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 1Glenmark Life Sciences
06 1HEC Pharm
07 1Hetero Drugs
08 1Intas Pharmaceuticals
09 1Lupin Ltd
10 1MSN Laboratories
11 1Macleods Pharmaceuticals Limited
12 1Megafine Pharma (P) Limited
13 1Sun Pharmaceutical Industries Limited
14 1Unichem Laboratories 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 : 2013-07-30
Pay. Date : 2013-04-09
DMF Number : 27048
Submission : 2013-06-12
Status :
Type : II
A Prasugrel Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prasugrel Hydrochloride, including repackagers and relabelers. The FDA regulates Prasugrel Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prasugrel Hydrochloride 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 Prasugrel Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prasugrel Hydrochloride supplier is an individual or a company that provides Prasugrel Hydrochloride active pharmaceutical ingredient (API) or Prasugrel Hydrochloride finished formulations upon request. The Prasugrel Hydrochloride suppliers may include Prasugrel Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Prasugrel Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prasugrel Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Prasugrel Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Prasugrel Hydrochloride DMFs exist exist since differing nations have different regulations, such as Prasugrel Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prasugrel Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Prasugrel Hydrochloride USDMF includes data on Prasugrel Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prasugrel Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prasugrel Hydrochloride suppliers with USDMF on PharmaCompass.
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