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01 1PENICILLIN
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5
Submission : 1940-01-01
Status : Inactive
Type : II
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A Penicillin G manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Penicillin G, including repackagers and relabelers. The FDA regulates Penicillin G manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Penicillin G 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 G manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Penicillin G supplier is an individual or a company that provides Penicillin G active pharmaceutical ingredient (API) or Penicillin G finished formulations upon request. The Penicillin G suppliers may include Penicillin G API manufacturers, exporters, distributors and traders.
click here to find a list of Penicillin G suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Penicillin G DMF (Drug Master File) is a document detailing the whole manufacturing process of Penicillin G active pharmaceutical ingredient (API) in detail. Different forms of Penicillin G DMFs exist exist since differing nations have different regulations, such as Penicillin G USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Penicillin G DMF submitted to regulatory agencies in the US is known as a USDMF. Penicillin G USDMF includes data on Penicillin G's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Penicillin G USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Penicillin G suppliers with USDMF on PharmaCompass.
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