01 1Bayer AG
01 1BAY Y 3118 DRUG SUBSTANCE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9861
Submission : 1992-09-08
Status : Inactive
Type : II
A Bay Y3118 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bay Y3118, including repackagers and relabelers. The FDA regulates Bay Y3118 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bay Y3118 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 Bay Y3118 supplier is an individual or a company that provides Bay Y3118 active pharmaceutical ingredient (API) or Bay Y3118 finished formulations upon request. The Bay Y3118 suppliers may include Bay Y3118 API manufacturers, exporters, distributors and traders.
click here to find a list of Bay Y3118 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bay Y3118 DMF (Drug Master File) is a document detailing the whole manufacturing process of Bay Y3118 active pharmaceutical ingredient (API) in detail. Different forms of Bay Y3118 DMFs exist exist since differing nations have different regulations, such as Bay Y3118 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bay Y3118 DMF submitted to regulatory agencies in the US is known as a USDMF. Bay Y3118 USDMF includes data on Bay Y3118's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bay Y3118 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bay Y3118 suppliers with USDMF on PharmaCompass.
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