Manufacturing facility expansion
Piramal Pharma Solutions is expanding its manufacturing facility in Aurora, Canada with a total investment of C$25m ($17.21m).
Announced in January 2020, the expansion will involve the addition of a wing for the manufacturing of active pharmaceutical ingredients (APIs).
Scheduled for completion by April 2021, the expansion will provide the company’s clients with access to new manufacturing space.
The manufacturing facility is at 110 Industrial Parkway North in Aurora, Ontario, situated 50km to the north of Toronto.
Piramal will add a manufacturing unit that will extend across an area of approximately 10,500ft².
The expansion will also involve the installation of two reactor suits along with a dedicated filter dryer room and a portable filter dryer.
Manufacturing wing will increase the capacity of the current facility and enable Piramal Pharma Solutions to meet the rising demand in the API domain.
It will also complement the capability of the existing plant to manufacture APIs and high potent APIs (HPAPIs) with occupational exposure limit (OEL) of less than 1mcg/m³.
The investment should also add filtration and drying capabilities to the service offerings at the facility, boosting the company’s footprint in Canada and cater to customer demand for integrated solutions.
The expanded facility is anticipated to comply with global regulatory standards. The company is looking to hire scientific and technical staff due to the additional capacity.
Piramal Pharma’s Aurora site is involved in the development and good manufacturing practice (GMP) of pharmaceutical new chemical entities (NCEs).
The existing facility features production pilot plants and specialises in advanced lab services.
It manufactures niche APIs and is equipped with 12 stainless steel or glass-lined pilot-scale reactors with capacity ranging between 200l and 2,000l.
Aurora site also includes a stand-alone hydrogenation facility, kilo lab, a facility for drying, milling and packaging, a scale-up lab of 15l, 25l or 50l, and a small scale GMP laboratory.
Service offerings of the facility include process development for pre-clinical and clinical supplies, selection of process, process validation, stability studies, manufacturing support and third party sample analysis.
The facility also provides analytical development and validation, assessment of critical parameters, as well as defining specifications for raw materials, intermediates, and finished products. It also has regulatory affairs and quality assurance support capabilities.
UK Medicines and Healthcare Products Regulatory Agency (MHRA), the US Food and Drug Administration (FDA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) conducted inspections at the plant.
The existing Aurora facility focuses on maintaining high standards in the areas of health, safety and environmental performance.
Piramal Pharma Solutions (PPS) is an arm of Piramal Enterprises and operates as a contract development and manufacturing organisation (CDMO).
The company provides end-to-end integrated services throughout the entire life cycle of drug development.
It has API facilities in Europe, Asia and North America. Aside from API manufacturing, it offers HPAPIs, key starting materials (KSMs), as well as finished dosage manufacturing and late life cycle management.
PPS manufactures, supplies commercial formulations for oral solids including, modified release formulations, conventional tablets, press coated tablets, hard gelatin capsules, from its FDA and MHRA-approved locations in Pithampur, India and Morpeth, UK. It also owns a sterile injectables manufacturing facility in Lexington, Kentucky, US.
The firm has more than 700 scientists supporting its research and development (R&D) efforts. Its facilities received accreditations from regulatory organisations in the US, Japan and Europe.
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