Tiantan Biological subsidiary gets GMP compliance for recombinant FVIIa

Beijing Tiantan Biological Products Corp announced that its subsidiary, Chengdu Rongsheng Pharmaceutical, received a "Drug GMP Compliance Inspection Notification Letter" from the Sichuan Provincial Drug Administration. The letter confirms that Chengdu Rongsheng's recombinant product production workshop for "recombinant human coagulation factor VIIa for injection" complies with "Drug Production Quality Management Practices (revised 2010)" and relevant appendices. The inspection occurred from June 16 to June 19, 2025.

The inspection covered the production workshop, cell expansion and culture areas, purification areas, and packaging areas for the recombinant human coagulation factor VIIa for injection. Chengdu Rongsheng's "recombinant human coagulation factor VIIa for injection" has completed Phase III clinical trials and submitted an application for marketing authorization, which is currently under drug review.

The company stated that obtaining the GMP compliance notification is a crucial step. Full production of the drug can commence once the marketing authorization certificate and final production license are secured. However, future production and market conditions for this product may be influenced by national policies and market dynamics, indicating potential uncertainties.