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