Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Dr. Reddy's Laboratories
03 1Medichem S.A
04 1Neuland Laboratories
05 1Cipla
06 1GLAND PHARMA LIMITED
07 1MSN Laboratories
08 1Quimica Sintetica
09 1Solara Active Pharma Sciences
10 1YUNG ZIP CHEMICAL INDUSTRIAL
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-27
Pay. Date : 2024-01-22
DMF Number : 34751
Submission : 2020-06-16
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-01
Pay. Date : 2020-09-21
DMF Number : 34449
Submission : 2019-12-31
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-04
Pay. Date : 2020-10-15
DMF Number : 35211
Submission : 2020-10-26
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-16
Pay. Date : 2020-10-23
DMF Number : 35204
Submission : 2020-09-29
Status :
Type : II
A Edaravone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edaravone, including repackagers and relabelers. The FDA regulates Edaravone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edaravone 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 Edaravone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Edaravone supplier is an individual or a company that provides Edaravone active pharmaceutical ingredient (API) or Edaravone finished formulations upon request. The Edaravone suppliers may include Edaravone API manufacturers, exporters, distributors and traders.
click here to find a list of Edaravone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Edaravone DMF (Drug Master File) is a document detailing the whole manufacturing process of Edaravone active pharmaceutical ingredient (API) in detail. Different forms of Edaravone DMFs exist exist since differing nations have different regulations, such as Edaravone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Edaravone DMF submitted to regulatory agencies in the US is known as a USDMF. Edaravone USDMF includes data on Edaravone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Edaravone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Edaravone suppliers with USDMF on PharmaCompass.
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