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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
Market Place
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
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, COA and API Price 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, COA and API Price 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.
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, API price, 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).
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