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PharmaCompass offers a list of Besifovir API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Besifovir manufacturer or Besifovir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Besifovir manufacturer or Besifovir supplier.
PharmaCompass also assists you with knowing the Besifovir API Price utilized in the formulation of products. Besifovir API Price is not always fixed or binding as the Besifovir Price is obtained through a variety of data sources. The Besifovir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Besifovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Besifovir, including repackagers and relabelers. The FDA regulates Besifovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Besifovir 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 Besifovir supplier is an individual or a company that provides Besifovir active pharmaceutical ingredient (API) or Besifovir finished formulations upon request. The Besifovir suppliers may include Besifovir API manufacturers, exporters, distributors and traders.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Besifovir Drug Master File in Korea (Besifovir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Besifovir. The MFDS reviews the Besifovir KDMF as part of the drug registration process and uses the information provided in the Besifovir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Besifovir 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 Besifovir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Besifovir suppliers with KDMF on PharmaCompass.
Besifovir 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 Besifovir 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 Besifovir GMP manufacturer or Besifovir GMP API supplier for your needs.
A Besifovir CoA (Certificate of Analysis) is a formal document that attests to Besifovir's compliance with Besifovir specifications and serves as a tool for batch-level quality control.
Besifovir CoA mostly includes findings from lab analyses of a specific batch. For each Besifovir 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.
Besifovir may be tested according to a variety of international standards, such as European Pharmacopoeia (Besifovir EP), Besifovir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Besifovir USP).