Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
01 1Aarti Pharmalabs
01 1TERT-BUTYL-[(3S)-3-AMINO-2-OXO-2,3,4,5-TETRAHYDRO-1H-1-BENZAZEPIN-1-YL] ACETATE (PR-415)
01 1India
01 1Active
01 1Blank
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36677
Submission : 2022-02-25
Status : Active
Type : II
A Benazepril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benazepril, including repackagers and relabelers. The FDA regulates Benazepril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benazepril 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 Benazepril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benazepril supplier is an individual or a company that provides Benazepril active pharmaceutical ingredient (API) or Benazepril finished formulations upon request. The Benazepril suppliers may include Benazepril API manufacturers, exporters, distributors and traders.
click here to find a list of Benazepril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benazepril DMF (Drug Master File) is a document detailing the whole manufacturing process of Benazepril active pharmaceutical ingredient (API) in detail. Different forms of Benazepril DMFs exist exist since differing nations have different regulations, such as Benazepril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benazepril DMF submitted to regulatory agencies in the US is known as a USDMF. Benazepril USDMF includes data on Benazepril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benazepril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benazepril suppliers with USDMF on PharmaCompass.
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