01 1Eli Lilly
01 1CEPHALEXIN HYDROCHLORIDE,BULK
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6090
Submission : 1985-11-12
Status : Inactive
Type : II
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A Palitrex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Palitrex, including repackagers and relabelers. The FDA regulates Palitrex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Palitrex 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 Palitrex supplier is an individual or a company that provides Palitrex active pharmaceutical ingredient (API) or Palitrex finished formulations upon request. The Palitrex suppliers may include Palitrex API manufacturers, exporters, distributors and traders.
click here to find a list of Palitrex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Palitrex DMF (Drug Master File) is a document detailing the whole manufacturing process of Palitrex active pharmaceutical ingredient (API) in detail. Different forms of Palitrex DMFs exist exist since differing nations have different regulations, such as Palitrex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Palitrex DMF submitted to regulatory agencies in the US is known as a USDMF. Palitrex USDMF includes data on Palitrex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Palitrex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Palitrex suppliers with USDMF on PharmaCompass.
