Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 2Biophore India Pharmaceuticals Pvt Ltd
02 1Dr. Reddy's Laboratories
03 1Apotex Pharmachem
04 1Cipla
05 2Maithri Drugs
06 1Raks Pharma
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-27
Pay. Date : 2018-03-27
DMF Number : 32572
Submission : 2018-03-20
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-01
Pay. Date : 2018-02-16
DMF Number : 31475
Submission : 2017-03-13
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-09
Pay. Date : 2018-05-30
DMF Number : 32860
Submission : 2018-05-30
Status :
Type : II
A Eliglustat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eliglustat, including repackagers and relabelers. The FDA regulates Eliglustat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eliglustat 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 Eliglustat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eliglustat supplier is an individual or a company that provides Eliglustat active pharmaceutical ingredient (API) or Eliglustat finished formulations upon request. The Eliglustat suppliers may include Eliglustat API manufacturers, exporters, distributors and traders.
click here to find a list of Eliglustat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eliglustat DMF (Drug Master File) is a document detailing the whole manufacturing process of Eliglustat active pharmaceutical ingredient (API) in detail. Different forms of Eliglustat DMFs exist exist since differing nations have different regulations, such as Eliglustat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eliglustat DMF submitted to regulatory agencies in the US is known as a USDMF. Eliglustat USDMF includes data on Eliglustat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eliglustat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eliglustat suppliers with USDMF on PharmaCompass.
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