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ABOUT THIS PAGE
A Tofisopam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tofisopam, including repackagers and relabelers. The FDA regulates Tofisopam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tofisopam 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 Tofisopam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tofisopam supplier is an individual or a company that provides Tofisopam active pharmaceutical ingredient (API) or Tofisopam finished formulations upon request. The Tofisopam suppliers may include Tofisopam API manufacturers, exporters, distributors and traders.
click here to find a list of Tofisopam 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 Tofisopam Drug Master File in Japan (Tofisopam JDMF) empowers Tofisopam 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 Tofisopam JDMF during the approval evaluation for pharmaceutical products. At the time of Tofisopam 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 Tofisopam suppliers with JDMF 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 Tofisopam Drug Master File in Korea (Tofisopam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tofisopam. The MFDS reviews the Tofisopam KDMF as part of the drug registration process and uses the information provided in the Tofisopam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tofisopam 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 Tofisopam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tofisopam suppliers with KDMF on PharmaCompass.
A Tofisopam written confirmation (Tofisopam WC) is an official document issued by a regulatory agency to a Tofisopam manufacturer, verifying that the manufacturing facility of a Tofisopam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tofisopam APIs or Tofisopam finished pharmaceutical products to another nation, regulatory agencies frequently require a Tofisopam WC (written confirmation) as part of the regulatory process.
click here to find a list of Tofisopam suppliers with Written Confirmation (WC) on PharmaCompass.
Tofisopam 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 Tofisopam 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 Tofisopam GMP manufacturer or Tofisopam GMP API supplier for your needs.
A Tofisopam CoA (Certificate of Analysis) is a formal document that attests to Tofisopam's compliance with Tofisopam specifications and serves as a tool for batch-level quality control.
Tofisopam CoA mostly includes findings from lab analyses of a specific batch. For each Tofisopam 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.
Tofisopam may be tested according to a variety of international standards, such as European Pharmacopoeia (Tofisopam EP), Tofisopam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tofisopam USP).
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