Alembic Pharmaceuticals Secures USFDA Final Approval for Haloperidol Tablets

Alembic Pharmaceuticals Secures USFDA Final Approval for Haloperidol Tablets​

Alembic Pharmaceuticals Limited has received final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) covering Haloperidol Tablets. The tablets, available in strengths of 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg, have been approved by the USFDA.

The newly approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Haldol Tablets, supplied by Ortho McNeil Pharmaceutical.

Haloperidol Tablets are indicated for the management of manifestations of psychotic disorders. They are also prescribed for controlling tics and vocal utterances associated with Tourette's Disorder in both children and adults.

According to IQVIA, these Haloperidol Tablets carry an estimated market size of US$ 27 million over a twelve-month period ending March 2026.

Company Overview and Pipeline​

This approval contributes to Alembic’s growing portfolio of ANDA successes. The company has accumulated a cumulative total of 240 ANDA approvals from the USFDA, which includes 221 final approvals and 19 tentative approvals.

Alembic Pharmaceuticals Limited is described as a vertically integrated research and development pharmaceutical company, operating since 1907. Headquartered in India, the publicly listed company manufactures and markets generic pharmaceutical products globally. Alembic's facilities are approved by regulatory authorities in several developed countries, including the USFDA. The company is noted as a leader in branded generics in India.

APLLTD Stock Price Movement​

As of 10:52 AM, shares of Alembic Pharmaceuticals Limited are slipping by 0.49% in live trading, currently priced at ₹733.90 as the stock sheds ₹3.65. The equity has seen 40,580 shares traded so far today.