The Pioneer in China! Yeedozencom Contributes to the Success of the Cetirizine Hydrochloride Tablets of Xinhua Pharmaceutical in the Quality and Efficacy Consistency Evaluation for Generic Drugs
On Aug. 16, the National Medical Products Administration issued Xinhua Pharmaceutical (Gaomi) Co., Ltd., a wholly-owned subsidiary of Xinhua Pharmaceutical with the Approval Letter of Supplementary Application (Approval No.: 2019B03488) for the Cetirizine Hydrochloride Tablets (Trade Name: Minda; Specification: 10mg), which has passed the quality and efficacy consistency evaluation for generic drugs. As the partner of Xinhua Pharmaceutical, Yeedozencom has contributed to the success of such product in the consistency evaluation by overall conducting the organization, implementation and quality assurance of the clinical studies on such product.
Xinhua Pharmaceutical (Gaomi) Co., Ltd. is the first in China who has such product passed the consistency evaluation and such product is the first OTC product in China which has passed the consistency evaluation, constituting another achievement of Xinhua Pharmaceutical after May 14 on which date the Glimepiride Tablets of Xinhua Pharmaceutical passed the quality and efficacy consistency evaluation for generic drugs!
The Cetirizine Hydrochloride Tablets are the safe, long-acting, highly selective and non-sedating histamine H1 receptor antagonist mainly indicated for seasonal rhinitis, perennial allergic rhinitis, allergic conjunctivitis as well as pruritus and urticarial caused by allergies. The global sales of the Cetirizine Hydrochloride Preparations were about USD 884,000,000 in 2018, including approximately CNY 124,000,000 from the domestic hospitals There are 27 listed pharmaceutical enterprises manufacturing the products of 10mg in China. This second generation of H1 receptor antagonist has been a clinically popular anti-allergic drug leading the domestic market of China. The Cetirizine Hydrochloride Tablets (10mg) are the star product manufactured by Xinhua Pharmaceutical (Gaomi) with the great market potential, which, on Jun. 22, 1999, were certified as the new drug and approved for manufacturing.
The Cetirizine Hydrochloride Tablets are the safe, long-acting, highly selective and non-sedating histamine H1 receptor antagonist mainly indicated for seasonal rhinitis, perennial allergic rhinitis, allergic conjunctivitis as well as pruritus and urticarial caused by allergies. The global sales of the Cetirizine Hydrochloride Preparations were about USD 884,000,000 in 2018, including approximately CNY 124,000,000 from the domestic hospitals There are 27 listed pharmaceutical enterprises manufacturing the products of 10mg in China. This second generation of H1 receptor antagonist has been a clinically popular anti-allergic drug leading the domestic market of China. The Cetirizine Hydrochloride Tablets (10mg) are the star product manufactured by Xinhua Pharmaceutical (Gaomi) with the great market potential, which, on Jun. 22, 1999, were certified as the new drug and approved for manufacturing.
About Xinhua Pharmaceutical
Xinhua Pharmaceutical has its inheritable, open, innovative and compatible corporate culture integrated with the law of value to improve the cultural strength, soft power and competitiveness, with the collective intelligence of all company staffs concentrated and the fine traditions and styles along with the entrepreneurship development stuck to. It is making every effort to build itself into the influential supplier of pharmaceutical preparations and the most competitive global manufacturing base of drug substances in China. The impressive performance achievements one after another have witnessed its milestone progresses.
About Yeedozencom
Yeedozencom is a professional and market-oriented service provider engaged in the full life-cycle management of drug research and development. Based on the rational cognition and deep expertise on the target products, Yeedozencom devotes itself to proposing the distinctive, proper and thoughtful solutions with warm concerns by experiencing and observing the challenges with Chinese characteristics in the full life cycle (e.g. R&D, manufacture, circulation and use) from the clients’ point of view. After years of accumulation, Yeedozencom has established and optimized the integrated service platform in support of the project operation management, clinical studies, registration services, biospecimen analysis, data management and statistics, aiming to minimize the time costs for pharmaceutical R&D, provide the value-added technical services and early launch the products to the market.
