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 Urian manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urian, including repackagers and relabelers. The FDA regulates Urian manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urian 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 Urian manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Urian supplier is an individual or a company that provides Urian active pharmaceutical ingredient (API) or Urian finished formulations upon request. The Urian suppliers may include Urian API manufacturers, exporters, distributors and traders.
click here to find a list of Urian suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Urian DMF (Drug Master File) is a document detailing the whole manufacturing process of Urian active pharmaceutical ingredient (API) in detail. Different forms of Urian DMFs exist exist since differing nations have different regulations, such as Urian USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Urian DMF submitted to regulatory agencies in the US is known as a USDMF. Urian USDMF includes data on Urian's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Urian USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Urian suppliers with USDMF on PharmaCompass.
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