The pharmaceutical industry in Canada is one of the largest and fastest-growing sectors, contributing significantly to the country’s economy. With a market valued at approximately $30 billion CAD, Canada ranks among the top 10 global pharmaceutical markets. The country’s strong healthcare infrastructure, robust regulatory framework, and attractive incentives make it an ideal location for launching a pharmaceutical business.
If you’re a foreign entrepreneur looking to open a pharmaceutical company in Canada, this guide will cover the process, documents needed and some of the best pharma companies in Canada for you.
Understanding the Pharmaceutical Market in Canada
Market Size and Growth Trends
- Canada’s pharmaceutical industry has been growing at an average rate of 4-5% yearly.
- The country has a universal healthcare system, ensuring high demand for pharmaceutical products.
- Over 50% of Canada’s pharmaceutical products are exported, making it a lucrative industry for global investors.
- Key hubs include Ontario, Quebec, and British Columbia, home to major pharmaceutical companies and biotech startups.
Regulatory Landscape
- Health Canada is the primary regulatory body overseeing pharmaceutical products.
- The Patented Medicine Prices Review Board (PMPRB) ensures fair drug pricing.
- Canada follows strict Good Manufacturing Practices (GMP) and drug safety regulations.
- The rising demand for healthcare has enormous growth potential for biotech and generic medications.
Process to Open a Pharmaceutical Company in Canada
The process to open a pharmaceutical company in Canada is explained below:
Step 1: Choose a Business Structure
Before starting your pharmaceutical business in Canada, you must select an appropriate legal structure:
- Sole Proprietorship – Simple and cost-effective, but the owner has unlimited liability.
- Partnership – Suitable for joint ventures, where partners share profits, responsibilities, and liabilities.
- Corporation – The most preferred option for pharmaceutical businesses due to tax benefits, limited liability, and the ability to raise capital.
Step 2: Select a Province for Incorporation
Canada allows incorporation at both the federal and provincial levels.
Some of the best provinces for pharmaceutical businesses include:
- Ontario – Home to a vast pharmaceutical network and innovation hubs.
- Quebec – Offers R&D incentives and has a strong biotech sector.
- British Columbia – Ideal for companies focusing on biopharmaceuticals.
- Alberta – A growing hub for pharmaceutical research and manufacturing.
Step 3: Register a Business Name
- The name of your firm has to be unique and not similar to existing businesses.
- Perform a name search through the NUANS (Newly Upgraded Automated Name Search) database.
- Register the approved name with Corporations Canada if incorporating federally or with the respective provincial authorities.
Step 4: Obtain a Business Number (BN)
- A Business Number (BN) is granted by the Canada Revenue Agency (CRA) and is required for taxation related purpose.
- The BN is used for corporate tax, payroll, and import/export transactions.
- Register for GST/HST
- Businesses with annual revenues exceeding $30,000 CAD has to register for the Goods and Services Tax (GST) or Harmonized Sales Tax (HST).
- Each province has a different tax rate, which can range from 5% to 15%.
Documents Needed to Open a Pharmaceutical Company in Canada
- Business registration certificate
- Drug Establishment License (DEL)
- Site License (for manufacturing)
- GMP compliance certification
- Import/Export License (if applicable)
- Intellectual property and patent documentation
- Health Canada approvals for pharmaceutical products
Best Pharmaceutical Companies in Canada
- Apotex Inc. – Canada’s largest generic drug manufacturer.
- Bausch Health – A leader in ophthalmology and dermatology drugs.
- Sanofi Canada – Specializing in vaccines and rare diseases.
- Teva Canada – A top player in the generic pharmaceutical market.
- Pfizer Canada – A major contributor to drug development and innovation.
Benefits of Starting a Pharmaceutical Company in Canada
- Access to a growing market with rising healthcare needs.
- Government incentives and R&D tax credits for pharmaceutical companies.
- Strong IP protection laws ensuring patent security.
- Well-established healthcare infrastructure supporting pharmaceutical innovation.
- Global export opportunities, with Canada being a major pharma exporter.
Conclusion
Starting a pharma company in Canada presents a wealth of opportunities for foreign entrepreneurs. With a strong regulatory framework, global market access, and government incentives, Canada is a prime destination for pharmaceutical businesses. If you’re ready to open a pharmaceutical company in Canada, taking the right steps—from business registration to regulatory compliance—will ensure long-term success.
Need help setting up your pharmaceutical business? Speak with our business professionals to help you with the operational, financial, and legal facets of starting a pharmaceutical business in Canada.
FAQ’s
This can easily be checked by seeing if the NIP or REGON are associated with the company in question. In the case of a sole proprietorship, they don’t own a KRS number so the NIP or REGON needs to be checked.
Share capital amount around PLN 50,000 is necessary to form a company, and it is also crucial to have NIP or REGON also including the register of VAT payment.
CEIDG is a business book of entries with info on self-employed entrepreneurs. Any sole trader must register in CEIDG.
