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