Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Cipla
03 1Eli Lilly
04 1Intas Pharmaceuticals
05 1Luitpold Pharmaceuticals, Inc.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2025-04-09
Pay. Date : 2025-03-06
DMF Number : 35513
Submission : 2020-12-31
Status :
Type : II
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PharmaCompass offers a list of Sodium Thiosulfate 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 Sodium Thiosulfate manufacturer or Sodium Thiosulfate supplier for your needs.
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PharmaCompass also assists you with knowing the Sodium Thiosulfate API Price utilized in the formulation of products. Sodium Thiosulfate API Price is not always fixed or binding as the Sodium Thiosulfate Price is obtained through a variety of data sources. The Sodium Thiosulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A sodium thiosulfate pentahydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of sodium thiosulfate pentahydrate, including repackagers and relabelers. The FDA regulates sodium thiosulfate pentahydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. sodium thiosulfate pentahydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A sodium thiosulfate pentahydrate supplier is an individual or a company that provides sodium thiosulfate pentahydrate active pharmaceutical ingredient (API) or sodium thiosulfate pentahydrate finished formulations upon request. The sodium thiosulfate pentahydrate suppliers may include sodium thiosulfate pentahydrate API manufacturers, exporters, distributors and traders.
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A sodium thiosulfate pentahydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of sodium thiosulfate pentahydrate active pharmaceutical ingredient (API) in detail. Different forms of sodium thiosulfate pentahydrate DMFs exist exist since differing nations have different regulations, such as sodium thiosulfate pentahydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A sodium thiosulfate pentahydrate DMF submitted to regulatory agencies in the US is known as a USDMF. sodium thiosulfate pentahydrate USDMF includes data on sodium thiosulfate pentahydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The sodium thiosulfate pentahydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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