01 1Roche Diagnostics GmbH
02 1SIGMA TAU
01 2D-PHENYLALANINE
01 1Germany
02 1U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4966
Submission : 1983-03-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2570
Submission : 1975-07-21
Status : Inactive
Type : II
A D-Phenylalanine API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D-Phenylalanine API, including repackagers and relabelers. The FDA regulates D-Phenylalanine API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D-Phenylalanine API 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 D-Phenylalanine API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A D-Phenylalanine API supplier is an individual or a company that provides D-Phenylalanine API active pharmaceutical ingredient (API) or D-Phenylalanine API finished formulations upon request. The D-Phenylalanine API suppliers may include D-Phenylalanine API API manufacturers, exporters, distributors and traders.
click here to find a list of D-Phenylalanine API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A D-Phenylalanine API DMF (Drug Master File) is a document detailing the whole manufacturing process of D-Phenylalanine API active pharmaceutical ingredient (API) in detail. Different forms of D-Phenylalanine API DMFs exist exist since differing nations have different regulations, such as D-Phenylalanine API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A D-Phenylalanine API DMF submitted to regulatory agencies in the US is known as a USDMF. D-Phenylalanine API USDMF includes data on D-Phenylalanine API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The D-Phenylalanine API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of D-Phenylalanine API suppliers with USDMF on PharmaCompass.
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