Alembic Pharma share price is likely to see bullish activity after receiving a clean Form 483 with zero observations from the USFDA. This comes on the heels of the company's recent approval for Lamotrigine Extended-Release Tablets, used in the treatment of epilepsy. Moreover, strong financials have bolstered confidence in the stock, as Alembic reported both quarterly and yearly profit growth. Below, we detail the key aspects driving Alembic’s outlook, including regulatory updates, product approvals, and financial performance. The stock opened the trading session with moderate gains of 0.5 percent but we can expect stronger performance in today's session if broader market sentiment remains positive.

USFDA’s Clean Form 483 Inspection

Zero Observations: The USFDA issued a Form 483 with zero observations to Alembic Pharma, indicating no critical compliance issues in its manufacturing processes. This is a highly positive signal for investors, as regulatory clearance is essential for continued operations and product launches in the US market.

Recent Approval of Lamotrigine Extended-Release Tablets

Product Approval: Last week, the USFDA granted final approval for Alembic’s Lamotrigine Extended-Release Tablets USP in 200 mg, 250 mg, and 300 mg dosages.
Therapeutic Use: These tablets are indicated for adjunctive therapy in patients aged 13 years and older with generalized tonic-clonic seizures and partial-onset seizures, both with and without secondary generalization.
The approval enhances Alembic's portfolio of epilepsy treatments, reinforcing its commitment to expanding its product range in key therapeutic areas.

Strong Financial Performance

Q1 FY25 Earnings: For the quarter ending June 2024, Alembic Pharma posted an 11.3% year-on-year growth in net profit, reaching Rs 1,342 million compared to Rs 1,206 million in the same quarter last year. Net sales also increased by 5.1%, rising to Rs 15,617 million.

Annual Growth: In FY24, the company reported a massive 80.1% increase in net profit, surging to Rs 6,158 million from Rs 3,420 million in FY23. Revenue for the year grew by 10.2%, reaching Rs 62,286 million.

These financial results underscore the company’s resilience and ability to grow despite macroeconomic challenges, driven by solid product sales and cost efficiencies.

Company Background and Operations

Headquarters and Manufacturing: Alembic Pharma, headquartered in Vadodara, Gujarat, manufactures and markets a diverse array of pharmaceutical formulations for both domestic and international markets. The company’s production facilities are spread across Gujarat and Sikkim, catering to the Indian market and international generics.

Partnerships and Innovations: Alembic is committed to improving global access to healthcare through partnerships with leading pharmaceutical companies, leveraging its expertise in active pharmaceutical ingredients (APIs) and finished formulations.