Zhejiang Tianyu Pharmaceutical Co. Limited on Health Canada Inspection List
The FDA has scolded Zhejiang Tianyu Pharmaceutical in the wake of an inspection at the company’s plant in the Chinese province of Zhejiang between Feb. 28 and March 4, 2022. In FDA’s warning letter, dated Aug. 17, the regulator laid out a laundry list of complaints tied to lapses in Tianyu’s active pharmaceutical ingredient (API) production, which the company failed to amply address in its response to an earlier Form 483.
Zhejiang Tianyu Pharmaceutical Co., Ltd. Receives FDA Warning Letter
Two separate drug manufacturers have been cited by US regulators over several infractions including quality, cleaning and other issues.
The European Medicines Agency (EMA) issued a statement of noncompliance to a Zhejiang Huahai valsartan manufacturing site in China while the US Food and Drug Administration (FDA) placed it on import alert Friday in their ongoing investigations into probable human carcinogens.
EMA review of impurities in sartan medicines
China-based Zhejiang Tianyu Pharmaceuticals is no longer authorized to manufacture active substance for valsartan in the EU, the European Medicines Agency (EMA) said Monday.
The company Zhejiang Tianyu is no longer authorised to manufacture the valsartan active substance for EU medicines following the suspension of its CEP – a certificate verifying that the quality of its valsartan meets European requirements.
Additional recall of batches from a second Chinese Valsartan manufacturer in Germany – no products in Switzerland affected to date
EMA reviewing valsartan produced by another company Zhejiang Tianyu