Tetra Bio-Pharma Granted Two OTC Drug Identification Numbers (DIN) by Health Canada

Published: January 20, 2020

Tetra Bio-Pharma Granted Two OTC Drug Identification Numbers (DIN) by Health Canada

Following its November 26th, 2019 Press Release, Tetra Bio Pharma Inc. announced that Health Canada has granted two Drug Identification Numbers (DIN) for the first over-the-counter (OTC) products to be marketed under its TERPACAN™ banner.

Tetra is in the process of finalizing supply, sales and distribution agreements with several companies, and anticipates launching TERPACAN™ products in Canadian pharmacy retail outlets by mid-2020. Additionally, Tetra will launch these products into the American and European markets in 2020, once it receives final marketing authorization in those countries. In preparation for a late 2020 launch in the United States, Tetra is in the process of finalizing a supply agreement with a contract manufacturer to establish manufacturing, and obtaining a National Drug Code (NDC) number for each drug, a requirement for all OTC drugs sold in the United States.

TERPACAN™ (hemorrhoids) is a topical formulation that will be used for the treatment of hemorrhoids, an itchy, painful and common condition affecting thousands of Canadians. TERPACAN™ (back & muscle pain) is indicated for the temporary relief of aches and pains of muscles and joints associated with backache, lumbago, strains, bruises, sprains, arthritic or rheumatic pain and pain of tendons and ligaments. In Canada the hemorrhoid treatment market has reached $22M, posting a steady 3% CAGR in 2019 while the highly competitive self-care pain treatment market has reached $432M, posting a 1% CAGR1.

“Tetra is focused on bringing well differentiated therapies to patients who are looking for new options to help relieve the pain and discomfort associated with activities of daily living,” said Dr. Guy Chamberland, Tetra Bio-Pharma’s CEO and Chief Regulatory Officer. “Terpacan for back and muscle pain, and Terpacan for hemorrhoids are products that align with our vision. The fact you’ll be able to find this brand at your corner drugstore means easy access for patients and caregivers.”

According to the Canadian Digestive Health Foundation nearly 20 million Canadians experience a digestive problem every year, and hemorrhoids are among the associated conditions creating an opportunity for awareness of self – help remedies. US numbers suggest that the problem affects nearly 4.5% of the US population. 2

Tetra Bio-Pharma is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.

Recent News

View All News Items

Latest Article

Legalization 2.0: IP and Regulatory Considerations for Edibles, Extracts and Topicals

Legalization 2.0: IP and Regulatory Considerations for Edibles, Extracts and Topicals

The legalization of cannabis edibles, extracts and topicals will expand the cannabis market and create new opportunities for producers, innovators and investors. According to a recent report from Deloitte, the Canadian market for these new cannabis products is expected to be worth $2.7 billion annually, with edibles accounting for more than half ($1.6 billion).

 

Read Article