01 1Teva Pharmaceutical Industries
01 1FEDRATINIB HYDROCHLORIDE
01 1Israel
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-09
Pay. Date : 2023-01-31
DMF Number : 37888
Submission : 2023-03-22
Status : Active
Type : II
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.
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