Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
01 2Cohance Lifesciences
02 1TAPI Technology & API Services
03 1Apotex Pharmachem
04 1Dipharma
05 1Emnar Pharma
06 2Glenmark Life Sciences
07 1Hetero Drugs
08 1Juzen Chemical Corporation
09 1Maithri Drugs
10 1Perrigo API India Private Limited
11 1Procos
12 1Sumitomo Pharma
13 1Sun Pharmaceutical Industries Limited
14 1Viatris
15 1Wockhardt
16 1Zydus Lifesciences
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-12
Pay. Date : 2019-06-11
DMF Number : 31298
Submission : 2017-01-04
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18197
Submission : 2005-03-23
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-15
Pay. Date : 2018-11-26
DMF Number : 33256
Submission : 2018-10-09
Status :
Type : II
A Zonisamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zonisamide, including repackagers and relabelers. The FDA regulates Zonisamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zonisamide 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 Zonisamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zonisamide supplier is an individual or a company that provides Zonisamide active pharmaceutical ingredient (API) or Zonisamide finished formulations upon request. The Zonisamide suppliers may include Zonisamide API manufacturers, exporters, distributors and traders.
click here to find a list of Zonisamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zonisamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Zonisamide active pharmaceutical ingredient (API) in detail. Different forms of Zonisamide DMFs exist exist since differing nations have different regulations, such as Zonisamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zonisamide DMF submitted to regulatory agencies in the US is known as a USDMF. Zonisamide USDMF includes data on Zonisamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zonisamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zonisamide suppliers with USDMF on PharmaCompass.
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