ALEMBIC PHARMACEUTICALS

Alembic Pharmaceuticals receives USFDA approval for Lamotrigine Extended-Release Tablets, indicated for adjunctive therapy for seizures. The tablets are therapeutically equivalent to GlaxoSmithKline's Lamictal XR, with an estimated market size of $163 million.

Alembic Pharmaceuticals received FDA approval for Lamotrigine extended-release tablets, 200 mg, 250 mg, and 300 mg, for treating seizures. The tablets are equivalent to GlaxoSmithKline's Lamictal XR and have a market size of $163 million.

Alembic Pharmaceuticals shares rose 4% on Oct 3 after receiving US FDA approval for Lamotrigine Extended-Release Tablets, a generic version of GlaxoSmithKline's Lamictal XR. The shares have jumped 56% over the past 12 months, outperforming the Nifty 50 index.

Lupin's Pithampur Unit-1 received Form 483 from USFDA with 3 observations after inspection. Alembic Pharmaceuticals received an EIR from USFDA for its oral solid formulation facility inspection.

Alembic Pharmaceuticals received USFDA approval for Paliperidone Extended-Release Tablets (1.5 mg, 3 mg, 6 mg, 9 mg), equivalent to Janssen's Invega. Used for schizophrenia and schizoaffective disorder, the market size is $48 million by June 2024. Alembic has 215 total ANDA approvals from the USFDA.

Alembic Pharmaceuticals received USFDA approval for its ANDA Albendazole Tablets USP, 200 mg, equivalent to Impax's LAlbenza Tablets. Indicated for neurocysticercosis and cystic hydatid disease, Alembic now has 214 total ANDA approvals from USFDA.