01 1MSN Laboratories
01 1PEMIGATINIB
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-09
Pay. Date : 2024-01-04
DMF Number : 38869
Submission : 2023-11-04
Status : Active
Type : II
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PharmaCompass offers a list of Pemigatinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pemigatinib manufacturer or Pemigatinib supplier for your needs.
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A Pemigatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pemigatinib, including repackagers and relabelers. The FDA regulates Pemigatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pemigatinib 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 Pemigatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pemigatinib supplier is an individual or a company that provides Pemigatinib active pharmaceutical ingredient (API) or Pemigatinib finished formulations upon request. The Pemigatinib suppliers may include Pemigatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Pemigatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pemigatinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Pemigatinib active pharmaceutical ingredient (API) in detail. Different forms of Pemigatinib DMFs exist exist since differing nations have different regulations, such as Pemigatinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pemigatinib DMF submitted to regulatory agencies in the US is known as a USDMF. Pemigatinib USDMF includes data on Pemigatinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pemigatinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pemigatinib suppliers with USDMF on PharmaCompass.
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