01 1MSN Laboratories
01 1SELPERCATINIB
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-09
Pay. Date : 2023-09-27
DMF Number : 38833
Submission : 2023-09-27
Status : Active
Type : II
A Selpercatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Selpercatinib, including repackagers and relabelers. The FDA regulates Selpercatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Selpercatinib 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 Selpercatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Selpercatinib supplier is an individual or a company that provides Selpercatinib active pharmaceutical ingredient (API) or Selpercatinib finished formulations upon request. The Selpercatinib suppliers may include Selpercatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Selpercatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Selpercatinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Selpercatinib active pharmaceutical ingredient (API) in detail. Different forms of Selpercatinib DMFs exist exist since differing nations have different regulations, such as Selpercatinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Selpercatinib DMF submitted to regulatory agencies in the US is known as a USDMF. Selpercatinib USDMF includes data on Selpercatinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Selpercatinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Selpercatinib suppliers with USDMF on PharmaCompass.
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