Certification
Health Canada Approved CDMOs
Compare CDMOs with Health Canada GMP approval for Canadian market access. Filter by product type, manufacturing capabilities, and facility location.
3 companies listed
About Health Canada GMP Compliance
Health Canada's Health Products and Food Branch Inspectorate conducts GMP inspections of pharmaceutical manufacturing facilities. Compliance is required for marketing drugs in Canada. Health Canada is a PIC/S member, meaning its GMP standards are harmonized with international requirements. Health Canada participates in the FDA-EMA-Health Canada Mutual Recognition Agreement, allowing reliance on partner agencies' inspection findings.
Canada's pharmaceutical market is the 10th largest globally, with strong demand for innovative drugs and biosimilars. CDMOs with Health Canada approval can serve this market directly. The SR&ED (Scientific Research and Experimental Development) tax credit program provides financial incentives for pharmaceutical R&D and manufacturing investment in Canada.
Companies (3)
UPM Pharmaceuticals
United States
UPM Pharmaceuticals is a U.S.-based CDMO specializing in late-stage commercial manufacturing of semi-solid and oral solid dose products. Operating from a 475,000 sq ft cGMP FDA-registered facility in Bristol, Tennessee, UPM is a family-owned company with 30+ years of experience. They handle DEA-controlled substances and provide services from technology transfer and scale-up through commercial manufacturing. Capabilities include formulation development, analytical development, coated tablet manufacturing, pharmaceutical serialization, aggregation, and full packaging and warehousing.
Small Molecule Drug ProductOral Solid DoseFormulation Development
F
Ferndale Labs CDMO
United States
With more than 30 years of CDMO experience, Ferndale Labs CDMO supports pharmaceutical and healthcare companies developing and manufacturing liquid and semi-solid drug products. Our FDA-registered facility specializes in semi-solid and liquid formulations, including creams, gels, lotions, ointments, suspensions and solutions for Rx, OTC, and medical device applications. Built on agility, flexibility, and versatility, Ferndale helps partners advance programs from development through clinical supply and commercial manufacturing.
Frequently Asked Questions
How does Health Canada GMP compare to FDA GMP?+
Health Canada GMP requirements are closely aligned with FDA and PIC/S standards. The MRA between Health Canada and the FDA/EMA means inspection findings are often shared, reducing the need for duplicate inspections. Key differences are minor: Health Canada has specific requirements for establishment licensing, Drug Identification Numbers (DINs), and bilingual labeling (English/French).
What are the benefits of manufacturing in Canada?+
Benefits include: Health Canada/FDA/EMA regulatory alignment (MRA), SR&ED tax credits for pharmaceutical R&D, competitive manufacturing costs versus the US, highly educated workforce, proximity to the US market, and a stable regulatory environment. Several global CDMOs have established Canadian operations to leverage these advantages.
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