US FDA issued import ban on Huahai Pharmaceutical raw materials and finished drugs

Medical Network September 29th, September 28th, the US Food and Drug Administration released a report on Huahai Pharmaceutical (600521, SH) on its official website about the recall of valsartan (an ARB antihypertensive drug). Import alarm.

"Daily Economic News" reporter noted that the FDA said that it stopped importing all active pharmaceutical ingredients (API, domestically known as APIs) produced by Huahai Pharmaceutical, and finished drugs based on these APIs.

The FDA said the above actions were taken after recent inspections of Huahai Pharmaceutical's facilities.

Huahai Pharmaceutical's previous announcement showed that on June 15th, during the process of optimizing the production process of valsartan bulk drug, the company discovered and verified one of the unknown impurities as nitrosodimethylamine (NDMA). It is a trace impurity produced by the current registration process in the normal production process of valsartan bulk drug. This impurity contains genotoxicity, but there is limited evidence of carcinogenicity to humans. From the perspective of risk prevention, the company decided to take the initiative to recall it at home and abroad. The valsartan bulk drug, together with the relevant domestic customers, decided to take the initiative to recall the domestically marketed valsartan preparation products produced by the company's valsartan bulk drug; on July 6, the company exported valsartan bulk drug The situation of detecting trace amounts of NDMA impurities was reported to the domestic drug regulatory authorities; on July 14, Huahai Pharmaceutical issued a notice to recall the company's valsartan preparations listed in the US.