Taiwanese CDMO Gains FDA Approval for Zhunan Facility

Contract development and manufacturing organization, Bora Pharmaceuticals, has announced it has achieved success in the latest FDA general inspection of its Zhunan facility with zero 483 observations.

“Since acquiring this facility in early 2018, we have built a phenomenal team that is dedicated to adhering to strict quality standards,” said Bobby Sheng, CEO at Bora Pharmaceuticals in a Sep. 10, 2019 press release. “This latest FDA inspection underlines our commitment to servicing the United States market and supporting our own future growth strategy. We now intend to invest further into our US growth strategy to continue to be the most agile CDMO partner we can be.”

In addition to its recent FDA approval, the facility in Zhunan is also licensed by the Medicines and Healthcare products Regulatory Agency in the United Kingdom. Furthermore, the site, which employs more than 300 people, is certified by the Taiwan FDA as well as the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

“The advantages of modified release drugs are becoming increasingly recognized across the industry,” Sheng added. “Our ability to meet that growing demand with large-scale solvent manufacturing and at the same time handle complex drug products such as fixed-dose combination products (FDC) at commercial scale has been a major advantage for us and a huge benefit to our customers.”

Source: Bora Pharmaceuticals