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