LSL PHARMA GROUP SUCCESSFULLY OBTAINED U.S. FDA CERTIFICATION FOR THE MANUFACTURING OF OPHTHALMIC OINTMENTS FOR COMMERCIALIZATION IN THE UNITED STATES

Executive Summary

• LSL Pharma Group Inc. obtained U.S. FDA certification for its ophthalmic ointment manufacturing site (Steri‑Med Pharma Inc.).
• The certification enables the company to manufacture and commercialize ophthalmic ointments, including Avaclyr®, in the United States and opens pathways for additional products and contract‑manufacturing opportunities.
• Management views the milestone as a significant competitive advantage that supports future revenue diversification and growth.

Key Details

• FDA inspection confirmed full compliance with current Good Manufacturing Practices (cGMP) at Steri‑Med’s facility.
• Product Avaclyr® (ophthalmic ointment) will be marketed in the U.S. by Fera Pharmaceuticals LLC.
• Certification allows LSL Pharma to produce and potentially commercialize additional ophthalmic ointments for the U.S. market.
• CEO François Roberge highlighted that the approval provides direct access to a strong, long‑term U.S. market and positions the company for new partnerships and contract manufacturing.
• The company plans to expand manufacturing capacity to meet anticipated U.S. demand for specialized ophthalmic products.

Notable Quotes

“Obtaining FDA certification is a major achievement for LSL Pharma and a strong validation of the quality of our operations, manufacturing expertise, and our team's commitment to the highest regulatory standards,” – François Roberge, President & CEO.

“This approval provides us with direct access to the U.S. market which offers strong long‑term fundamentals, and positions the Company to pursue future growth through new partnerships and contract manufacturing opportunities in the United States.” – François Roberge.