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