CHENNAI: Shares of Vadodara-based drug maker Alembic Pharmaceuticals jumped over 12% after the company received approval from the US Food and Drug Administration (USFDA) for its generic version of Doxorubicin Hydrochloride Liposome injection. This drug is used in cancer treatment and is part of a high-value and competitive segment in the US pharmaceutical market. The approval marks another important step in Alembic’s efforts to expand its US generics portfolio.
One of India's pioneering pharma companies, Alembic has been steadily building its presence in the US market, with more than 180 Abbreviated New Drug Applications (ANDAs) filed and over 120 already approved. This latest approval is expected to add to its revenue stream and improve market visibility, especially in the oncology segment.
The company, which was previously focused mainly on the domestic market through its active pharmaceutical ingredient (API) and formulation businesses—primarily in antibiotics—has only recently begun actively expanding into international markets.
"While the stock gained strongly on this development, it comes shortly after Alembic reported its financial results for the fourth quarter of FY25. The company posted a 17% year-on-year increase in revenue, reaching around ₹1,770 crore. However, its net profit declined by about 12% to ₹157 crore due to increased investment in R&D, manufacturing capacity, and regulatory compliance. Despite the dip in profit, the company’s EBITDA rose 9% to ₹286 crore, showing that its core operations remain strong.
The US business continues to be a major growth driver for Alembic. In the fourth quarter, US sales contributed around ₹521 crore, with strong year-on-year growth. The company has also been actively launching new products and investing in new facilities --in Jarod and Karakhadi -- to support future growth.
Investor reaction to the USFDA approval has been positive, as the market sees this as a sign of Alembic’s growing capabilities in complex generics. Although recent profit numbers were slightly lower, the long-term outlook remains promising with more product launches and international market expansion expected.
The sharp rise in Alembic Pharma’s share price reflects investor confidence in its US growth strategy and the commercial potential of its newly approved cancer drug.