TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
01 1TAPI Technology & API Services
02 1Alembic Pharmaceuticals Limited
03 1Apotex Pharmachem
04 1Aurobindo Pharma Limited
05 1Cipla
06 1Emcure Pharmaceuticals
07 1Glenmark Life Sciences
08 1Jubilant Generics
09 1MSN Laboratories
10 1Macleods Pharmaceuticals Limited
11 1Megafine Pharma (P) Limited
12 1Par Pharmaceutical
13 1Torrent Pharmaceuticals Limited
14 1Unimark Remedies Limited
15 1Viatris
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-08-14
DMF Number : 22206
Submission : 2008-11-21
Status :
Type : II
A Darifenacin Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Darifenacin Hydrobromide, including repackagers and relabelers. The FDA regulates Darifenacin Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Darifenacin Hydrobromide 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 Darifenacin Hydrobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Darifenacin Hydrobromide supplier is an individual or a company that provides Darifenacin Hydrobromide active pharmaceutical ingredient (API) or Darifenacin Hydrobromide finished formulations upon request. The Darifenacin Hydrobromide suppliers may include Darifenacin Hydrobromide API manufacturers, exporters, distributors and traders.
click here to find a list of Darifenacin Hydrobromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Darifenacin Hydrobromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Darifenacin Hydrobromide active pharmaceutical ingredient (API) in detail. Different forms of Darifenacin Hydrobromide DMFs exist exist since differing nations have different regulations, such as Darifenacin Hydrobromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Darifenacin Hydrobromide DMF submitted to regulatory agencies in the US is known as a USDMF. Darifenacin Hydrobromide USDMF includes data on Darifenacin Hydrobromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Darifenacin Hydrobromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Darifenacin Hydrobromide suppliers with USDMF on PharmaCompass.
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