CR Double-Crane subsidiary clears key drug manufacturing inspection for diabetes tablet

Double-Crane Tian'an Pharmaceutical (Guizhou) Co., Ltd., a controlled subsidiary of CR Double-Crane Pharmaceutical, recently received a "Drug GMP Compliance Inspection Notification Letter" from the Guizhou Provincial Drug Administration. The inspection, conducted from October 15 to October 17, 2025, confirmed compliance for the comprehensive workshop (four) tablet production line, which manufactures Metformin Empagliflozin Tablets (I). This approval marks the first GMP compliance inspection for this product prior to its market launch and was achieved without new capital investment, utilizing existing facilities and equipment. The production line has a design capacity of 500 million tablets per year.

The Metformin Empagliflozin Tablets (I) are used for blood glucose control in adults with type 2 diabetes already on empagliflozin and metformin. Developed by Boehringer Ingelheim International GmbH, the drug (marketed as "SYNJARDY" internationally and "Oushuangjing" in China) saw global sales of $103 million in 2024, with SYNJARDY accounting for $4,330.99 million. In the domestic market, as of 2024, the product's total sales (terminal price) reached 341 million yuan.

This successful GMP inspection ensures the company's continued stable product quality and production capacity, meeting market demand for related drugs. The company acknowledges that the listing and sales of pharmaceutical products are subject to national policies and market environmental changes, introducing some uncertainty.