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01 1Abbott Laboratories
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01 1VERAPAMIL AS MNFG IN N.CHICAGO, ILLINOIS
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01 1U.S.A
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01 1Inactive
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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 1394-EP2272973A1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1394-EP2272973A1, including repackagers and relabelers. The FDA regulates 1394-EP2272973A1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1394-EP2272973A1 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 1394-EP2272973A1 supplier is an individual or a company that provides 1394-EP2272973A1 active pharmaceutical ingredient (API) or 1394-EP2272973A1 finished formulations upon request. The 1394-EP2272973A1 suppliers may include 1394-EP2272973A1 API manufacturers, exporters, distributors and traders.
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A 1394-EP2272973A1 DMF (Drug Master File) is a document detailing the whole manufacturing process of 1394-EP2272973A1 active pharmaceutical ingredient (API) in detail. Different forms of 1394-EP2272973A1 DMFs exist exist since differing nations have different regulations, such as 1394-EP2272973A1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1394-EP2272973A1 DMF submitted to regulatory agencies in the US is known as a USDMF. 1394-EP2272973A1 USDMF includes data on 1394-EP2272973A1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1394-EP2272973A1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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