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Solid Oral Dose Manufacturing
Solid Oral Dosage and NanoCrystal Colloidal Dispersion® (NCD) Manufacturing
EDT’s main production facilities are located in Athlone, Ireland and Gainesville Georgia.
EDT has manufactured finished solid oral pharmaceutical products for clients for well over 30 years.
Range of manufacturing services
In addition to formulation development, Elan Drug Technologies provides a range of manufacturing services to include analytical development, clinical trial manufacturing, scale-up, product registration support and supply chain management for client products.
As a preferred manufacturer, Elan Drug Technologies provides clients:
- experience, proven track record, infrastructure and capacity in solid oral dosage form manufacture
- capacity to manufacture up to 3 billion units annually of solid oral dosage product
- 250,000 sq ft of cGMP facilities between its sites in Ireland and U.S.
- excellent compliance record, FDA/EMEA/JMHLW GMP approved sites
- modern facilities dedicated supply chain support and launch management capabilities
- on site Regulatory Support
- mature infrastructure
- development & tech transfer capabilities
- well established workforce whose focus is on partnering with customers
- proprietary formulation technologies to improve product performance, where appropriate
Elan Drug Technologies' collaborative approach consistently provides clients with:
- high-quality product
- flexible, responsive service
- on-time delivery
- competitive pricing
- exceptional compliance track record
- efficient technical transfers
- modern facilities in Europe and U.S.
- FDA/EMEA-licensed sites
- regulatory support
- efficient inventory coverage
- experience with handling controlled substances (DEA approved)
With modern facilities in Europe and the United States, companies can select from a broad range of manufacturing options to fit their precise product requirements:
- encapsulation
- tabletting
- film coating
- wet granulation (high shear and fluid bed)
- wurster coating
- direct compression
- bead manufacture
- finished product packaging (bottle/blister/vial)
- blending
- release testing, including steriles
- controlled substance processing (through schedule II)
Development Services
Elan Drug Technologies has extensive knowledge in oral drug delivery technologies, which can allow for the development of patentable line extensions for your products.
Our range of development services include:
- formulation and product strategy development
- analytical method development, materials and product characterisation, pilot and commercial stability
- process development, scale-up and transfer to on-site commercial manufacture
- full project leadership and management
Athlone, Ireland Facility
Located on a 40 acre site, with over 200,000 sq ft of dedicated GMP grade facilities, Elan Drug Technologies has a proven manufacturing track-record with over 20 products optimised and manufactured for clients world-wide. The FDA/EMEA licensed facility has a nominal capacity of 2.5 billion unit doses per annum, depending on product configurations.
Gainesville, Georgia, U.S. Facility
Located on 148 acres of land, with a total area under roof of approximately 87,000 sq. ft. This Dedicated cGMP facility has the capacity to manufacture up to 500m solid dosage units a year. FDA and DEA registered it is licensed to manufacture schedule II drugs.
10 different products are manufactured and/or packaged at this site at present. As a global supplier of ethical pharmaceuticals, our facilities provide product to the U.S., many European territories and South East Asia.
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