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 1Biocon
05 1Emcure Pharmaceuticals
06 1Glenmark Life Sciences
07 1HEC Pharm
08 1HONOUR LAB LTD
09 1Intas Pharmaceuticals
10 3MSN Laboratories
11 1Maprimed
12 1Novugen
13 1Shilpa Medicare
14 1Sun Pharmaceutical Industries Limited
15 1Tai Heng Industry Co., Ltd
16 1Viatris
17 1Zhejiang Huahai Pharmaceutical
18 1Zydus Lifesciences
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 : 2014-08-20
Pay. Date : 2014-04-25
DMF Number : 28148
Submission : 2014-04-27
Status :
Type : II
A gilenya manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of gilenya, including repackagers and relabelers. The FDA regulates gilenya manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. gilenya 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 gilenya manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A gilenya supplier is an individual or a company that provides gilenya active pharmaceutical ingredient (API) or gilenya finished formulations upon request. The gilenya suppliers may include gilenya API manufacturers, exporters, distributors and traders.
click here to find a list of gilenya suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A gilenya DMF (Drug Master File) is a document detailing the whole manufacturing process of gilenya active pharmaceutical ingredient (API) in detail. Different forms of gilenya DMFs exist exist since differing nations have different regulations, such as gilenya USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A gilenya DMF submitted to regulatory agencies in the US is known as a USDMF. gilenya USDMF includes data on gilenya's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The gilenya USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of gilenya suppliers with USDMF on PharmaCompass.
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