Aesica - API and Formulated Product Contract Development and Manufacture

Aesica supplies active pharmaceutical ingredients and formulated products contract development and contract manufacturing services to many of the world's leading pharmaceutical companies and emerging biotechnology organisations.

Aesica's products and services are distributed to the world's major pharmaceutical markets. We offer comprehensive contract manufacturing services for primary and secondary pharmaceutical products, from early clinical phases through to market production.

API contract development and manufacture

Aesica offers API contract development services designed to give our customers unparalleled responsiveness and flexibility combined with complete assurance on quality and delivery. Aesica's API development services are founded upon the expertise of our highly qualified team of chemists and purpose-built facilities to deliver our customers processing needs. Our API contract development services include:

• Kilo lab
• Pilot plant
• Analytical development
• Potent development lab

Aesica has more than 25 years' experience in supplying bulk APIs to the global pharmaceutical industry. Aesica has seven computer-controlled multi-product plants all with extensive chemical processing capabilities, several of which include facilities for manufacturing potent compounds. We manufacture a broad range of APIs and are experienced in managing technical transfers quickly and efficiently.

Formulated products contract development and manufacture

Aesica provides contract development and manufacturing services for formulated products. Through R5 Pharmaceuticals, a subsidiary of Aesica, we provide early-stage formulation development and product manufacture. R5 is able to support most dosage forms, including sterile preparations, and assists preclinical and early-phase clinical biopharmaceuticals organisations.

With our full-service facilities and expertise, we offer a seamless transfer to full-scale manufacturing for formulated products.

Aesica offers an extensive range of process technologies for manufacturing and packaging of pharmaceutical products. Our contract manufacturing capabilities for formulated products include:

• Solid dosage forms
• Liquid dosage forms
• Anaesthetics
• Potent drugs
• Packaging
• Artwork services

FDA and ISO compliant contract development and manufacture

Our state-of-the-art quality control / testing facilities ensure that all our customers receive the highest quality products.

• cGMP manufacturing and MHRA audits: Aesica manufacturing facilities are fully compliant with cGMP standards and requirements
• FDA audits: all Aesica API facilities are FDA inspected. During each FDA audit we have demonstrated that our standards are among the highest in the world
• ISO 9001-2000: Aesica is also in compliance with the international standard that promotes the use of a process approach to meet and exceed customer requirements

Global API and formulated product contract manufacturer

As an established global contract manufacturer, Aesica works in partnership with our customers to understand their specific needs and provide a tailor-made and responsive approach.

We deliver a rapid, cost-effective and compliant solution in an ever-changing regulatory and economic environment, giving our customers assurity of supply with products that require complexity.

We utilise our expertise, capabilities and facilities to deliver an innovative, value-added solution, helping our customers to stay ahead of the competition.

About Aesica

Aesica is one of the UK's fastest growing companies and over the last five years has experienced an increase in turnover from £25m to approximately £100m. In addition to its headquarters in Newcastle upon Tyne, UK, Aesica has four development and manufacturing sites across the UK including Cramlington, Queenborough, Ponders End and the recently acquired R5 Pharmaceuticals in Nottingham. Furthermore Aesica has offices in New York, San Diego and Shanghai and employees 750 people.