About us ...

Captisol® is a patented cyclodextrin for use in drug development and formulation.

FDA-approved, Captisol-enabled® medications are marketed by partners including Amgen, Pfizer, Merck & Co., Melinta Therapeutics, Acrotech Biopharma L.L.C. and Baxter International. Ligand also has License and Supply Agreements (LSAs) in place with a number of other pharmaceutical companies worldwide with Captisol-enabled® product candidates. Routes of administration investigated include parenteral, oral, ophthalmic, nasal, topical, oral, and inhalation.

The regulatory acceptance of Captisol is supported by extensive safety studies demonstrating their excellent systemic safety profile. In 1999, a Type V Drug Master File (DMF) was filed with the FDA. This regulatory safety data package, which includes greater than 80 volumes, has been updated over time and now supports the use of Captisol cyclodextrins in parenteral formulations as well as support for other routes of delivery. In addition, there is a Type V US DMF for Chemistry, Manufacturing and Controls (CMC) and DMFs have also been established in China and Japan. Multiple FDA divisions and ex-US regulatory agencies have evaluated the data package and permitted the use of Captisol cyclodextrins in clinical trials.

Published in scientific articles and utilized in a number of ongoing clinical trials by leading pharmaceutical and biotech companies, Captisol is recognized as a valuable and vital delivery technology whose use could mean the success or failure of a development program.

 
 

Activities ...

  • Proprietary Research & Manufacture
 
 

Services and Products ...

  • Finished Dosage
  • Excipients
  • Cyclodextrins
 
  • Licensing
  • Drug Delivery Technology
  • Drug Process Development
 
 
 
 
 
 
 
 

About Us

SURIMS is the new name for Actex Pharma Services which was a consultancy established in 2003, supporting companies in the identification, qualification and management of quality vendors and suppliers in ingredients and formulations.

The Pharmaceutical Services Directory supports the identification and on-boarding of quality suppliers and also incorporates software features that manage relationships between suppliers and their customers. These include the building and deployment of questionnaires and assessments, electronic signatures and sign-offs and project management between vendor/partner and customer.

Access to the features and software is available on a 'pay as you go' basis, or a customised version can be licensed for your company for its own supplier on-boarding and supplier management activities. Further information on our software services please contact Tel: +353 87 294 0436 or email info@surims.com

 
 
 

Get in Touch

The Pharmaceutical Services Directory
info@surims.com

 
 
 

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