Heptakis-2,6-dimethyl-beta-cyclodextrin

Sugammadex is one of the greatest successes in the history of cyclodextrins. There is an increasing interest for this product and for the development of Sugammadex since the approval by the FDA resulted in a 3-4-fold increase in the global sales of the product. SGM is used in anesthesia as an injectable an...

Dexolve is the first generic USP and EP-conform Betadex Sulfobutyl Ether Sodium for:• solubility enhancement (10 to 100,000 fold) • Improvement of chemical stability • Increased bioavailability, facilitated delivery • Reduced aggregation • Moderate irritationor reduced side-effects • Maximiz...

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...