Kamada announces U.S. FDA approval of application to manufacture CYTOGAM

Kamada announced that the U.S. Food and Drug Administration, FDA, has approved its application to manufacture CYTOGAM at the Company’s facility in Beit Kama, Israel. The FDA approval represents the successful conclusion of the technology transfer process for CYTOGAM from the previous manufacturer, CSL Behring. "The U.S. FDA approval of this application to manufacture CYTOGAM, which was granted within our expected timeline, following a successful on-site inspection by the FDA, represents a significant accomplishment for Kamada. This is the third product, in addition to GLASSIA(R) and KEDRAB(R), to be approved by the FDA for manufacturing at our Israeli site," said Amir London, Kamada’s Chief Executive Officer. "Our business continues to leverage the substantial benefits of the acquired portfolio of four FDA-approved IgGs, and we expect additional growth from these important products in 2023 and beyond. We intend to initiate commercial manufacturing of CYTOGAM at our Israeli facility shortly, which will positively impact the facility’s utilization and efficiency. Kamada’s continued investment in the manufacturing and distribution of CYTOGAM is representative of the Company’s commitment to ensuring the ongoing supply and availability of this important medicine to healthcare providers and solid organ transplant patients."