In 2006, Huayi Pharmaceutical (Anhui) Co., Ltd., a Sino-British joint venture, was established. Land was purchased and the factory designed.
In 2010, we passed the on-site inspection by MHRA and received EU GMP certification. We became the 12th solid dose pharmaceutical plant to pass EU GMP accreditation in China. We started manufacture for the EU market.
In 2012, the company passed re-inspection by MHRA.
In 2016, the company passed re-inspection by MHRA without any major deficiencies. The workshop extension passed MHRA certification and the company’s annual capacity was increased to 3 billion units.
In 2018, contract manufacturing output reached 1.6 billion units and we began construction of our oral liquid preparation workshop and high-potency workshop.
In 2019, we were named as one of the Top 50 Growing Enterprise of the Chinese Pharmaceutical Industry.
Why become our partner?
Since our establishment, we have completed site transfers of over 50 products and supply a billion doses a year to European customers. We have successfully developed dossiers for Europe resulting in granted marketing authorisations.
We have recently expanded our capability to develop products to Chinese standards also and can produce dossiers that meet both European and Chinese requirements. Together with our associated company Velocyte, we can also offer bio-equivalence studies in China to seamlessly complete the clinical part of the development.
Huayi is committed to upgrading and developing our services. We aim to increase our current manufacturing capacity from 3 billion units to 5 billion units to satisfy demand. We are building new facilities for high-potency and oral liquid manufacturing scheduled for production in 2020.
Analytical method development
Bio-equivalence studies in China through our partner company
Contract manufacturing and commercial supply
Full regulatory compliance (toxicological assessment, serialisation etc.)
Research & Development
We are experienced in technology transfers and scale-up process for commercial production. Having transferred over 50 products for our customers and registering almost 100 strengths to date, we are prepared to take on new challenges in pharmaceutical development with our experienced team from Huayi China-Europe Pharmaceutical Research Institute.Read More
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Huayi’s QA team is committed to ensuring your project adheres to EU cGMP standards at every step of production from development to commercial manufacture. We will work hard to ensure that your project will be completed on time to the highest quality and stay focused and communicative throughout the process.Read More
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In 2018, our contract manufacturing output reached 1.6 billion units. Huayi manufactures solid oral dosage forms including film-coated, sugar-coated, enteric-coated, effervescent, soluble, chewable and buccal tablets as well as capsules. Our high-potency and liquid preparation facilities will be ready in 2020.Read More
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We offer bioequivalence studies for your next project in China. Through our partners Weida Clinical Research and Velocyte Analytical Technology, we can conduct clinical trials, biological sample testing, dissolution profiling and stability studies. We can then scale-up from the test batch to commercial production.Read More
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