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

Aesica has the facilities and expertise to take products from the preclinical stage right through to the market place. We provide fully comprehensive services including process development, analytical development, cGMP manufacturing, scale-up and full regulatory support.

Our custom synthesis solutions are cost effective, incorporate the highest quality and regulatory standards and show our commitment to integrated project management. Our services are designed to meet all our customers' R&D and commercial supply needs and are tailored to their specific requirements.

• Fully equipped process development labs
• cGMP scale-up facilities
• Two pilot plants for early phase process development
• Seven 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, highly-potent compounds and anaesthetics

API DEVELOPMENT

Our highly qualified team of development chemists can carry out all your process development and scale-up requirements in our purpose-built development facilities.

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

• Process development lab and 20l scale-up facility
• High-potency process development lab and 10l scale-up facility
• Pilot plant
• High-potency pilot plant

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 with extensive chemical processing capabilities, including a high-potency facility. 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.

QUALITY CUSTOM SYNTHESIS, API AND FINISHED DOSAGE FORM SUPPLIES

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

cGMP manufacturing: all Aesica's manufacturing facilities are fully compliant with cGMP standards and requirements. FDA audits: during each FDA audit we have demonstrated that our standards are amongst the highest in the world.

MHRA audits: Aesica has been involved in the voluntary inspection programme since 2000.

ISO 9000-2000: Aesica is also in compliance with the international standard that promotes the use of a process approach to meet and exceed customer requirements.

WHY AESICA?

Our customers include top ten pharmaceutical companies, leading generics manufacturers and emerging companies across the major pharmaceutical markets.

• Over 25 years' experience in the industry
• Ability to take products from the preclinical stage right through to the market place
• Primary and secondary manufacturing capabilities
• Custom synthesis solutions with full analytical and
• Regulatory support
• Quick and efficient technical transfers
• Personalised service tailored to your specific requirements
• Commitment to provide the best service in the industry
• Proven excellence in quality
• Competitive in the global market