China-EU Partnership
Huayi Pharmaceuticals is a Sino-British joint venture CDMO offering contract development and pharmaceutical manufacturing services. We believe that manufacturing here at our site in Hefei, Eastern China offers several key advantages. Manufacturing in China allows significant cost-savings while maintaining production of high-quality medicines that adhere to GMP standards. Working with us also represents an opportunity to penetrate into the Chinese pharmaceutical market – we are able to produce dossiers which can be registered in both China and EU countries and offer other technical help through our integrated services.
Quality
Quality is at the heart of all we do. Our comprehensive quality management system ensures the timeliness and accuracy of all generated data. We are fully certified in China and Europe, allowing us to commercially manufacture finished dosage products for both EU and domestic Chinese customers.
Technical and Regulatory Expertise
We employ an experienced team in house and have access to specialist technical consultants in our innovative R&D department. Our staff have run development projects resulting in several MAs in the EU and have an exciting pipeline at various stages of development. Let us develop your next product!
Cost-effective Supply and Customer-focused Service
We believe that we can offer significant cost savings to your drug development and commercial supply. But that is not enough. Medicine supply chains are under strain everywhere; at Huayi we pride ourselves on delivering on time, in full. And should something happen such that we can’t meet that standard for any reason, our open communication and customer focus means we will tell you as soon as possible and work with you to find a solution so you don’t lose business and patients don’t go without their medicine.
Integrity
Maintaining integrity is important to us as one of our company’s core values. China’s rapidly improving regulatory oversight and our strict adherence to European GMP standards demonstrates our strong commitment to our customers’ manufacturing and quality standards.Infrastructure and Supply Chain
China’s heavy investment into the pharmaceutical industry means we have access to a wide range of API suppliers and we can work closely with them in their own language, speeding development projects and protecting supply. China’s infrastructure has equally benefitted from investment with strengthened transport and supply chains throughout the country, allowing for easy sourcing of high-quality materials.
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.
API characterisation
Analytical method development
Formulation development
Scale up
Validation
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 More01 / 04
Quality Management
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 More02 / 04
Contract Manufacturing
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 More03 / 04
Integrated Services
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 More04 / 04