Synopsis
Synopsis
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CEP/COS
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JDMF
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EU WC
0
KDMF
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VMF
0
EDQM
0
USP
0
JP
0
Others
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Europe
0
Canada
0
Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
US Medicaid
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Annual Reports
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Regulatory FDF Prices
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FDF
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Stock Recap #PipelineProspector


1. 1628106-94-4
2. Sofpironium (bromide)
3. Bbi-4000
4. Sofpironium Bromide [usan]
5. 7b2y1932xu
6. (3r)-3-((r)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1-(2-ethoxy-2-oxoethyl)-1-methylpyrrolidin-1-ium Bromide
7. Pyrrolidinium, 3-(((2r)-2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy)-1-(2-ethoxy-2-oxoethyl)-1-methyl-, Bromide (1:1), (3r)-
8. Starbld0007908
9. Unii-7b2y1932xu
10. Chembl3707223
11. Schembl20995843
12. Sofpironium Bromide [inn]
13. Sofpironium Bromide [jan]
14. Ex-a5238
15. Sofpironium Bromide [who-dd]
16. Sofpironium Bromide (jan/usan/inn)
17. Hy-109013
18. Cs-0030511
19. D10989
20. Q27268000
21. 1-ambo-(3r)-3-(((r)-(cyclopentyl)hydroxy(phenyl) Acetyl)oxy)-1-(2-ethoxy-2-oxoethyl)-1-methylpyrrolidinium Bromide Anticholinergic
| Molecular Weight | 470.4 g/mol |
|---|---|
| Molecular Formula | C22H32BrNO5 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 9 |
| Exact Mass | 469.14639 g/mol |
| Monoisotopic Mass | 469.14639 g/mol |
| Topological Polar Surface Area | 72.8 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 555 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31310
Submission : 2017-09-22
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 68259-1318
Start Marketing Date : 2024-12-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...
About the Company : Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of ...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
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23 Jan 2026
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23 Jan 2023
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01 Aug 2022
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14 Feb 2022
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2034-03-14
US Patent Number : 9492429
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217347
Patent Use Code : U-2398
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-03-14

Patent Expiration Date : 2034-05-22
US Patent Number : 11034652
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217347
Patent Use Code : U-2398
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-05-22

Patent Expiration Date : 2034-03-14
US Patent Number : 9895350
Drug Substance Claim :
Drug Product Claim :
Application Number : 217347
Patent Use Code : U-2398
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-03-14

Patent Expiration Date : 2034-05-22
US Patent Number : 11026919
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217347
Patent Use Code : U-2398
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-05-22

Patent Expiration Date : 2034-05-22
US Patent Number : 10952990
Drug Substance Claim :
Drug Product Claim :
Application Number : 217347
Patent Use Code : U-2398
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-05-22

Patent Expiration Date : 2037-07-20
US Patent Number : 11123325
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217347
Patent Use Code : U-2398
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-07-20

Patent Expiration Date : 2040-05-22
US Patent Number : 11566000
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 217347
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-05-22

Patent Expiration Date : 2034-05-22
US Patent Number : 10947192
Drug Substance Claim :
Drug Product Claim :
Application Number : 217347
Patent Use Code : U-2398
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-05-22

Patent Expiration Date : 2034-05-22
US Patent Number : 11084788
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217347
Patent Use Code : U-2398
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-05-22

Patent Expiration Date : 2034-03-14
US Patent Number : 10383846
Drug Substance Claim :
Drug Product Claim :
Application Number : 217347
Patent Use Code : U-2398
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-03-14

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Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Exclusivity Code : NCE
Exclusivity Expiration Date : 2029-06-20
Application Number : 217347
Product Number : 1
Exclusivity Details :

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
89
PharmaCompass offers a list of Sofpironium Bromide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sofpironium Bromide manufacturer or Sofpironium Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sofpironium Bromide manufacturer or Sofpironium Bromide supplier.
A Sofpironium Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sofpironium Bromide, including repackagers and relabelers. The FDA regulates Sofpironium Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sofpironium Bromide 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 Sofpironium Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sofpironium Bromide supplier is an individual or a company that provides Sofpironium Bromide active pharmaceutical ingredient (API) or Sofpironium Bromide finished formulations upon request. The Sofpironium Bromide suppliers may include Sofpironium Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Sofpironium Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sofpironium Bromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Sofpironium Bromide active pharmaceutical ingredient (API) in detail. Different forms of Sofpironium Bromide DMFs exist exist since differing nations have different regulations, such as Sofpironium Bromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sofpironium Bromide DMF submitted to regulatory agencies in the US is known as a USDMF. Sofpironium Bromide USDMF includes data on Sofpironium Bromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sofpironium Bromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sofpironium Bromide suppliers with USDMF 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 Sofpironium Bromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sofpironium Bromide 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 Sofpironium Bromide 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 Sofpironium Bromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sofpironium Bromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sofpironium Bromide suppliers with NDC on PharmaCompass.
Sofpironium Bromide 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 Sofpironium Bromide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sofpironium Bromide GMP manufacturer or Sofpironium Bromide GMP API supplier for your needs.
A Sofpironium Bromide CoA (Certificate of Analysis) is a formal document that attests to Sofpironium Bromide's compliance with Sofpironium Bromide specifications and serves as a tool for batch-level quality control.
Sofpironium Bromide CoA mostly includes findings from lab analyses of a specific batch. For each Sofpironium Bromide 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.
Sofpironium Bromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Sofpironium Bromide EP), Sofpironium Bromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sofpironium Bromide USP).