Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
01 1Curia
02 1Celanese
03 1F.I.S. Fabbrica Italiana Sintetici
04 1Ipca Laboratories
05 1Kalintis Healthcare
06 1Mangalam Drugs & Organics Ltd
07 1Olon S.p.A
08 1Plantex Ltd.
09 1SALSBURY CHEMICALS INC
10 1Sms Lifesciences
11 1Solmag
12 1Sri Krishna Pharmaceuticals
13 1Trifarma
14 6Blank
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-23
Pay. Date : 2016-02-23
DMF Number : 30288
Submission : 2016-02-29
Status :
Type : II
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A Benzoic acid, 5-(aminosulfonyl)-4-chloro-2-((2-furanylmethyl)amino)- manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzoic acid, 5-(aminosulfonyl)-4-chloro-2-((2-furanylmethyl)amino)-, including repackagers and relabelers. The FDA regulates Benzoic acid, 5-(aminosulfonyl)-4-chloro-2-((2-furanylmethyl)amino)- manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzoic acid, 5-(aminosulfonyl)-4-chloro-2-((2-furanylmethyl)amino)- 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 Benzoic acid, 5-(aminosulfonyl)-4-chloro-2-((2-furanylmethyl)amino)- DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzoic acid, 5-(aminosulfonyl)-4-chloro-2-((2-furanylmethyl)amino)- active pharmaceutical ingredient (API) in detail. Different forms of Benzoic acid, 5-(aminosulfonyl)-4-chloro-2-((2-furanylmethyl)amino)- DMFs exist exist since differing nations have different regulations, such as Benzoic acid, 5-(aminosulfonyl)-4-chloro-2-((2-furanylmethyl)amino)- USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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