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