Alembic Pharma Gets USFDA Approval For Haloperidol Tablets; Shares Rise

Mumbai, June 5: Alembic Pharmaceuticals said it received final approval from the US Food and Drug Administration (USFDA) for Haloperidol Tablets USP in strengths of 1 mg, 2 mg, 5 mg, 10 mg and 20 mg.

The company said in an exchange filing on Friday, that the approval was granted for its abbreviated new drug application (ANDA) for the product, which is therapeutically equivalent to the reference listed drug Haldol Tablets of Ortho McNeil Pharmaceuticals.

Haloperidol Tablets are indicated for the management of psychotic disorders and control of tics and vocal utterances associated with Tourette’s Disorder.

According to IQVIA data cited by the company, the product has an estimated market size of about $27 million for the twelve months ended March 2026.

Alembic said it now has a cumulative total of 240 ANDA approvals from the USFDA, including 221 final approvals and 19 tentative approvals.

Stock Market Snapshot

Alembic Pharma share price traded in positive territory following the regulatory update.

The stock traded at ₹742.15 on the NSE, up 0.62% or ₹4.60 as of 12:49 PM IST on June 5, 2026, according to market data.

The counter recovered from early session lows and moved above ₹740 during midday trade as investors tracked developments in the company’s US generics business.

Company Expands US Generics Portfolio

Alembic Pharmaceuticals operates as a vertically integrated pharmaceutical company with a presence across branded and generic formulations.

The company manufactures and markets generic pharmaceutical products globally, with several facilities approved by international regulatory authorities including the USFDA.

Source:

• https://www.nseindia.com/get-quote/equity/APLLTD/Alembic-Pharmaceuticals-Limited
• https://nsearchives.nseindia.com/corporate/APLLTD_05062026105038_Intimation_to_SE_Press_Release_FA.pdf