Relypsa, DSM Fine Chemicals Partner in API Manufacturing PactBy
The biopharmaceutical company Relypsa, Inc. has entered into a multi-year commercial manufacturing and supply agreement with DSM Fine Chemicals Austria NFG GMBH & Co. KG for the active pharmaceutical ingredient (API) for patiromer, the company’s polymer in development for the treatment of hyperkalemia. DSM Fine Chemicals is a business unit of the newly formed DPx Holding B.V., which also owns Patheon Pharma Services and Banner Life Sciences.
In addition to DSM Fine Chemicals, Relypsa also has an agreement with Lanxess Corporation for the supply of API. Both Lanxess and DSM Fine Chemicals have manufactured and supplied API that was used during the company’s clinical development program. Relypsa expects Lanxess will be the initial sole manufacturer named in its planned new drug application (NDA). The company plans to submit a NDA supplement seeking approval for DSM Fine Chemicals as an additional manufacturer upon potential US approval of patiromer.