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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alpidem manufacturer or Alpidem supplier.
A Alpidem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alpidem, including repackagers and relabelers. The FDA regulates Alpidem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alpidem 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 supplier is an individual or a company that provides Alpidem active pharmaceutical ingredient (API) or Alpidem finished formulations upon request. The Alpidem suppliers may include Alpidem API manufacturers, exporters, distributors and traders.
click here to find a list of Alpidem suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Alpidem DMF (Drug Master File) is a document detailing the whole manufacturing process of Alpidem active pharmaceutical ingredient (API) in detail. Different forms of Alpidem DMFs exist exist since differing nations have different regulations, such as Alpidem USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alpidem DMF submitted to regulatory agencies in the US is known as a USDMF. Alpidem USDMF includes data on Alpidem's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alpidem USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alpidem suppliers with USDMF on PharmaCompass.
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