Aesica Pharmaceuticals - Custom Synthesis, API and Finished Dosage Form Supplies

Aesica is an innovative and service driven supplier of APIs, formulated products and custom synthesis solutions with extensive experience in the pharmaceutical industry. Our products and services are distributed to the world’s major pharmaceutical markets including Europe, North America and Japan.

Aesica offers both primary and secondary contract manufacturing services and has the facilities and expertise to develop products from the early-phase clinical stage right through to commercial supply.

Aesica provides a tailored service incorporating integrated project management and working in partnerships on all projects, from individual development and scale-up to large-scale commercial manufacturing and technical transfers.

Aesica offers world-class development and manufacturing facilities:

• Fully equipped process development labs
• cGMP scale-up facilities
• Pilot plant for early phase process development
• 7 cGMP computer-controlled multi-product plants for commercial scale API manufacturing
• Formulation manufacturing facilities
• Packaging services
• A full range of facilities for the manufacture and formulation of chemical synthetic, potent compounds and anaesthetics

Custom synthesis - tailored chemistry, tailored service

Aesica offers custom synthesis solutions designed to give our customers unparalleled responsiveness and flexibility combined with complete assurance on quality and delivery. We provide a tailored service incorporating integrated project management and working in partnership on projects from the early phase clinical development right through to commercial supply.

Our comprehensive services include:

• Process development
• Analytical development
• cGMP manufacturing
• Scale-up
• Full regulatory support

Clinical supplies

We produce a broad range of chemical synthetic compounds including potent chemicals in quantities for use in Phase I to III clinical trials.

Flexible API development

API development services at Aesica are founded upon the expertise of our highly qualified team of chemists and purpose-built facilities to deliver all our customers’ process development and scale-up requirements.

World-class development facilities:

• Fully equipped process development labs
• cGMP scale-up facilities (20L)
• Potent development lab
• Pilot plant for early phase process development

Industry leading analytical facilities and regulatory support

Aesica provides a full analytical service. We offer method development and validation in compliance with ICH to support all your IND / CMC requirements. Our experienced regulatory team have submitted DMFs to all significant regulatory authorities around the world.

• Full compliance with ICH
• All equipment qualified and certified
• All reference materials supplied with CoA
• In-house stability sample storage

Commercial API manufacturing

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.

Finished dosage forms

Aesica offers the manufacture of formulated products. We have an extensive range of process technologies for manufacturing and packaging of pharmaceutical products.

Our formulation capabilities include:

• Solid dosage forms
• Liquid dosage forms
• Anaesthetics
• Potent drugs
• Analytical support

Aesica provides packaging in bottles, blister packs and sachets. We currently export to 80 different countries and have a highly flexible approach to customer requirements.

Exceptional quality

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

cGMP manufacturing and MHRA audits:

All 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 amongst 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.

Aesica – your partner of choice

Aesica strives to provide the best service in the industry and over the years we’ve proved ourselves to be the partner of choice to several of the top-ten global pharmaceutical companies, emerging life science companies and leading generic manufacturers. We strive to innovate in our technologies and in our commercial relationships, finding new ways of working together with our customers to achieve outstanding results.