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01 1SIGMA TAU
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01 2PHENYLACETIC ACID
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01 1U.S.A
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01 2Inactive
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3556
Submission : 1979-06-29
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5805
Submission : 1985-04-15
Status : Inactive
Type : II
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A Phenylacetic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenylacetic Acid, including repackagers and relabelers. The FDA regulates Phenylacetic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenylacetic Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Phenylacetic Acid supplier is an individual or a company that provides Phenylacetic Acid active pharmaceutical ingredient (API) or Phenylacetic Acid finished formulations upon request. The Phenylacetic Acid suppliers may include Phenylacetic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Phenylacetic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phenylacetic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenylacetic Acid active pharmaceutical ingredient (API) in detail. Different forms of Phenylacetic Acid DMFs exist exist since differing nations have different regulations, such as Phenylacetic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phenylacetic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Phenylacetic Acid USDMF includes data on Phenylacetic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenylacetic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phenylacetic Acid suppliers with USDMF on PharmaCompass.
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