01 1Mitsui & Co
02 1Shasun Chemicals and Drugs Ltd
01 1MS-275 (N-(2-AMINOPHENYL)-4-[N-(PYRIDIN-3-YL-METHOXYCARBONYL)AMINOMETHYL]BENZAMIDO)
02 1SULPHONAMIDO ANILINE GR 40917A
01 1India
02 1U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14853
Submission : 2000-04-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8631
Submission : 1990-06-27
Status : Inactive
Type : II
A Aniline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aniline, including repackagers and relabelers. The FDA regulates Aniline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aniline 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 Aniline supplier is an individual or a company that provides Aniline active pharmaceutical ingredient (API) or Aniline finished formulations upon request. The Aniline suppliers may include Aniline API manufacturers, exporters, distributors and traders.
click here to find a list of Aniline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aniline DMF (Drug Master File) is a document detailing the whole manufacturing process of Aniline active pharmaceutical ingredient (API) in detail. Different forms of Aniline DMFs exist exist since differing nations have different regulations, such as Aniline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aniline DMF submitted to regulatory agencies in the US is known as a USDMF. Aniline USDMF includes data on Aniline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aniline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aniline suppliers with USDMF on PharmaCompass.
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