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