Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 2Biophore India Pharmaceuticals Pvt Ltd
02 1Ahk Tech
03 1Axitec
04 2Cilag AG
05 1Guangzhou Henovcom Biosciences
06 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
07 2MSN Laboratories
08 1Reliable Biopharmaceutical Corporation
09 1ScinoPharm Taiwan, Ltd
10 1Zhejiang Hisun Pharmaceutical
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-09
Pay. Date : 2021-09-28
DMF Number : 36221
Submission : 2021-08-30
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36222
Submission : 2021-08-31
Status :
Type : II
A Cladribine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cladribine, including repackagers and relabelers. The FDA regulates Cladribine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cladribine 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 Cladribine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cladribine supplier is an individual or a company that provides Cladribine active pharmaceutical ingredient (API) or Cladribine finished formulations upon request. The Cladribine suppliers may include Cladribine API manufacturers, exporters, distributors and traders.
click here to find a list of Cladribine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cladribine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cladribine active pharmaceutical ingredient (API) in detail. Different forms of Cladribine DMFs exist exist since differing nations have different regulations, such as Cladribine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cladribine DMF submitted to regulatory agencies in the US is known as a USDMF. Cladribine USDMF includes data on Cladribine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cladribine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cladribine suppliers with USDMF on PharmaCompass.
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