SGM

SGM
Product Description

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 antidote for rocuronium and similar NM blocking agents. 

CycloLab has vast experience in the production of Per-6-halogen-gamma CD intermediates and has developed Sugammadex via various process routes and related compounds, supported by sensitive analytical tools to characterize the products.
We provide: high purity standards (intermediates, Sugammadex, key process impurities), formulation development, optimization of API production...

CYCLOLAB Ltd.

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

CYCLOLAB Ltd.

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

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CYCLOLAB Ltd. resources (3)

  • News Company introduction – Cyclolab Cyclodextrin Research and Development Ltd

    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.
  • Brochure Cyclolab Dexolve Presentation

    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...
  • News Remdesivir with Dexolve: fight against COVID-19

    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.