Apotex Pharmachem Inc (API), Brantford, ON, Canada

Apotex Pharmachem Inc. (‘Pharmachem’) is a state-of-the-art, world class facility, serving as the centre of excellence for API R&D with cGMP API manufacturing capabilities for the Apotex group of companies

Situated on ~19 acres and located in Brantford, Ontario - 100 kms west of the Apotex Inc. main campus – making Pharmachem key strategic component to Apotex’s supply chain

Infrastructure capabilities and expertise include:

• Quality Assurance and Quality Control
• Manufacturing and technology operations
• Engineering, maintenance, supply chain, warehousing
• Fully compliant Kilo-Lab, pilot and commercial plants
• Capabilities to handle toxicity level 4 and controlled substances
• R&D Infrastructure for Process Development and Continuous Improvement

Employs new technologies to improve identification of novel forms and processes that generate a competitive advantage in the marketplace.

Patent portfolio numbers > 150, DMF’s > 400 in 40 different countries covering > 60 products

Aggressive master plan to assimilate new R&D (eg.. HTS, Rapid Analytical Chemistry Screening) and manufacturing techniques (Continuous flow and crystallization technology) to remain on forefront of technology.

• High pressure/high vacuum operating ranges
• Low and high temperature capabilities from: -80 °C to 150 °C
• Class III/IV production handling capabilities
• 64 KL total reactor volume
• 4 Commercial Plants/6 Work centers – 19,669 sq ft, 6900 sq ft. Cl 100K CR Finishing Areas

• Highly capable team for the end to end development of safe, novel and robust commercial manufacturing processes for production of Active Pharmaceutical Ingredients in forms that provide an intellectual property advantage for early market entry.
• Innovative API Synthetic Route Design
• Control Strategy development
• Impurity identification and synthesis
• Proficient Q_bD Process Development, Optimization
• Technology Transfer for scale-up and commercialization
• Process and Material Hazard Analysis
• Development, validation and transfer of Analytical Methodology for complete quality characterization of reference standards, API’s and associated raw materials and intermediates
• Regulatory support (initial filing, deficiency response and compendial compliance)
• Novel API Solid Form development with Intellectual Property / Patent Strategy
• 153 Unique Patent Inventions in US, CA + ROW (Process and Form) supporting the GAPI group
• DMF’s >400 in 40 countries covering >60 products