Research & Development
Leave your generic drug development to our R&D team of experts in the Huayi China-Europe Pharmaceutical Research Institute, our R&D center. We will guide you in technology transfer from the lab to commercial production and product registration in our one-stop service.
Our team members have rich experience in the technology transfer process and project management, ensuring that your project will be carried out on time while adhering to the highest possible quality standard.
We have successfully transferred more than 50 products with nearly 100 strengths for customers and achieved commercial production.
GMP Development Workshop
The R&D department has an independent GMP Development Workshop with a complete suite of equipment with capacity from 5 kg to 80 kg where we can prepare pilot and scale-up batches. We can seamlessly integrate our production of small batches to full scale commercial production.
- Solubility/stability assessment
- Excipient screening
- API properties for processability
- Solid dose
- Tablets: sublingual, dispersible, effervescent, gastro-risistant, sugar and film-coated
- Capsules, hard gel: pellets, double-component, granules, powders, enteric-coated
- Oral liquids
- Modified release to match a specific dissolution profile
- Reverse formulation engineering
- Clinical trial supply manufacturing
- Clinical to commercial scale-up
- Process optimisation and validation
- Analytical method development
- Technology transfer
- Validation of methods for clinical and commercial applications
- Bespoke stability testing for accelerating product degradation and ICH stability testing for shelf life determination of finished drug products
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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