Contract Manufacturing

Manufacturing in Huayi

Huayi Pharmaceutical manufactures solid dosage forms including tablets in various forms (film-coated, sugar-coated, enteric-coated, effervescent, soluble, chewable, buccal) and capsules filled with powders or pellets. New facilities for oral liquids and high potency products have been invested and are ready in 2020. Over 50 products are commercially manufactured for several European countries including some products developed from scratch by our R&D team.

We have successfully implemented serialisation and tamper-evident closures on our packing lines.

Quality management

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.

Production

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.

GMP Development

Our formulation development area can accommodate product trials at small scale with a complete set of modern production equipment. We can then manufacture pilot batches, clinical trial batches or process validation batches for you with batch sizes as low as 10,000 tablets and up to 100,000 or more in our certified GMP Development Workshop and commercial batches in the main workshop up to 4,000,000 tablets. This ensures a seamless connection between R&D and commercial production.

Clinical GMP Supply Capacity

Blending:

5 – 80kg

Wet granulation:

5 – 15kg

Fluid bed granulation:

6 – 15kg

Fluid bed drying drying:

6 – 15kg

Compression:

20,000 – 42,000 tablets/hr

Coating:

2 – 5kg

Commercial Manufacture Capacity

Blending:

40 – 2,000kg

Wet granulation:

40 – 200kg

Fluid bed drying:

30 – 200kg

Compression:

40,000 – 350,000 tablets/hr

Coating:

40 – 350kg

Encapsulation:

85,000 capsules/hr

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.

Research & Development

Quality management

Contract manufacturing

Integrated services

Partner with us

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.

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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.

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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.

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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.

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