01 2Merck & Co
01 1MK -2048A DRUG PRODUCT
02 1MK-2048 DRUG SUBSTANCE
01 2U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28799
Submission : 2014-11-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28792
Submission : 2014-11-12
Status : Inactive
Type : II
A Mk2048 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mk2048, including repackagers and relabelers. The FDA regulates Mk2048 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mk2048 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Mk2048 supplier is an individual or a company that provides Mk2048 active pharmaceutical ingredient (API) or Mk2048 finished formulations upon request. The Mk2048 suppliers may include Mk2048 API manufacturers, exporters, distributors and traders.
click here to find a list of Mk2048 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mk2048 DMF (Drug Master File) is a document detailing the whole manufacturing process of Mk2048 active pharmaceutical ingredient (API) in detail. Different forms of Mk2048 DMFs exist exist since differing nations have different regulations, such as Mk2048 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mk2048 DMF submitted to regulatory agencies in the US is known as a USDMF. Mk2048 USDMF includes data on Mk2048's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mk2048 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mk2048 suppliers with USDMF on PharmaCompass.
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