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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 |
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ABOUT THIS PAGE
A Mirogabalin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirogabalin, including repackagers and relabelers. The FDA regulates Mirogabalin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirogabalin 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mirogabalin supplier is an individual or a company that provides Mirogabalin active pharmaceutical ingredient (API) or Mirogabalin finished formulations upon request. The Mirogabalin suppliers may include Mirogabalin API manufacturers, exporters, distributors and traders.
click here to find a list of Mirogabalin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mirogabalin DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirogabalin active pharmaceutical ingredient (API) in detail. Different forms of Mirogabalin DMFs exist exist since differing nations have different regulations, such as Mirogabalin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirogabalin DMF submitted to regulatory agencies in the US is known as a USDMF. Mirogabalin USDMF includes data on Mirogabalin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirogabalin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mirogabalin 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 Drug Master File in Korea (Mirogabalin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mirogabalin. The MFDS reviews the Mirogabalin KDMF as part of the drug registration process and uses the information provided in the Mirogabalin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mirogabalin 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mirogabalin suppliers with KDMF on PharmaCompass.
Mirogabalin 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 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 GMP manufacturer or Mirogabalin GMP API supplier for your needs.
A Mirogabalin CoA (Certificate of Analysis) is a formal document that attests to Mirogabalin's compliance with Mirogabalin specifications and serves as a tool for batch-level quality control.
Mirogabalin CoA mostly includes findings from lab analyses of a specific batch. For each Mirogabalin 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Mirogabalin EP), Mirogabalin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mirogabalin USP).
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