The French ingredients company Roquette has announced an investment to increase production of its polyol product Mannitol with a new capacity in its US facilities eyeing a growth in health food and pharmaceutical excipient markets.
The move is to add Mannitol production to its US manufacturing facility, which already engaged in producing Maltitol, Sorbitol, and other new products. The increasing demand for Mannitol as a suitable carrier excipient in various applications including pharmaceutical manufacturing is behind Roquette's decision to invest further in this product line, according to the company officials. The investment, according to this, is not only in terms of manufacturing capacity to ensure continuous supply and reliability, but also in terms of product development.
The company is keen in development of the product, as it has increased focus around innovation and development of products for the healthcare industry. According to M Edouard Roquette, Global Marketing Director for the Group, "It is clear that Mannitol is a sophisticated polyol with exceptional application potential for the pharma and health areas. This product line falls within Roquette's core development and know-how where the company has a wealth of experience. We will continue to play to this strength in developing Mannitol, making it one of the cornerstones of the excipient's industry."
A major GMP quality assurance programme has been carried out on the endotoxin controlled pyrogen -free Mannitol line, making this product the only Mannitol PF to be GMP certified according to the new ICH Q7A rules.
"This GMP upgrade has been a major investment for our QA group; this was started as a voluntary upgrade to satisfy our healthcare customers. It is satisfying to see that it is now becoming the industry's standard and it is gratifying to be able to guarantee full compliance to the new rules. The upgrade concerns formally the API Mannitol grade, but in terms of quality safety it also benefits the Mannitol grade excipients produced on the line," informed M Ph Olivier, Corporate QA Director.
The consistent and reliable availability of Mannitol has made it a particularly suitable excipient for the pharma and health industries. As an excipient, Mannitol has the qualities of low chemical reactivity, extraordinarily low level hygroscopicity for moisture sensitive formulation along with taste and mouth feel, sources said.