Aesica is an innovative and service driven supplier of APIs, formulated products and custom synthesis solutions with extensive experience in the pharmaceutical industry. Aesica has the facilities and expertise to develop products from the early-phase clinical stage right through to commercial supply.

We provide 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 develop- ment 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 facili- ties
• Packaging services
• In-house artwork generation and services
• A full range of facilities for the manufacture and formulation of potent compounds and anaesthe- tics
• All facilities are MHRA certified and all API facilities are FDA approved

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 develop- ment labs
• cGMP scale-up facilities (20L)

INDUSTRY LEADING ANALYTICAL
FACILITIES & 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 certi- fied
• 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.

Aesica Formulated 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.

Aesica Active Pharmaceutical Ingredients

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 – OUR API PRODUCTS

In addition to manufacturing products on behalf of our customers, Aesica is also a leading supplier for the following range of APIs:

• PAROXETINE HYDROCHLORIDE ANHYDROUS / HEMIHYDRATE
• FLURBIPROFEN
• SODIUM FLURBIPROFEN
• R(-) FLURBIPROFEN
• S(+) FLURBIPROFEN
• DOTHIEPIN HCI

For further information :
Aesica PDF Brochure
Active Pharmaceutical Ingredients (APIs)
Formulations
Custom synthesis
Contract manufacturing
Process development and scale-up

Aesica Pharmaceuticals Limited
Quorum 5
Balliol Business Park East
Benton Lane
Newcastle upon Tyne
NE12 8EZ
United Kingdom
T: +44 (0)191 218 1960
F: +44 (0)191 266 9447
info@aesica-pharma.com

Aesica, LLC
Park 80 West - Plaza Two
Suite 200
Saddle Brook, New Jersey 07663
USA
T: +1.201.291.2705
F: +1.201.960.1828
michael.staff@aesica-pharma.com

Aesica Custom Synthesis Solutions