Alembic Pharma USFDA nod for Haloperidol; ANDAs hit 240

What Alembic Pharmaceuticals announced

Alembic Pharmaceuticals said it has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Haloperidol Tablets USP. The approval covers five strengths: 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg. The company positioned the update as part of its broader US generics pipeline, where approvals and inspections are tracked closely by investors.

The announcement adds to a series of USFDA-related disclosures from Alembic over the past few quarters, spanning approvals, tentative approvals, and plant compliance updates. While the company did not provide launch timelines in the provided information, the regulatory clearance is a key milestone in enabling marketing of a generic product in the US, subject to commercial decisions.

Reference product and therapeutic equivalence

Alembic said the approved Haloperidol Tablets USP are therapeutically equivalent to the reference listed drug (RLD), Haldol Tablets. The RLD is from Ortho McNeil Pharmaceutical, as cited in the company’s disclosure.

Therapeutic equivalence to the RLD is a standard reference point in ANDA approvals and is used to describe that the generic product meets the required criteria for substitutability as described in the regulatory filing. Alembic’s statement focused on this equivalence and the dosage strengths included in the approval.

Alembic’s cumulative USFDA ANDA approval count

Following the Haloperidol approval, Alembic Pharmaceuticals said it has a cumulative total of 240 ANDA approvals from the USFDA. This total comprises 221 final approvals and 19 tentative approvals.

The company’s cumulative numbers have been referenced in other updates too. In a separate announcement related to Paliperidone extended-release tablets, Alembic had stated a cumulative total of 215 ANDA approvals, comprising 187 final approvals and 28 tentative approvals. In another summary covering approvals between 2024 and 2025, the company’s cumulative ANDA approvals were described as increasing from 219 to 223 over that period, including both final and tentative approvals. These disclosures indicate that Alembic has periodically updated the market as its running total changes with each new decision from the regulator.

Another recent approval: Lamotrigine orally disintegrating tablets

In a separate disclosure from New Delhi, Alembic said it received final USFDA approval to market a generic medication for seizures. The approval covers Lamotrigine orally disintegrating tablets in multiple strengths, filed under an ANDA.

Alembic said its approved ANDA is therapeutically equivalent to GlaxoSmithKline LLC’s reference listed drug product, Lamictal orally disintegrating tablets. The company also detailed the indications described for lamotrigine: it is indicated as adjunctive therapy in patients aged two years and older for partial-onset seizures, primary generalised tonic-clonic seizures, and generalised seizures of Lennox-Gastaut syndrome. It is also indicated for conversion to monotherapy in adults aged 16 years and older with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug.

Paliperidone extended-release tablets approval for schizophrenia

Alembic also disclosed final USFDA approval for its generic version of Paliperidone extended-release tablets. The approved strengths cited were 1.5 mg, 3 mg, 6 mg, and 9 mg.

The company said the approved ANDA is therapeutically equivalent to the reference listed drug product Invega extended-release tablets of the same strengths from Janssen Pharmaceuticals, Inc. Alembic stated paliperidone extended-release tablets are indicated for the treatment of schizophrenia and are also indicated for the treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilisers and/or antidepressants.

Compliance update: EIR for API plants in Gujarat

In another USFDA-related update, Alembic said it received an Establishment Inspection Report (EIR) from the USFDA for its API-I and API-II plants at Panelav in Gujarat. EIR receipts are closely watched because they indicate closure of an inspection cycle for a facility, based on the regulator’s processes.

The company’s update highlighted the site and the scope as API units. No additional operational changes, timelines, or follow-on actions were specified in the provided information.

Approvals referenced across FY24 quarters

Alembic has also summarised approvals across financial quarters. One update stated the company received USFDA approvals on eight ANDAs in Q3FY24. Another stated Alembic received USFDA approvals on six ANDAs during Q2FY24.

The lists cited in the provided information included products such as Chlorpromazine Hydrochloride Tablets USP (10 mg, 25 mg, 50 mg, 100 mg, and 200 mg), Brimonidine Tartrate Ophthalmic Solution (0.1 per cent), and Guanfacine Extended-Release Tablets. A separate detail included in the provided material described chlorpromazine’s uses, including managing symptoms of psychotic disorders and treatment of schizophrenia, among other uses listed.

Select timeline of approvals and tentative approvals (2024-2025)

A separate summary described multiple approvals and tentative approvals between 2024 and 2025. In December 2024, Alembic received tentative approval for Olopatadine Hydrochloride Ophthalmic Solution 0.7%, a generic version of Pataday Once Daily Relief. In May 2025, it received final approval for Rivaroxaban tablets (2.5 mg, 10 mg, 15 mg, and 20 mg), therapeutically equivalent to Xarelto, and also for Amlodipine and Atorvastatin tablets in multiple strengths, equivalent to Caduet.

In June 2025, Alembic received final approval for Doxorubicin Hydrochloride Liposome Injection (20 mg/10 mL and 50 mg/25 mL), a generic version of Doxil, indicated for certain cancers. In August 2025, it obtained final approval for Tretinoin Cream USP 0.025%, equivalent to Retin-A, for the treatment of acne vulgaris.

Macitentan approval and market coverage detail

The provided information also referenced that in August 2025, Alembic secured final approval for Macitentan Tablets (10 mg), described as a generic version of Johnson and Johnson’s Opsumit, used to treat pulmonary arterial hypertension.

The same material stated the approval covers 18 markets across Asia-Pacific and EMEA, with India and Vietnam identified as priority markets. Separately, a market update noted shares of Alembic Pharmaceuticals Ltd rose as much as 2.8% to 999 rupees in connection with the Macitentan approval.

Key facts at a glance

Snapshot: selected approvals referenced in the material

Market impact and what investors typically track

The most direct market move cited in the provided information was a rise of up to 2.8% in Alembic Pharmaceuticals Ltd shares to 999 rupees following the Macitentan approval.

Across such announcements, investors typically focus on the number of approvals, the pace of approvals across quarters, and the status of manufacturing facilities. Alembic’s disclosures include both product-level approvals and the EIR received for its API plants at Panelav, Gujarat. The cumulative count of ANDA approvals, including the split between final and tentative approvals, is also a frequently reported metric in its updates.

Why the Haloperidol approval matters in the broader sequence

The Haloperidol final approval adds another product to Alembic’s stream of USFDA decisions. The company has recently reported approvals across multiple therapy areas based on the products mentioned in the provided information, including neurology (lamotrigine), psychiatry-related indications (paliperidone, chlorpromazine uses listed), ophthalmology products, and other categories.

Just as importantly for tracking purposes, the company has now reported a cumulative 240 ANDA approvals, including 221 final and 19 tentative approvals. This helps contextualise the approval as part of a continuing pipeline rather than a one-off event.

Conclusion

Alembic Pharmaceuticals’ final USFDA approval for Haloperidol Tablets USP in five strengths, equivalent to Haldol Tablets, pushes its cumulative ANDA approvals to 240, with 221 final and 19 tentative approvals. The approval sits alongside other recent USFDA outcomes cited in the provided information, including final approvals for lamotrigine orally disintegrating tablets and paliperidone extended-release tablets, and an EIR for its API plants at Panelav in Gujarat. The next set of updates from the company is likely to come through further regulatory filings on approvals, tentative approvals, or additional inspection outcomes, as seen in its recent pattern of disclosures.