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