Alembic Pharma Secures USFDA Approval Boosting Share Price

The Impact of USFDA Approval on Alembic Pharma

Shares of Alembic Pharmaceuticals rose nearly 5% on Thursday after the company received final approval from the US Food and Drug Administration for Lamotrigine Extended-Release tablets, 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.

Lamotrigine Extended-Release tablets, available in strengths of 200 mg, 250 mg, and 300 mg, are utilized as adjunctive therapy for patients aged 13 and older with primary generalized tonic-clonic seizures and partial-onset seizures. The drug is also approved for monotherapy conversion in patients currently on a single antiepileptic.

Market Potential for Lamotrigine

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

Alembic Pharma's Global Presence

Headquartered in India, Alembic Pharma has a significant presence in the global pharmaceutical arena, supported by research and manufacturing facilities accredited by major regulatory bodies, including the USFDA. Additionally, Alembic Pharma is a leader in branded generics within India, backed by an extensive marketing team of over 5,000 professionals.

Future Plans and Market Strategy

In August, Alembic Pharma announced aggressive plans to expand its US operations, aiming to launch over 20 products during the financial year 2025. Despite an initial slow start with just two product launches in the first quarter, the company has since achieved 11 new approvals, enabling a quicker rollout in the competitive US market. Shares of Alembic Pharma are currently trading up 4.9% at ₹1,250, reflecting a 63% increase since the beginning of 2024.