Moxifloxacin hydrochloride tablets of Haizheng Pharmaceutical Co., Ltd. passed who PQ certification

Zhejiang Haizheng Pharmaceutical Co., Ltd today announced that it has recently received the PQ (pre certification) confirmation letter (CPQ) issued by the World Health Organization (who) The following is the full text of the announcement: 1 Information of the certified product drug name: moxifloxacin hydrochloride tablet form: tablet specification: 400mg Application items: who preparation pre certification (PQ) Applicant: Zhejiang Haizheng Pharmaceutical Co., Ltd reply content: who according to the PQ application documents submitted by the company and on-site inspection and confirmation, the company's moxifloxacin hydrochloride tablets meet the standards recommended by who According to the confirmation letter, moxifloxacin hydrochloride tablets produced by the company have passed the PQ certification of who and have been listed in the list of who recommended procurement 2、 Moxifloxacin hydrochloride tablets are suitable for the treatment of upper and lower respiratory tract infections, and also belong to the second-line anti tuberculosis drugs The original research drug avelox was developed by Bayer company in Germany The company is the eighth enterprise approved by who to apply for PQ of moxifloxacin hydrochloride tablets in the world The main manufacturers of moxifloxacin hydrochloride tablets at home and abroad are Cipla Ltd, macleods pharmaceuticals Ltd, mylan Laboratories Ltd, Beijing Wansheng Pharmaceutical Co., Ltd., Guangdong dongyangguang Pharmaceutical Co., Ltd., etc According to statistics, the global sales volume of moxifloxacin hydrochloride tablets in 2017 is about US $23352600, of which the sales volume in the domestic market is about US $55313200; the global sales volume in January June 2018 is about US $125390000, of which the sales volume in the domestic market is about US $34613800 (data source IMS) Up to now, the company has invested about 7.2 million yuan in the drug R & D project In addition, according to the drug registration and acceptance database, up to now, there are 58 acceptance numbers reported for production, among which Jiangsu tiantianyi Pharmaceutical Co., Ltd., Guangdong dongyangguang Pharmaceutical Co., Ltd., Chongqing Huabang Pharmaceutical Co., Ltd and Beijing Wansheng Pharmaceutical Co., Ltd are the priority varieties for review and approval, among which Guangdong dongyangguang Pharmaceutical Co., Ltd and Beijing Wansheng Pharmaceutical Co., Ltd have been approved for production, and other two enterprises have also been approved for production The review and approval are in progress; although the drug is still in the production approval stage of Haizheng Pharmaceutical Co., Ltd., this time Haizheng Pharmaceutical Co., Ltd has passed the PQ certification of who and will have a positive impact on the company if it is listed in the WHO recommended procurement list.