01 1Abbott Laboratories
01 1VERAPAMIL AS MNFG IN N.CHICAGO, ILLINOIS
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4910
Submission : 1983-03-31
Status : Inactive
Type : II
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A Isotopin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isotopin, including repackagers and relabelers. The FDA regulates Isotopin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isotopin 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 Isotopin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Isotopin supplier is an individual or a company that provides Isotopin active pharmaceutical ingredient (API) or Isotopin finished formulations upon request. The Isotopin suppliers may include Isotopin API manufacturers, exporters, distributors and traders.
click here to find a list of Isotopin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Isotopin DMF (Drug Master File) is a document detailing the whole manufacturing process of Isotopin active pharmaceutical ingredient (API) in detail. Different forms of Isotopin DMFs exist exist since differing nations have different regulations, such as Isotopin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isotopin DMF submitted to regulatory agencies in the US is known as a USDMF. Isotopin USDMF includes data on Isotopin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isotopin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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