The Mississauga site in Ontario, Canada is spread across 183,000 Sq. The world-class facility is approved by the USFDA, Health Canada, EMA and PMDA. The site has expertise in manufacturing Tablets, Capsules, Semi-Solids and Liquids and is equipped with analytical services and a Microbiology lab. The site has packaging lines for Tablets, Liquids, Intranasal liquids, sachets, high speed tube filling and serialization capability for bottles and tubes. The site exports to many countries in North America,
South America, Asia, Russia, Middle East, Europe and AfricaThe Mississauga Site manufactures and packs a wide range of semi-finished and finished prescription and over the counter healthcare products in a range of dosage forms. There is capability to manufacture a wide range of complex products for commercial and clinical scale supply, including expertise in handling high potency API’s and tech transfer. The site is also equipped with eighteen commercial manufacturing modules (including three in the pilot plant) across a variety of manufacturing scales.
Flexible state of the art manufacturing and packaging
The site is equipped with an Automated Storage and Retrieval System (ASRS) to facilitate a highly flexible, multi scale facility. The ASRS allows palletised product to be moved between almost any manufacturing or packaging areas with minimal human intervention. As such, the production spaces and building configuration are highly flexible.
Semi-Solid and Liquid Manufacturing
There are three manufacturing suites capable of semi-solid manufacturing of creams, gels and ointments, with a variety of jacketed vessels from 500L Moltomat to 3800L Lee Vessel, all equipped with counter rotating agitators and homogenization.For liquids, the site has three manufacturing suites ranging from 600L to 3000L agitated vessels.
Laboratory infrastructure to support quality control, analytical development, process development, scale-up and physical characterisation activities, including a microbiology laboratory.The laboratories have undergone a significant investment in 2015 and support routine release, method development and technology transfer activities. The lab is equipped with seven walk-in stability chambers over a range of ICH conditions and is capable of freeze-thaw cycling.
Pilot Plant Capability
- R&D pilot plant includes three modules for clinical scale development
- Each module consists of 3-4 sub-rooms with a dedicated airlock and automated storage retrieval system access in each module, with one module containing an isolator to allow high potency API handling.
- The plant also includes a module with single pass of fresh air, allowing them to be used to manufacture products with solvents
- Semi- solid and liquid manufacturing is available from 2L scale to 125L scale in this area.
Eight packaging lines for a variety of dose forms for solid dose, semi-solids, sachets and liquids, including intra-nasal sprays. Serialization capability available across dose forms.
Solid Dose Manufacturing and Packaging
A variety of granulators, tablet presses, coaters, encapsulators and packaging lines would allow a total capacity of 800 million bulk tablets, 180 million capsules and 14 million bottles on a 24/5 shift pattern.
Excellent regulatory track record – five consecutive FDA audits over last eight years, with no observations on Form 483, typical or zero findings for other audits. Audits and approvals from many authorities including FDA, Health Canada, EMA, PMDA, ANVISA over the last five years