Beijing Huasu Salt Hydrochloride Naltrexone Tablets, a subsidiary of CENTEK, passed the consistency evaluation
Beijing Huasu Pharmaceutical Co., Ltd., a subsidiary of CENTEK, recently received approval from the National Medical Products Administration for the hydrochloride naltrexone tablets (50mg) to pass the consistency evaluation of generic drug quality and efficacy. This medication is used for detoxification and relapse prevention in opioid-dependent individuals. The hydrochloride naltrexone tablets are the first variety in China to pass the consistency evaluation, with a cumulative research and development cost of 11.7389 million yuan
According to the Zhitong Finance APP, CENTEK (000931.SZ) announced that its subsidiary Beijing Huasu Pharmaceutical Co., Ltd. (hereinafter referred to as: Beijing Huasu) has received the "Drug Supplement Application Approval Notice" (Notice No.: 2025B04969) approved and issued by the National Medical Products Administration. It has been confirmed that the "Naltrexone Hydrochloride Tablets" (Specification: 50mg) produced by Beijing Huasu has passed the consistency evaluation of quality and efficacy for generic drugs.
Naltrexone hydrochloride can block the pharmacological effects of exogenous opioids and serves as an auxiliary drug for preventing relapse after detoxification in opioid-dependent individuals.
The original research enterprise for Naltrexone hydrochloride tablets is TEVA WOMENS in the United States, which was approved for marketing in the U.S. in 1984 under the brand name REVIA, in tablet form, with a specification of 50mg. There are also six generic drugs listed in the U.S. Currently, there are no original research or imported generic drugs of this variety available in the domestic market, with only Beijing Huasu having listed this product, available in specifications of 5mg and 50mg, and the registered trademark is Noxinsan®. Beijing Huasu's Naltrexone hydrochloride tablets (Specification 50mg) are the first products that have passed the consistency evaluation.
As of the date of this announcement, a total of 11.7389 million yuan has been invested in the research and development of the quality and efficacy consistency evaluation project for Naltrexone hydrochloride tablets
