Goldman Sachs & Co
Deal Size: $316.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 12, 2023
Lead Product(s) : Nirogacestat Hydrobromide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Goldman Sachs & Co
Deal Size : $316.2 million
Deal Type : Public Offering
Details : The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development ...
Product Name : Ogsiveo
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
August 12, 2023
Details:
PF-03084014 (nirogacestat) is an investigational gamma secretase inhibitor being develop in patients with recurrent ovarian granulosa cell tumors (OvGCT).
Lead Product(s): Nirogacestat Hydrobromide
Therapeutic Area: Oncology Brand Name: Ogsiveo
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 30, 2023
Lead Product(s) : Nirogacestat Hydrobromide
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : PF-03084014 (nirogacestat) is an investigational gamma secretase inhibitor being develop in patients with recurrent ovarian granulosa cell tumors (OvGCT).
Product Name : Ogsiveo
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 30, 2023
Details:
The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development activities.
Lead Product(s): Nirogacestat Hydrobromide
Therapeutic Area: Oncology Brand Name: Ogsiveo
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Goldman Sachs & Co
Deal Size: $275.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering May 12, 2023
Lead Product(s) : Nirogacestat Hydrobromide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Goldman Sachs & Co
Deal Size : $275.0 million
Deal Type : Public Offering
SpringWorks Therapeutics Announces Pricing of Upsized Public Offering of Common Stock
Details : The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development ...
Product Name : Ogsiveo
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
May 12, 2023
Details:
PF-03084014 (nirogacestat) is an investigational gamma secretase inhibitor being develop in patients with treatment of adults with desmoid tumors. PDUFA date has been extended by the standard extension period of three months.
Lead Product(s): Nirogacestat Hydrobromide
Therapeutic Area: Oncology Brand Name: Ogsiveo
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 06, 2023
Lead Product(s) : Nirogacestat Hydrobromide
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
SpringWorks Therapeutics Announces PDUFA Date Extension for Nirogacestat NDA
Details : PF-03084014 (nirogacestat) is an investigational gamma secretase inhibitor being develop in patients with treatment of adults with desmoid tumors. PDUFA date has been extended by the standard extension period of three months.
Product Name : Ogsiveo
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 06, 2023
Details:
The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development activities.
Lead Product(s): Nirogacestat Hydrobromide
Therapeutic Area: Oncology Brand Name: Ogsiveo
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Goldman Sachs & Co
Deal Size: $287.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 12, 2023
Lead Product(s) : Nirogacestat Hydrobromide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Goldman Sachs & Co
Deal Size : $287.5 million
Deal Type : Public Offering
SpringWorks Therapeutics Announces Proposed Public Offering of Common Stock
Details : The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development ...
Product Name : Ogsiveo
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
April 12, 2023
Details:
PF-03084014 (nirogacestat) is an oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors and in Phase 2 clinical development for ovarian granulosa cell tumors.
Lead Product(s): Nirogacestat Hydrobromide
Therapeutic Area: Oncology Brand Name: Ogsiveo
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 27, 2023
Lead Product(s) : Nirogacestat Hydrobromide
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : PF-03084014 (nirogacestat) is an oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors and in Phase 2 clinical development for ovarian granulosa cell tumors.
Product Name : Ogsiveo
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 27, 2023
Details:
PF-03084014 (nirogacestat) is an oral, selective, small molecule gamma secretase inhibitor in phase 3 clinical development for desmoid tumors and in phase 2 clinical development for ovarian granulosa cell tumors.
Lead Product(s): Nirogacestat Hydrobromide
Therapeutic Area: Oncology Brand Name: Ogsiveo
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 27, 2022
Lead Product(s) : Nirogacestat Hydrobromide
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : PF-03084014 (nirogacestat) is an oral, selective, small molecule gamma secretase inhibitor in phase 3 clinical development for desmoid tumors and in phase 2 clinical development for ovarian granulosa cell tumors.
Product Name : Ogsiveo
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 27, 2022
Regulatory Info : RX
Registration Country : USA
Brand Name : OGSIVEO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG BASE
Packaging :
Approval Date : 2023-11-27
Application Number : 217677
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OGSIVEO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2024-04-04
Application Number : 217677
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OGSIVEO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date : 2024-04-04
Application Number : 217677
Regulatory Info : RX
Registration Country : USA
RLD : Yes
TE Code :
Brand Name : OGSIVEO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG BASE
Approval Date : 2023-11-27
Application Number : 217677
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OGSIVEO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date : 2024-04-04
Application Number : 217677
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OGSIVEO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date : 2024-04-04
Application Number : 217677
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Market Place
Patents & EXCLUSIVITIES
Patent Expiration Date : 2025-08-18
US Patent Number : 7795447
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 217677
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-08-18
Patent Expiration Date : 2043-05-19
US Patent Number : 12011434
Drug Substance Claim :
Drug Product Claim :
Application Number : 217677
Patent Use Code : U-3754
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2043-05-19
Patent Expiration Date : 2039-08-09
US Patent Number : 10941118
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 217677
Patent Use Code : U-3754
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-08-09
Patent Expiration Date : 2039-08-09
US Patent Number : 11845732
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 217677
Patent Use Code : U-3754
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-08-09
Patent Expiration Date : 2039-08-09
US Patent Number : 11845732
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 217677
Patent Use Code : U-3754
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-08-09
Patent Expiration Date : 2025-08-18
US Patent Number : 7342118
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 217677
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-08-18
Patent Expiration Date : 2043-05-19
US Patent Number : 11925619
Drug Substance Claim :
Drug Product Claim :
Application Number : 217677
Patent Use Code : U-3754
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2043-05-19
Patent Expiration Date : 2042-07-08
US Patent Number : 11504354
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217677
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2042-07-08
Patent Expiration Date : 2042-07-08
US Patent Number : 12247012
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217677
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2042-07-08
Patent Expiration Date : 2025-08-18
US Patent Number : 7342118
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 217677
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-08-18
ABOUT THIS PAGE
49
PharmaCompass offers a list of Nirogacestat 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 Nirogacestat manufacturer or Nirogacestat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nirogacestat manufacturer or Nirogacestat supplier.
PharmaCompass also assists you with knowing the Nirogacestat API Price utilized in the formulation of products. Nirogacestat API Price is not always fixed or binding as the Nirogacestat Price is obtained through a variety of data sources. The Nirogacestat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nirogacestat Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nirogacestat Hydrobromide, including repackagers and relabelers. The FDA regulates Nirogacestat Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nirogacestat Hydrobromide 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 Nirogacestat Hydrobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nirogacestat Hydrobromide supplier is an individual or a company that provides Nirogacestat Hydrobromide active pharmaceutical ingredient (API) or Nirogacestat Hydrobromide finished formulations upon request. The Nirogacestat Hydrobromide suppliers may include Nirogacestat Hydrobromide API manufacturers, exporters, distributors and traders.
click here to find a list of Nirogacestat Hydrobromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nirogacestat Hydrobromide written confirmation (Nirogacestat Hydrobromide WC) is an official document issued by a regulatory agency to a Nirogacestat Hydrobromide manufacturer, verifying that the manufacturing facility of a Nirogacestat Hydrobromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nirogacestat Hydrobromide APIs or Nirogacestat Hydrobromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Nirogacestat Hydrobromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Nirogacestat Hydrobromide suppliers with Written Confirmation (WC) on PharmaCompass.
Nirogacestat Hydrobromide 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 Nirogacestat Hydrobromide 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 Nirogacestat Hydrobromide GMP manufacturer or Nirogacestat Hydrobromide GMP API supplier for your needs.
A Nirogacestat Hydrobromide CoA (Certificate of Analysis) is a formal document that attests to Nirogacestat Hydrobromide's compliance with Nirogacestat Hydrobromide specifications and serves as a tool for batch-level quality control.
Nirogacestat Hydrobromide CoA mostly includes findings from lab analyses of a specific batch. For each Nirogacestat Hydrobromide 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.
Nirogacestat Hydrobromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Nirogacestat Hydrobromide EP), Nirogacestat Hydrobromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nirogacestat Hydrobromide USP).