In addition to DSM, Relypsa also has an agreement with Lanxess Corp. for the supply of API. Both companies manufactured and supplied API for the clinical development program. Relypsa expects Lanxess to be the initial sole manufacturer named in its NDA but plans to submit a NDA supplement seeking approval for DSM as an additional manufacturer upon U.S. approval.
"We are very pleased to add DSM Fine Chemicals, a well-established contract manufacturer with significant experience in efficiently manufacturing polymers for therapeutic use, as a supplier of API for patiromer," said Wilhelm Stahl, Ph.D., senior vice president pharmaceutical operations at Relypsa. "Engaging another supplier is an important milestone towards preparing to cover our projected commercial demand and improving our security of supplies."