With inspections and approvals for branded and generic products for the US, Canadian and European markets, our Montreal facility is a highly compliant full service cGMP pharmaceutical contract manufacturing and packaging facility. The facility has been manufacturing drug products for over 40 years and has an excellent compliance record.
Ideally suited for customers who wish to apply for not only US, but Canadian and EU approvals, the plant has been continually updated over the years with state of the art equipment including cutting-edge laboratory and manufacturing technologies.
The Montreal site is perfectly suited to handle both high-volume or small batch contract manufacturing, for a wide range of solid, liquid and non sterile semi-solid dosage forms. The facility includes laboratories for analytical method development, transfers, release and microbiology testing. A variety of packaging services are also available.
- FDA Inspections
- November 2014 – FDA General Inspection (solid, semi-solid and liquid)
- November 2015 – PAI (solid dosage form)
- Health Canada Inspections
- May 2013, Health Canada Controlled Substance (schedule G).
- February 2014, Health Canada Precursor Inspection.
- September 2015, General GMP Health Canada; Prescription (schedule F), controlled Drug (schedule G), OTC, Category IV/Monograph and API importation
- Mutual Recognition by EMEA (EU)