Contract development and manufacturing organisation (CDMO) Bora, which specialises in modified release (MR) and solvent production, has reported a successful FDA general inspection for its facility in Zhunan, Taiwan.
The company recently hosted the site’s fifth successful inspection by the US regulatory body of its global supply facility located south-west of Taipei, with zero 483 observations.
Bobby Sheng, CEO at Bora Pharmaceuticals, said: “Since acquiring this facility in early 2018, we have built a phenomenal team that is dedicated to adhering to strict quality standards. In fact, over 25% of the site’s workforce is devoted to quality assurance and control, so this approval is testament to them and the rest of our team.
“This latest FDA inspection underlines our commitment to servicing the US market and supporting our own future growth strategy. Our customers consistently praise our quality standards and efficiency, often saying the facility is in the top five external manufacturing facilities they’ve ever visited in the world.
“We now intend to invest further into our US growth strategy to continue to be the most agile CDMO partner we can be.”
The company is Taiwan’s biggest CDMO, responsible for producing 52% of finished dosage form exports from Taiwan to the US and 11% from Taiwan to ROW. The Zhunan facility is also licensed by the MHRA, TFDA and is PIC/S certified.
Sheng added: “The advantages of modified release drugs are becoming increasingly recognised across the industry. 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."