Manufacturing in Huayi
We have successfully implemented serialisation and tamper-evident closures on our packing lines.
Our production facilities and quality management system fully comply with Chinese as well as EU GMP and we are able to offer our services to companies that wish to enter the Chinese domestic market in addition to contract manufacture for the EU.
Our production capacity is around 3 billion units currently and we manufactured 1.5 billion tablets/capsules in 2021. We will expand our capacity in future to meet demand.
Clinical GMP Supply Capacity
5 – 80kg
5 – 15kg
Fluid bed granulation:
6 – 15kg
Fluid bed drying drying:
6 – 15kg
20,000 – 42,000 tablets/hr
2 – 5kg
Commercial Manufacture Capacity
40 – 2,000kg
40 – 200kg
Fluid bed drying:
30 – 200kg
40,000 – 350,000 tablets/hr
40 – 350kg
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 have built new facilities for high-potency and oral liquids manufacturing and put in to use in 2021.
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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