Shandong Longzen Pharmaceutical Co., Ltd. has officially received the GMP Compliance Inspection Notice issued by the Shandong Provincial Drug Administration.
This clearance marks the official start of commercial production and market sales for our Teneligliptin Hydrobromide API, ushering our core business into a new era of rapid development.
Key Audit Highlights (June 24–26, 2026):
•Rigorous Inspection: A 3-day on-site audit and document review evaluated our quality management systems, staffing, equipment management, material & product control, production management, and QA/QC operations.
•Full GMP Compliance: The inspection team praised Longzen's robust, efficient quality system and strict site management, confirming full compliance with GMP standards.
•Major Success: Following our Gadobutrol API receiving its GMP compliance notice in July 2025, this milestone represents another major achievement in Longzen's growth.
Our Commitment:
Adhering to our quality policy—"Crafting Quality Medicines with Precision"—Longzen will continue to increase R&D investment, elevate product quality and production management, and supply high-quality APIs to support the healthy development of the pharmaceutical industry.
