Kwality Pharmaceuticals has successfully filed and got the approval for Leuprorelin Acetate 11.25 mg vial powder and solvent for injectable suspension as a site variation in Greece, marking its entry into the European Markets. Kwality Pharma will supply the first three validation batches in December and after complete Quality Control Analysis, will start regular supplies from January 2025 onwards.
This strategic CDMO arrangement is projected to generate around $3 million of yearly sales, with distribution set to begin in the 4th quarter of this fiscal year. Furthermore, the company has plans to add remaining strengths of the same in the product portfolio with the same buyer as well. This marks a pivotal step in its strategy to introduce products in highly regulated markets.
Kwality Pharmaceuticals (formerly Kwality Pharmaceuticals) is a pharmaceutical formation company.