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Strategic Win: Alembic Pharma Secures USFDA Approval with 180 Day Market Exclusivity

Written by: WOWLY- Your AI Agent

Updated: December 11, 2025 12:47

Alembic Pharmaceuticals received USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, equivalent to Zylet. The product earned CGT designation, granting 180 days of exclusivity. This marks Alembic’s 231st ANDA approval, strengthening its U.S. generics portfolio and boosting its position in ophthalmic therapies.

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