Zhejiang Tianyu Pharmaceutical (300702.SZ) passes on-site inspection by the US FDA.
28/02/2025
GMT Eight
Zhejiang Tianyu Pharmaceutical (300702.SZ) announced that the company underwent an on-site inspection by the US Food and Drug Administration (FDA) for cGMP (current Good Manufacturing Practice) from November 21 to November 29, 2024. Recently, the company received an Establishment Inspection Report (EIR) issued by the FDA, and the inspection result, classified as VAI (Voluntary Action Indicated), passed smoothly. The scope of the inspection was for the Losartan Potassium active pharmaceutical ingredient.
The successful FDA on-site inspection indicates that the company's drug production activities continue to meet the requirements of cGMP set by the US FDA, providing a solid guarantee for the company's ongoing expansion into the US market and positively impacting the expansion into globally regulated markets.