Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1ChemWerth Inc
03 1ALP Pharm
04 1Alembic Pharmaceuticals Limited
05 1MSN Laboratories
06 1ScinoPharm Taiwan, Ltd
07 1Synbias Pharma Limited Liability Company
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-23
Pay. Date : 2019-12-12
DMF Number : 35049
Submission : 2020-08-12
Status :
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-04
Pay. Date : 2024-10-25
DMF Number : 36081
Submission : 2021-07-22
Status :
Type : II
A Nelarabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nelarabine, including repackagers and relabelers. The FDA regulates Nelarabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nelarabine 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 Nelarabine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nelarabine supplier is an individual or a company that provides Nelarabine active pharmaceutical ingredient (API) or Nelarabine finished formulations upon request. The Nelarabine suppliers may include Nelarabine API manufacturers, exporters, distributors and traders.
click here to find a list of Nelarabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nelarabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Nelarabine active pharmaceutical ingredient (API) in detail. Different forms of Nelarabine DMFs exist exist since differing nations have different regulations, such as Nelarabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nelarabine DMF submitted to regulatory agencies in the US is known as a USDMF. Nelarabine USDMF includes data on Nelarabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nelarabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nelarabine suppliers with USDMF on PharmaCompass.
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