Maithri Drugs: Dedicated to your API needs.
01 1Maithri Drugs
02 1Jiangxi Synergy Pharmaceutical
03 1Otsuka Chemical Co Ltd
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43855
Submission : 2026-03-30
Status :
Type : II
17
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A (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid, including repackagers and relabelers. The FDA regulates (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic 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.
click here to find a list of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid supplier is an individual or a company that provides (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid active pharmaceutical ingredient (API) or (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid finished formulations upon request. The (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid suppliers may include (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid API manufacturers, exporters, distributors and traders.
click here to find a list of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid active pharmaceutical ingredient (API) in detail. Different forms of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid DMFs exist exist since differing nations have different regulations, such as (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid DMF submitted to regulatory agencies in the US is known as a USDMF. (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid USDMF includes data on (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 3 companies offering (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid
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