LSL obtains FDA certification for ophthalmic ointments

Executive Summary

• LSL Pharma Group’s subsidiary, Steri-Med Pharma Inc., has obtained U.S. FDA certification for the manufacturing of ophthalmic ointments, confirming compliance with current good manufacturing practices (cGMP).
• This certification specifically covers the manufacturing of Avaclyra, which is marketed in the U.S. by Fera Pharmaceuticals LLC, and establishes a pathway for LSL Pharma to manufacture and commercialize additional ophthalmic ointment products in the U.S. market.
• The company views this regulatory milestone as a strategic advantage that strengthens its competitive positioning, enhances revenue diversification, and supports future growth through new partnerships and contract manufacturing opportunities.

Key Details

• Regulatory Body: United States Food and Drug Administration (FDA).
• Certified Entity: Steri-Med Pharma Inc. (subsidiary of LSL Pharma Group Inc.).
• Certified Activity: Manufacturing of ophthalmic ointments.
• Specific Product: Avaclyra (manufactured by Steri-Med, marketed by Fera Pharmaceuticals LLC).
• Compliance Standard: Confirmed full compliance with current good manufacturing practices (cGMP) following a successful FDA inspection.
• Strategic Impact:
  • Provides direct access to the U.S. market.
  • Enables the manufacture and potential commercialization of additional ophthalmic ointment products beyond Avaclyra.
  • Positions the company to pursue future growth through new partnerships and contract manufacturing opportunities.
• Future Plans: LSL Pharma plans to significantly expand its manufacturing capacity to support U.S. market demand for specialized ophthalmic product development and manufacturing projects.

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," said Francois Roberge, president and chief executive officer of LSL Pharma.
• "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," Mr. Roberge added.