FDA, EMA approve Bayer’s sterile fill facility

BERKELEY, Calif. The Food and Drug Administration and the European Medicines Agency have given license approval to Bayer HealthCare for a new sterile filling facility on its Berkeley, Calif., campus, the company said Monday.

Bayer said the licenses from the FDA and EMEA will allow it to support the supply of its Kogenate line of products in the United States and European Union.

“These regulatory approvals for the Berkeley SFF represent a significant milestone for us and come at an opportune time given the continued expansion of the Kogenate product line in existing and new markets around the world,” Bayer HealthCare senior vice president and global head of product supply biotech Joerg Heidrich said. “We we look toward the future and the promise of true therapeutic advancements reflective of our strong product pipeline, it is crucial that our biotech facilities, infrastructure and processes are in line with the bold vision we have as an organization for developing therapeutic solutions for disease areas where there are still high unmet medical needs.”