Tiantan Biological subsidiary achieves GMP compliance, expands production

Chengdu Rong Sheng Pharmaceutical Co., Ltd., a subsidiary of Beijing Tiantan Biological Products Co., Ltd., has received a "Notification of Pharmaceutical GMP Compliance Inspection" and an amended "Drug Manufacturing License" from the Sichuan Provincial Medical Products Administration. This approval confirms Chengdu Rong Sheng has successfully completed the production site change for its "Recombinant Human Coagulation Factor VII for Injection" product, paving the way for expanded production.

The inspection, conducted from August 18 to August 21, 2025, concluded that the facility complies with the "Good Manufacturing Practice for Pharmaceutical Products (2010 Revision)" and related annexes. The updated license specifically changes the production scope for "Recombinant Human Coagulation Factor VII for Injection" to allow for broader manufacturing.

This development follows the product's market approval in September 2023 and a supplemental application approval in July 2025 for the site change. While enabling increased production, the company cautions that future manufacturing volumes could be influenced by national policies and market conditions, advising investors of potential uncertainties.