Frontier Biotechnologies is proud to announce that its wholly-owned subsidiary, Sichuan Frontier Biopharmaceutical Co., Ltd., has successfully obtained clearance from the U.S. Food & Drug Administration (FDA) for its manufacturing site inspection. This significant achievement confirms Sichuan Frontier's adherence to Current Good Manufacturing Practice (CGMP) regulations and paves the way for the production and commercialization of FB4001 (Teriparatide Injection).

In August 2023, Frontier Biotechnologies and Sichuan Frontier underwent a rigorous "Prior Approval Inspection" (PAI) conducted by the US FDA. The on-site inspection thoroughly evaluated Sichuan Frontier's manufacturing processes and facilities to ensure compliance with the stringent manufacturing requirements for FB4001. The positive inspection report, known as the Establishment Inspection Report (EIR), was recently issued by the US FDA, with no adjustments required and a result of 0-483, indicating "No Action Indicated" (NAI).

This clearance from the US FDA is a testament to Frontier Biotechnologies' commitment to maintaining the highest standards of quality and compliance in its manufacturing operations. The company's manufacturing site has been certified to be fully compliant with CGMP regulations, ensuring the production of safe and effective pharmaceutical products.

Obtaining clearance from the US FDA for our manufacturing site inspection is a significant milestone for Frontier Biotechnologies. It is a testament to its unwavering commitment to quality and compliance. This clearance not only validates Frontier’s manufacturing capabilities but also reinforces its dedication to delivering safe and effective therapies to patients in need.

With this clearance, Frontier Biotechnologies is well-positioned to file an Abbreviated New Drug Application (ANDA) for FB4001, further advancing its mission to bring innovative and life-changing therapies to patients worldwide. The company's dedication to upholding high standards in product development and manufacturing ensures that FB4001 meets all regulatory requirements for commercial production and sales.