01 1SIGMA TAU
02 1Waterstone Pharmaceuticals Inc.
01 1L-Ala-pAF-OH HCl
02 1L-B-3,4-DIHYDROXYPHENYLALANINE (L-DOPA) AND METHYL ESTER HCL.
01 1China
02 1U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5778
Submission : 1985-03-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27558
Submission : 2013-08-25
Status : Inactive
Type : II
A Levodopa Methyl Ester manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levodopa Methyl Ester, including repackagers and relabelers. The FDA regulates Levodopa Methyl Ester manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levodopa Methyl Ester 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 Levodopa Methyl Ester manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levodopa Methyl Ester supplier is an individual or a company that provides Levodopa Methyl Ester active pharmaceutical ingredient (API) or Levodopa Methyl Ester finished formulations upon request. The Levodopa Methyl Ester suppliers may include Levodopa Methyl Ester API manufacturers, exporters, distributors and traders.
click here to find a list of Levodopa Methyl Ester suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levodopa Methyl Ester DMF (Drug Master File) is a document detailing the whole manufacturing process of Levodopa Methyl Ester active pharmaceutical ingredient (API) in detail. Different forms of Levodopa Methyl Ester DMFs exist exist since differing nations have different regulations, such as Levodopa Methyl Ester USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levodopa Methyl Ester DMF submitted to regulatory agencies in the US is known as a USDMF. Levodopa Methyl Ester USDMF includes data on Levodopa Methyl Ester's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levodopa Methyl Ester USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levodopa Methyl Ester suppliers with USDMF on PharmaCompass.
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