Synopsis
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1. 1184979-29-0
| Molecular Weight | 148.52 g/mol |
|---|---|
| Molecular Formula | C5H4ClNO2 |
| XLogP3 | -0.1 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 0 |
| Exact Mass | 148.0031206 g/mol |
| Monoisotopic Mass | 148.0031206 g/mol |
| Topological Polar Surface Area | 49.3 Ų |
| Heavy Atom Count | 9 |
| Formal Charge | 0 |
| Complexity | 207 |
| Isotope Atom Count | 3 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
ABOUT THIS PAGE
A Gimeracil-13C3 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gimeracil-13C3, including repackagers and relabelers. The FDA regulates Gimeracil-13C3 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gimeracil-13C3 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 Gimeracil-13C3 supplier is an individual or a company that provides Gimeracil-13C3 active pharmaceutical ingredient (API) or Gimeracil-13C3 finished formulations upon request. The Gimeracil-13C3 suppliers may include Gimeracil-13C3 API manufacturers, exporters, distributors and traders.
click here to find a list of Gimeracil-13C3 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 Gimeracil-13C3 Drug Master File in Japan (Gimeracil-13C3 JDMF) empowers Gimeracil-13C3 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 Gimeracil-13C3 JDMF during the approval evaluation for pharmaceutical products. At the time of Gimeracil-13C3 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 Gimeracil-13C3 suppliers with JDMF on PharmaCompass.
Gimeracil-13C3 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 Gimeracil-13C3 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 Gimeracil-13C3 GMP manufacturer or Gimeracil-13C3 GMP API supplier for your needs.
A Gimeracil-13C3 CoA (Certificate of Analysis) is a formal document that attests to Gimeracil-13C3's compliance with Gimeracil-13C3 specifications and serves as a tool for batch-level quality control.
Gimeracil-13C3 CoA mostly includes findings from lab analyses of a specific batch. For each Gimeracil-13C3 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.
Gimeracil-13C3 may be tested according to a variety of international standards, such as European Pharmacopoeia (Gimeracil-13C3 EP), Gimeracil-13C3 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gimeracil-13C3 USP).
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