Regulatory History – Montreal

Regulatory History – Montreal2018-07-11T21:40:57+00:00

Montreal Facility

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.

Recent Inspections

  • September 2017, FDA General GMP, Compliant
  • December 2016, Health Canada Narcotics License Inspection, Compliant
  • November 2015, FDA Pre-Approval (Tablet), Compliant
  • September 2015, Health Canada General GMP, Controlled Drug (Schedule G), OTC, API Importation, Category IV Monograph, Narcotic and Prescription (Schedule F), Compliant