01 1Merck Group
01 1EMD 121974
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14380
Submission : 1999-08-04
Status : Inactive
Type : II
A Cilengitide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cilengitide, including repackagers and relabelers. The FDA regulates Cilengitide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cilengitide 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 Cilengitide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cilengitide supplier is an individual or a company that provides Cilengitide active pharmaceutical ingredient (API) or Cilengitide finished formulations upon request. The Cilengitide suppliers may include Cilengitide API manufacturers, exporters, distributors and traders.
click here to find a list of Cilengitide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cilengitide DMF (Drug Master File) is a document detailing the whole manufacturing process of Cilengitide active pharmaceutical ingredient (API) in detail. Different forms of Cilengitide DMFs exist exist since differing nations have different regulations, such as Cilengitide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cilengitide DMF submitted to regulatory agencies in the US is known as a USDMF. Cilengitide USDMF includes data on Cilengitide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cilengitide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cilengitide suppliers with USDMF on PharmaCompass.
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