Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1Ajinomoto OmniChem N.V.
03 1Bayer AG
04 1Showa Denko
01 15-HYDROXY-L-TRYPTOPHAN
02 3L-5-HYDROXYTRYPTOPHAN
01 1Belgium
02 1France
03 1Germany
04 1Japan
01 4Inactive
01 4Blank
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5056
Submission : 1983-09-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5078
Submission : 1983-09-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4849
Submission : 1983-03-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7545
Submission : 1988-06-21
Status : Inactive
Type : II
13
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A L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9), including repackagers and relabelers. The FDA regulates L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) 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 L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) supplier is an individual or a company that provides L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) active pharmaceutical ingredient (API) or L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) finished formulations upon request. The L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) suppliers may include L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) API manufacturers, exporters, distributors and traders.
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A L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) DMF (Drug Master File) is a document detailing the whole manufacturing process of L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) active pharmaceutical ingredient (API) in detail. Different forms of L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) DMFs exist exist since differing nations have different regulations, such as L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) DMF submitted to regulatory agencies in the US is known as a USDMF. L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) USDMF includes data on L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-5-HYDROXYTRYPTOPHAN (SEE ALSO 5-HYDROXYTRIPTOPHAN 56-69-9) USDMF is kept confidential to protect the manufacturer’s intellectual property.
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