Shares of Alembic Pharmaceuticals rose nearly 5% on Thursday after the company received final approval from the US Food and Drug Administration (USFDA) for Lamotrigine Extended-Release tablets, which are primarily used in the management of certain types of seizures.

This approval adds to Alembic Pharma’s growing portfolio, which now includes 216 ANDA approvals from the USFDA, comprising 188 final approvals and 28 tentative approvals.

These tablets are the therapeutic equivalent to the reference drug Lamictal XR, manufactured by GlaxoSmithKline LLC (GSK), Vadodara-based Alembic Pharma said in a stock exchange filing.

Lamotrigine Extended-Release tablets, in strengths of 200 mg, 250 mg, and 300 mg, are used as adjunctive therapy for patients aged 13 and older with primary generalised tonic-clonic seizures and partial-onset seizures, with or without secondary generalisation.

The drug is also approved for monotherapy conversion in patients with partial-onset seizures who are currently on a single antiepileptic drug.

According to IQVIA data, the market size for Lamotrigine Extended-Release tablets in these strengths is estimated to be around $163 million for the 12 months ended June 2024.

Headquartered in India, Alembic Pharma has a strong presence in the global pharmaceutical market and operates research and manufacturing facilities approved by major regulatory bodies, including the USFDA.

In addition to its global presence, Alembic Pharma is also a leader in branded generics in India, supported by a large marketing team of over 5,000 professionals.

In August, Alembic Pharma stated that it is gearing up for aggressive expansion of its US operations, with plans to launch over 20 products during financial year 2025.

According to Managing Director Pranav Amin, the company had a slow start with just two product launches in the first quarter, but it has since secured 11 new approvals, paving the way for a faster rollout in the competitive US market.

Shares of Alembic Pharma were trading 4.9% higher at ₹1,250. The stock is up 63% so far in 2024.