drugset / Press release

Voluntary Announcement - The Group's production workshop for cough suppressant product "Benzonatate Soft Capsule" passed onsite inspection by the U.S.FDA

2014-12-17 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗

— 1 — Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. CSPC PharmaCeutiCal GrouP limited ʮ ̡ (Incorporated in Hong Kong under the Companies Ordinance) (Stock code: 1093) VoluNtarY aNNouNCeme Nt the GrouP ’S ProduCtio N work ShoP for CouG h SuPP reSSaNt ProduCt “Be NzoNatate Soft CaPSule ” PaSSed o NSite iNSP eCtio N BY the u. S. fda The board of directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company ”, together with its subsidiaries (the “ Group”)) announces that the Group has received the report from the U.S. Food and Drug Administration (“ u.S. fda”) confirming that the Group’s production workshop for cough suppressant product “Benzonatate Soft Capsule” has passed the U.S. FDA onsite inspection. Benzonatate soft capsule is a non-narcotic cough suppressant used for relieving cough symptoms. Upon absorption by the body, benzonatate is distributed along the respiratory tract with significant suppressing effect on the pulmonary stretch sensors and sensory nerve endings. It is able to suppress the pulmonary vagal reflex and thereby block the input impulses of cough reflex, achieving cough suppressing effects without suppressing respiration. Clinically it is commonly used for irritable dry cough and intermittent cough caused by acute bronchitis, bronchial asthma, pneumonia and lung cancer. Benzonatate Soft Capsule is one of the Group’s products with Abbreviated New Drug Application submitted to U.S. FDA. The passing of the onsite inspection by the U.S. FDA signifies a breakthrough progress in expanding into the international market of the Group’s soft capsule products. This lays a solid foundation for opening up international markets such as the United States, Australia, New Zealand, South Africa, Turkey for this product category. By order of the Board CSPC Pharmaceutical Group limited Cai dongchen Chairman Hong Kong, 17 December 2014 — 2 — As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. FENG Zhenying, Mr. CHAK Kin Man, Mr. PAN Weidong, Mr. ZHAO John Huan, Mr. WANG Shunlong, Mr. WANG Huaiyu, Mr. LU Jianmin, Mr. WANG Zhenguo and Mr. WANG Jinxu as executive Directors; Mr. LEE Ka Sze, Carmelo as non-executive Director and Mr. CHAN Siu Keung, Leonard, Mr. WANG Bo, Mr. LO Yuk Lam, Mr. YU Jinming and Mr. CHEN Shilin as independent non-executive Directors.

The release as fetched from its publisher. irasia.com ↗