Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Alembic Pharmaceuticals Limited
03 1Apicore LLC
04 1Apotex Pharmachem
05 1HONOUR LAB LTD
06 1MSN Laboratories
07 3Maithri Drugs
08 1Zhejiang Huayi Pharmaceutical Co., Ltd.
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 : 33947
Submission : 2019-06-18
Status :
Type : II
A Selexipag manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Selexipag, including repackagers and relabelers. The FDA regulates Selexipag manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Selexipag 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 Selexipag manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Selexipag supplier is an individual or a company that provides Selexipag active pharmaceutical ingredient (API) or Selexipag finished formulations upon request. The Selexipag suppliers may include Selexipag API manufacturers, exporters, distributors and traders.
click here to find a list of Selexipag suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Selexipag DMF (Drug Master File) is a document detailing the whole manufacturing process of Selexipag active pharmaceutical ingredient (API) in detail. Different forms of Selexipag DMFs exist exist since differing nations have different regulations, such as Selexipag USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Selexipag DMF submitted to regulatory agencies in the US is known as a USDMF. Selexipag USDMF includes data on Selexipag's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Selexipag USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Selexipag suppliers with USDMF on PharmaCompass.
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