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1. 1138245-21-2
2. Mirogabalin Besilate
3. Mirogabalin Besylate [usan]
4. 01f4frp8yl
5. 2-[(1r,5s,6s)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic Acid;benzenesulfonic Acid
6. Mirogabalin Besilate (jan)
7. Mirogabalin Besylate (usan)
8. 2-((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl)acetic Acid Compound With Benzenesulfonic Acid (1:1)
9. Bicyclo(3.2.0)hept-3-ene-6-acetic Acid, 6-(aminomethyl)-3-ethyl-, (1r,5s,6s)-, Benzenesulfonate (1:1)
10. Mirogabalin Besilate [jan]
11. Unii-01f4frp8yl
12. Mirogabalin Besilate [who-dd]
13. Schembl1883872
14. Chembl3545257
15. Amy16760
16. Ex-a2817
17. Mfcd31631215
18. Ac-30336
19. Hy-108006
20. Cs-0027136
21. D10790
22. A901402
23. 2-((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl)acetic Acid Besylate
24. 2-((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl)aceticacidbesylate
25. ((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo(3.2.0)hept-3-en-6-yl)acetic Acid Monobenzenesulfonate
26. [(1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl]acetic Acid Benzenesulfonate;
Molecular Weight | 367.5 g/mol |
---|---|
Molecular Formula | C18H25NO5S |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 5 |
Exact Mass | 367.14534407 g/mol |
Monoisotopic Mass | 367.14534407 g/mol |
Topological Polar Surface Area | 126 Ų |
Heavy Atom Count | 25 |
Formal Charge | 0 |
Complexity | 494 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39342
Submission : 2023-12-29
Status : Active
Type : II
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38908
Submission : 2023-09-20
Status : Active
Type : II
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-07-17
Registration Number : Thu21-27-ND(1)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No.10/G-1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, 502319, India
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ABOUT THIS PAGE
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PharmaCompass offers a list of Mirogabalin Besilate 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 Mirogabalin Besilate manufacturer or Mirogabalin Besilate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mirogabalin Besilate manufacturer or Mirogabalin Besilate supplier.
PharmaCompass also assists you with knowing the Mirogabalin Besilate API Price utilized in the formulation of products. Mirogabalin Besilate API Price is not always fixed or binding as the Mirogabalin Besilate Price is obtained through a variety of data sources. The Mirogabalin Besilate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mirogabalin Besilate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirogabalin Besilate, including repackagers and relabelers. The FDA regulates Mirogabalin Besilate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirogabalin Besilate 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 Mirogabalin Besilate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mirogabalin Besilate supplier is an individual or a company that provides Mirogabalin Besilate active pharmaceutical ingredient (API) or Mirogabalin Besilate finished formulations upon request. The Mirogabalin Besilate suppliers may include Mirogabalin Besilate API manufacturers, exporters, distributors and traders.
click here to find a list of Mirogabalin Besilate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mirogabalin Besilate DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirogabalin Besilate active pharmaceutical ingredient (API) in detail. Different forms of Mirogabalin Besilate DMFs exist exist since differing nations have different regulations, such as Mirogabalin Besilate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirogabalin Besilate DMF submitted to regulatory agencies in the US is known as a USDMF. Mirogabalin Besilate USDMF includes data on Mirogabalin Besilate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirogabalin Besilate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mirogabalin Besilate suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Mirogabalin Besilate Drug Master File in Korea (Mirogabalin Besilate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mirogabalin Besilate. The MFDS reviews the Mirogabalin Besilate KDMF as part of the drug registration process and uses the information provided in the Mirogabalin Besilate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mirogabalin Besilate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Mirogabalin Besilate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mirogabalin Besilate suppliers with KDMF on PharmaCompass.
Mirogabalin Besilate 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 Mirogabalin Besilate 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 Mirogabalin Besilate GMP manufacturer or Mirogabalin Besilate GMP API supplier for your needs.
A Mirogabalin Besilate CoA (Certificate of Analysis) is a formal document that attests to Mirogabalin Besilate's compliance with Mirogabalin Besilate specifications and serves as a tool for batch-level quality control.
Mirogabalin Besilate CoA mostly includes findings from lab analyses of a specific batch. For each Mirogabalin Besilate 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.
Mirogabalin Besilate may be tested according to a variety of international standards, such as European Pharmacopoeia (Mirogabalin Besilate EP), Mirogabalin Besilate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mirogabalin Besilate USP).