Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1ALP Pharm
03 1Jiangsu Sinopep Allsino Biopharmaceutical
04 1Natco Pharma
05 1Teva Pharmaceutical Industries
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2024-05-07
Pay. Date : 2024-04-25
DMF Number : 39602
Submission : 2024-03-08
Status :
Type : II
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PharmaCompass offers a list of Risdiplam API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Risdiplam manufacturer or Risdiplam supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Risdiplam manufacturer or Risdiplam supplier.
PharmaCompass also assists you with knowing the Risdiplam API Price utilized in the formulation of products. Risdiplam API Price is not always fixed or binding as the Risdiplam Price is obtained through a variety of data sources. The Risdiplam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Risdiplam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Risdiplam, including repackagers and relabelers. The FDA regulates Risdiplam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Risdiplam 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 Risdiplam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Risdiplam supplier is an individual or a company that provides Risdiplam active pharmaceutical ingredient (API) or Risdiplam finished formulations upon request. The Risdiplam suppliers may include Risdiplam API manufacturers, exporters, distributors and traders.
click here to find a list of Risdiplam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Risdiplam DMF (Drug Master File) is a document detailing the whole manufacturing process of Risdiplam active pharmaceutical ingredient (API) in detail. Different forms of Risdiplam DMFs exist exist since differing nations have different regulations, such as Risdiplam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Risdiplam DMF submitted to regulatory agencies in the US is known as a USDMF. Risdiplam USDMF includes data on Risdiplam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Risdiplam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Risdiplam suppliers with USDMF on PharmaCompass.
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