4 Oct 2023

Cyclolab Dexolve Presentation

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After a precise development work CycloLab established and validated the production of pharma grade Betadex Sulfobutyl Ether Sodium formulation excipient (SBECD, DexolveTM) in 2008. This cyclodextrin is the main component of several commercial formulations worldwide acting as a solubility and stability enhancer.
DMF documentations were filed to the FDA (DMF No. 21922)in 2008, to Health Canada (DMF No. 2009-080) in 2009 and to China CDE in 2019 (No.F20190000489), all maintained ever since. In addition, CycloLab is a registered manufacturer of the Betadex Sulfobutyl Ether Sodium in the EudraGMDP database.

The facility is dedicated to the production of SBECD with multiple tons annual capacity (over 350 kg/batch). Our proprietary technology is extremely robust, no OOS results have been obtained after 150 manufactured batches. The production is carried out according to cGMP (OGYÉI-57792-7/2018) and ISO 9001 and the produ...

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  • HU
  • 2019
    On CPHI since
  • 4
  • 50 - 99
Company types
Drug delivery device Supplier/Manufacturer
Primary activities
Contract Research Organisation
Excipients Manufacturer

Other Content from CYCLOLAB Ltd. (2)

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    CycloLab Cyclodextrin Research and Development Ltd. is a private SME with the focus on cyclodextrin research and development for over 30 years. We are working in the fields of pharmaceutical, cosmetic and food industry, agrochemical, environmental and analytical applications of cyclodextrins.
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    CycloLab, being involved in the fight, manufactures the critical excipient: sulfobutyl-ether-BCD (SBECD, Dexolve™) that enables Remdesivir to work. The unexpected and sudden outbreak along with the quick spread of the coronavirus-disease and rapid increase of the cases draw a sudden need for Dexolve.