Kwality Pharma Gains Approval for Leuprorelin Acetate Injectable Suspension in Greece

Key Insights

• Kwality Pharmaceuticals Limited (KPL) has secured approval in Greece for its Leuprorelin Acetate 11.25 mg injectable suspension, marking its entry into the European market.
• The company plans to supply initial validation batches by December, with regular supplies commencing from January 2025 after thorough quality control analysis.
• This strategic CDMO arrangement is expected to generate approximately USD 3 million in annual sales, with distribution starting in the fourth quarter of this fiscal year.

Kwality Pharmaceuticals Limited (KPL) has announced that it has received approval for its Leuprorelin Acetate 11.25 mg vial powder and solvent for injectable suspension in Greece. This approval signifies KPL's entry into the European market.

The company is set to supply the first three validation batches in December. Following complete Quality Control Analysis, regular supplies are scheduled to commence from January 2025 onwards. This strategic CDMO arrangement is projected to generate around USD 3 million in yearly sales, with distribution set to begin in the 4th Quarter of this fiscal year. Furthermore, there are plans to add remaining strengths of the same in the product portfolio with the same buyer as well.

This approval marks a pivotal step in the company's strategy to introduce its products in highly regulated markets.