01 1Synthelabo Tanabe Chimie
01 1ALPIDEM
01 1France
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9496
Submission : 1992-01-10
Status : Inactive
Type : II
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PharmaCompass offers a list of Alpidem 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 Alpidem manufacturer or Alpidem supplier for your needs.
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A ALPIDEM [MI] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ALPIDEM [MI], including repackagers and relabelers. The FDA regulates ALPIDEM [MI] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ALPIDEM [MI] 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 ALPIDEM [MI] supplier is an individual or a company that provides ALPIDEM [MI] active pharmaceutical ingredient (API) or ALPIDEM [MI] finished formulations upon request. The ALPIDEM [MI] suppliers may include ALPIDEM [MI] API manufacturers, exporters, distributors and traders.
click here to find a list of ALPIDEM [MI] suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A ALPIDEM [MI] DMF (Drug Master File) is a document detailing the whole manufacturing process of ALPIDEM [MI] active pharmaceutical ingredient (API) in detail. Different forms of ALPIDEM [MI] DMFs exist exist since differing nations have different regulations, such as ALPIDEM [MI] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ALPIDEM [MI] DMF submitted to regulatory agencies in the US is known as a USDMF. ALPIDEM [MI] USDMF includes data on ALPIDEM [MI]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ALPIDEM [MI] USDMF is kept confidential to protect the manufacturer’s intellectual property.
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