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...

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CYCLOLAB Ltd.

  • Country/Region:
    Hungary
  • On CPHI since:
    2019
  • Certificates:
    4
  • Employees:
    50 - 99
Company types
Drug delivery device Supplier/Manufacturer
Primary activities
Contract Research Organisation
Excipients Manufacturer
View company profile
Categories
more categories Show less

CYCLOLAB Ltd.

  • Country/Region:
    Hungary
  • On CPHI since:
    2019
  • Certificates:
    4
  • Employees:
    50 - 99
Company types
Drug delivery device Supplier/Manufacturer
Primary activities
Contract Research Organisation
Excipients Manufacturer
View company profile

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CYCLOLAB Ltd. resources (1)

  • Cyclolab Dexolve Presentation

    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...