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