01 1Alkermes Plc
02 1SIGMA TAU
01 1DL-THERO-3,4-DIHYDROXYPHENYLSERINE
02 1ELN-CT-105G
01 1Ireland
02 1U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22903
Submission : 2009-06-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3848
Submission : 1980-06-18
Status : Inactive
Type : II
A Dl-Threo-3,4-Dihydroxyphenylserine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dl-Threo-3,4-Dihydroxyphenylserine, including repackagers and relabelers. The FDA regulates Dl-Threo-3,4-Dihydroxyphenylserine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dl-Threo-3,4-Dihydroxyphenylserine 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 Dl-Threo-3,4-Dihydroxyphenylserine supplier is an individual or a company that provides Dl-Threo-3,4-Dihydroxyphenylserine active pharmaceutical ingredient (API) or Dl-Threo-3,4-Dihydroxyphenylserine finished formulations upon request. The Dl-Threo-3,4-Dihydroxyphenylserine suppliers may include Dl-Threo-3,4-Dihydroxyphenylserine API manufacturers, exporters, distributors and traders.
click here to find a list of Dl-Threo-3,4-Dihydroxyphenylserine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dl-Threo-3,4-Dihydroxyphenylserine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dl-Threo-3,4-Dihydroxyphenylserine active pharmaceutical ingredient (API) in detail. Different forms of Dl-Threo-3,4-Dihydroxyphenylserine DMFs exist exist since differing nations have different regulations, such as Dl-Threo-3,4-Dihydroxyphenylserine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dl-Threo-3,4-Dihydroxyphenylserine DMF submitted to regulatory agencies in the US is known as a USDMF. Dl-Threo-3,4-Dihydroxyphenylserine USDMF includes data on Dl-Threo-3,4-Dihydroxyphenylserine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dl-Threo-3,4-Dihydroxyphenylserine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dl-Threo-3,4-Dihydroxyphenylserine suppliers with USDMF on PharmaCompass.
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