01 1Wyeth Pharmaceuticals Inc
02 1Blank
01 2PENICILLIN V
01 1U.S.A
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13505
Submission : 1998-09-01
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13419
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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A BRN 0096259 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BRN 0096259, including repackagers and relabelers. The FDA regulates BRN 0096259 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BRN 0096259 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 BRN 0096259 supplier is an individual or a company that provides BRN 0096259 active pharmaceutical ingredient (API) or BRN 0096259 finished formulations upon request. The BRN 0096259 suppliers may include BRN 0096259 API manufacturers, exporters, distributors and traders.
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A BRN 0096259 DMF (Drug Master File) is a document detailing the whole manufacturing process of BRN 0096259 active pharmaceutical ingredient (API) in detail. Different forms of BRN 0096259 DMFs exist exist since differing nations have different regulations, such as BRN 0096259 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BRN 0096259 DMF submitted to regulatory agencies in the US is known as a USDMF. BRN 0096259 USDMF includes data on BRN 0096259's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BRN 0096259 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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