Kolb in Hedingen has been authorised by SwissMedic to manufacture and distribute active pharmaceutical ingredients and is subject to regular GMP inspections. Swissmedic is the Swiss Agency for the licensing and monitoring of therapeutic products.
Polysorbate-80 is produced according to GMP and will be offered to customers under the name of Hedisan-80. Further products, produced according to GMP, are available upon customer request.
For Kolb this is an important step-up in serving pharmaceutical customers. These customers typically use the polysorbate as excipient, however the certificate of GMP compliance by Swissmedic allows also the use in “API-like” applications. Because Swissmedic will audit Kolb yearly, customers can reduce their frequency of auditing Kolb. This is of course another huge advantage for Kolb’s customers.