HydRx Wellness Receives GMP Compliant Canadian Pharmaceutical Drug Establishment License

Media Release

Toronto, Ontario (September 16, 2024) HydRx Wellness is pleased to announce receipt of a Drug Establishment License (DEL) issued by Health Canada in accordance with the Food and Drugs Act and its Regulations. The DEL confirms that the Hydrx Wellness manufacturing facility is in compliance with Good Manufacturing Practices (GMP) standards.

The license can be used for the manufacturing of pharmaceutical drug products including pharmaceutical products containing cannabis. This includes drugs that have marketing authorizations as either novel or generic pharmaceutical drug products containing cannabis.

The DEL allows HydRx Wellness  to leverage the Mutual Recognition Agreements (MRA) established between Canada and other global regulatory authorities, including the European Economic Area, as well as the three countries of the European Free Trade Association, Australia, the UK and Switzerland.

In addition, as a member of the International Pharmaceutical Inspection Co-operation Scheme, the Health Canada DEL can be recognized in over 50 different countries including the U.S. and the majority of the EU.

“HydRx Wellness has achieved a significant milestone with the issuance of our Drug Establishment Licence. This new license adds to our Natural Health Product (NHP) manufacturing license and our Licensed Producer (LP) cannabis license to truly make us a full-service pharmaceutical manufacturing company that can support global customers for approved drugs, natural health products and medical cannabis products,” explained Trevor Folk, CEO, HydRx Wellness. “HydRx Wellness joins a small number of companies who can use cannabis plants and extracts to produce a pharmaceutical grade cannabis product fit for global distribution”.

About HydRx Wellness

 HydRx Wellness is a GMP Compliant full-service manufacturer of softgels, gummies, suppositories and liquids for Approved Drugs, Natural Health Products and Cannabis.

HydRx Wellness began as a vertically integrated Health Canada Licenced Producer of cannabis with a focus on developing and manufacturing cannabinoid derivative products for the medical and adult use markets. HydRx Wellness is permitted to sell cannabis-based products to medically authorized patients, provincially licensed bodies and export to approved foreign entities.

The following is a list of the various important milestones achieved by Hydrx Wellness:

• HydRx was first approved by Health Canada as a Controlled Drug Substances Licensed Dealer in October of 2016.

• HydRx Wellness subsequently received a Licensed Producer Cultivation License (LP) in September of 2017.

• HydRx Wellness holds a site license for the manufacture and distribution of Natural Health Products (NHP).

• HydRx Wellness holds a site Drug Establishment License (DEL) for the manufacture of approved drugs.

• The Hydrx Wellness manufacturing facility is now GMP Compliant and a leading exporter of cannabis bulk and finished goods.

Contact Us

For more information about HydRx Wellness, visit www.hydrx.ca

Manufacturing Facility & Head Office

1130 Champlain Court

Whitby, Ontario L1N 6K9

Research Center

911 Park Avenue, New York, NY 10075