CPhI Online

EmpowerPharm certified to manufacture CBD products to prescription drug standards in Canadian first

8 Jun 2021

New $30 million manufacturing facility in Burlington, Ontario, will allow company to manage R&D in-house and scale production without reliance on third-party manufacturers

EmpowerPharm has become the first company to receive approval from the Canadian health authority to manufacture cannabidiol (CBD) products to prescription drug standards.

Having been granted a Drug Establishment Licence (DEL) by Health Canada for its new $30 million pharmaceutical manufacturing facility in Burlington, Ontario, EmpowerPharma is now certified as compliant with Good Manufacturing Practice (GMP) standards.

The facility allows EmpowerPharm to manage its R&D in-house and to scale its production without reliance on third-party manufacturers.

The company said it is now in a strong position to "disrupt" the pharmaceutical industry as it sets its sights on further R&D investments to provide scientific evidence physicians need to confidently prescribe new cannabis-based pharmaceutical products.

Currently, none of the cannabis products on the market used for anxiety have been approved by Health Canada due to a lack of supporting scientific evidence.

The company's Empower CBD is already in clinical trials as a medication indicated for anxiety.

EmpowerPharm will use synthetic CBD as its active pharmaceutical ingredient (API) to ensure their products do not contain THC (tetrahydrocannabinol) — the main psychoactive compound in cannabis — or any other unwanted cannabinoids that may be found in plant-based extracts.

The synthetic CBD will be GMP manufactured and tested, and will meet all regulatory requirements for API including product identity, potency and purity.

Four of the five Canadian-owned pharmaceutical manufacturers certified to manufacture oral dose prescription medicines were established more than 40 years ago. EmpowerPharma's new facility provides Canada with much-needed additional capacity in pharma R&D and manufacturing.

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