Alembic Pharma Gets USFDA Nod for Paliperidone ER Tablets

On September 27, 2024, Alembic Pharmaceuticals announced that it had been given final approval from the US Food & Drug Administration (USFDA) for its Paliperidone Extended-Release Tablets in strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg. This approval is for a generic version of Invega Extended-Release Tablets developed by Janssen Pharmaceuticals. Paliperidone is used to cure schizophrenia and schizoaffective disorder, either on its own or along with mood stabilizers or antidepressants.

The market for Paliperidone Extended-Release Tablets is estimated to be worth around $48 million for the year ending June 2024, according to IQVIA. With this approval, Alembic now has 215 ANDA approvals, which includes 187 final and 28 tentative approvals from the USFDA.

Financial Highlights

In Q1 results, the company showed a 5.09% increase in revenue and an 11.42% rise in profit compared to the same period last year.

Compared to the last quarter, revenue grew by 2.95%, but profit dropped by 24.6%. Selling, general, and administrative expenses decreased by 5.49% quarter-on-quarter but were up 9.08% year-on-year.

Operating income fell by 11.95% from the last quarter but increased by 26.63% compared to last year. The earnings per share (EPS) for Q1 stood at ₹6.84, reflecting an 11.4% year-on-year growth. Alembic Pharmaceuticals has delivered strong returns, gaining 0.12% in the past week, 22.55% over the last 6 months, and 59.86% year-to-date.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited is a research-driven pharmaceutical company that has been a key player in healthcare since 1907. Based in India and publicly listed, Alembic produces and sells generic medicines worldwide. Its advanced research and manufacturing facilities are approved by regulators in several developed countries, including the USFDA. Alembic is also a leader in branded generics in India, with a marketing team of over 5,000 people promoting its well-known products to doctors and patients.

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