Huayi Pharmaceuticals (Anhui) Co., Ltd. is the first company passing European certification in Anhui. As a contract development and manufacturing organization (CDMO) dedicated to providing various dosage forms for Chinese and European markets, the company has been granted with EU GMP certificate in August 2010 after passing the GMP inspection by Medicines and Healthcare Products Regulatory Agency (MHRA). The certificate has been updated three times after re-inspections by MHRA. The company also has passed the quality inspections by more than 200 companies at home and abroad including Teva, KrKa and Novartis etc. and has passed several GMP compliance inspections by Chinese authorities (NMPA).
Since its establishment, the company has been providing joint venture cooperation, multiple dosage forms pharmaceutical development, commercial production on a contract basis, chemical synthesis research, and drug clinical testing services for research institutions and pharmaceutical sales enterprises etc. at home and abroad and has gradually built an open CDMO platform for international markets, which is dedicated in R&D of multiple dosage forms and focused on manufacturing of oral preparations, providing chemical synthesis as supplementary service.
Adhering to the corporate value of “create value and benefit for the world” and corporate spirit of “keep pragmatic and innovative all the time”, Huayi is fully engaged in providing customers with pharmaceutical development and production services of high efficiency, high quality and controllable cost and making high quality drugs at affordable cost. Huayi sincerely looks forward to cooperating with partners from all over the world on the pharmaceutical development, contract manufacture, MA application in both China and Europe and joint venture cooperation and developing both the international and domestic markets.
tablets/capsules manufactured per year on a contract basis
products successfully developed and commercialized
quality audits from well-known pharmaceutical companies at home and abroad
? Passed the fifth EU inspection in November 2024
? Synthesis laboratory constructed
? High potent solid preparation workshop under construction
? The Fourth Council Member Unit of the All-China Federation of Industry and Commerce Association of Pharmaceutical Commerce
? Top 20 Chinese Pharmaceutical CDMO Enterprises in 2023
? Main Structure Construction for Phase I Preparation Building in the New Site (Shenyang Road Site) completed
? Construction of synthesis laboratory started
? Construction of highly potent solid preparation workshop started
? Exports to EU reached 2.5 billion tablets
? First domestic product commercialized
? On September 13, 2022, the company was elected as the Chairman Unit of Anhui Preparation CDMO Industry Alliance
? Top 20 Chinese Pharmaceutical CDMO Enterprises in 2022
? 2022 (Industry) Leading Enterprise
? On October 8, 2021, Huayi’s Technical Center was established.
? In June 2021, the company passed the remote re-inspection by MHRA.
? On July 14th, 2020, the first bottle of liquid preparation was produced.
? In 2019, the company started the construction of oral liquid preparation and high potency workshop
? In 2018, the contract manufacture output reached 1.6 billion units
? In 2016, the company passed the on-site re-inspection by MHRA without any major deficiency
? The workshop extension has passed MHRA certification and the company's annual capacity was increased to 3 billion units
? In 2012, the company passed the on-site re-inspection by MHRA.
? In 2010, the company passed the on-site inspection by MHRA and started to perform the contract development, technical transfer and contract manufacture for EU market.
? In 2006, Huayi Pharmaceuticals (Anhui) Co., Ltd. was established and the workshop construction started.
