Healthy-volunteer data show sustained TL1A suppression and a profile supporting infrequent subcutaneous dosing. Caldera also licensed a second bispecific, targeting IL-17 and TL1A, from Qyuns Therapeutics.
|Articles|April 4, 2016
Roquette Receives EXCiPACT Certification
Author(s)BioPharm International Editors
The company announced that it received EXCiPACT certification in December 2015.
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Roquette, a French excipient manufacturer, announced on March 23, 2016 that it has received EXCiPACT certification.
SGS, one of the international auditors authorized to grant approval under this standard, audited and recommended that Roquette’s facility in Lestrem, France, receive EXCiPACT certification. The company received its certification in December 2015. Roquette received certification for the following excipients:
- Native starches (maize and wheat // B grade)
- Pregelatinised starches (product line Lycatab)
- Modified starches (product line Glycolys)
- Monohydrate and anhydrous glucoses
- Sorbitol powders (product line Neosorb P xx and Xtab xx)
- Sorbitol solutions (product line Neosorb 70/xx and Polysorb 85/70/00)
- Maltitol powders (product line SweetPearl)
- Maltitol solutions (Lycasin 80/55, Lycasin 75/75 and Polysorb 75/55)
- Mannitol powders (product line Pearlitol xx and Pearlitol Flash)
- Xylitol powders (product line Xylisorb)
“The EXCiPACT organization provides the suppliers’ customers (users) with high quality, reliable, and credible third-party certificates and audit reports,” said Paul Smaltz, head of Roquette’s pharma global business unit, in a statement. “This helps the suppliers’ customers to obtain the documentation required by their quality management systems, helping them meet their product regulatory requirements for excipients that have the same acceptance and value anywhere in the world.”
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