LSL Pharma Group announced that it has secured certification from the FDA for its ophthalmic ointment manufacturing activities.
The ophthalmic product Avaclyrâ, manufactured by LSL Pharma's subsidiary, Steri-Med Pharma, and to be marketed by U.S.-based Fera Pharmaceuticals, has received FDA approval for commercialization in the United States. The certification of the Steri-Med's manufacturing site allows LSL Pharma to manufacture and potentially commercialize additional ophthalmic ointment products for commercialization in the U.S. market.
The certification follows a successful FDA inspection of Steri-Med's facility, confirming full compliance with current Good Manufacturing Practices (cGMP). The Company believes this regulatory milestone significantly strengthens its competitive positioning, enhances future revenue diversification, and establishes a clear pathway for sustainable growth and long-term value creation for shareholders.
"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 François 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.
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