Alembic Pharmaceuticals receives USDA final approval for Paliperidone Extended-Release Tablets

The company reported that the approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Invega Extended-Release tablets which belong to Janssen Pharmaceuticals.

Alembic stated that Paliperidone extended-release tablets are an atypical antipsychotic agent that is used for the treatment of schizophrenia. Further, the drug is also used to treat schizoaffective disorders as a monotherapy and as an adjunct to mood stabiliser or antidepressants.

Citing IQVIA’s data for the period ended June 2024, the company reported that Paliperidone Extended-Release tablets 1.5 mg, 3 mg, 6 mg, and 9 mg market has an estimated market size of $48 million.

Earlier this month, Alembic Pharmaceuticals announced that it had received final approval from the USFDA for Albendazole Tablets USP, 200 mg. The company stated that the approved ANDA is therapeutically equivalent to the RLD, LAlbenza tablets, 200 mg which belong to Impax Laboratories. The tablets are used for the treatment of parenchymal neurocysticercosis and cystic hydatid disease of the liver, lung, and peritoneum.

For the quarter ended June 30, 2024, Alembic Pharmaceuticals net profit rose 12% year-on-year (YoY) to ₹135 crore. The company reported a 5% YoY rise in net sales to ₹1,562 crore during the quarter.

The company’s earnings before interest, taxes, depreciation, and amortisation (EBITDA) climbed higher by 14% YoY to ₹239 crore.

The company has a total of 215 ANDA approvals, out of which, 187 have received final approval and 28 have received tentative approvals from the USFDA.

Shares of the company have risen by nearly 41% since the beginning of the year. The stock has gained over 83% in the past year.

Shares of the company have risen by nearly 55% since the beginning of the year. The stock has gained over 56% in the past year.