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