Synopsis
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1. Suplatast Ion
2. Suplatast Cation
3. 94055-75-1
4. Chebi:32172
5. 4t0ho29o56
6. Sulfonium, (3-((4-(3-ethoxy-2-hydroxypropoxy)phenyl)amino)-3-oxopropyl)dimethyl-
7. Ncgc00181000-01
8. Unii-4t0ho29o56
9. Schembl1009112
10. Chembl1180156
11. Dtxsid2045074
12. Ncgc00181000-03
13. Ab01566844_01
14. Q27892871
| Molecular Weight | 328.4 g/mol |
|---|---|
| Molecular Formula | C16H26NO4S+ |
| XLogP3 | 1.3 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 10 |
| Exact Mass | 328.15825448 g/mol |
| Monoisotopic Mass | 328.15825448 g/mol |
| Topological Polar Surface Area | 68.8 Ų |
| Heavy Atom Count | 22 |
| Formal Charge | 1 |
| Complexity | 307 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
ABOUT THIS PAGE
A Suplatast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Suplatast, including repackagers and relabelers. The FDA regulates Suplatast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Suplatast API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Suplatast supplier is an individual or a company that provides Suplatast active pharmaceutical ingredient (API) or Suplatast finished formulations upon request. The Suplatast suppliers may include Suplatast API manufacturers, exporters, distributors and traders.
click here to find a list of Suplatast suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Suplatast Drug Master File in Japan (Suplatast JDMF) empowers Suplatast API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Suplatast JDMF during the approval evaluation for pharmaceutical products. At the time of Suplatast JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Suplatast suppliers with JDMF on PharmaCompass.
Suplatast 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 Suplatast 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 Suplatast GMP manufacturer or Suplatast GMP API supplier for your needs.
A Suplatast CoA (Certificate of Analysis) is a formal document that attests to Suplatast's compliance with Suplatast specifications and serves as a tool for batch-level quality control.
Suplatast CoA mostly includes findings from lab analyses of a specific batch. For each Suplatast 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.
Suplatast may be tested according to a variety of international standards, such as European Pharmacopoeia (Suplatast EP), Suplatast JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Suplatast USP).
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