ALEMBIC : RECEIVES USFDA FINAL APPROVAL FOR VALGANCICLOVIR ORAL SOLUTION

• Final USFDA approval for ANDA of Valganciclovir for Oral Solution, 50 mg/mL • Approved ANDA is therapeutically equivalent to RLD Valcyte for Oral Solution 50 mg/mL of CHEPLAPHARM Arzneimittel GmbH • Product indicated for treatment of CMV retinitis in AIDS patients and prevention of CMV disease in high-risk kidney, heart or kidney-pancreas transplant patients • Alembic now has cumulative 247 ANDA approvals from USFDA, including 227 final and 20 tentative approvals

Alembic Pharmaceuticals Ltd

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