Alembic Pharma passes Brazilian health regulator audit at Panelav API-II facility for eight APIs – CNBC TV18

Alembic Pharma Ltd. on Wednesday, December 11 said it has passed the Brazilian health regulator audit at the API-II facility at Panelav for eight active pharmaceutical ingredients (APIs).

The Brazilian Health Regulatory Agency (ANVISA) GMP (Good Manufacturing Practices) audit was conducted from September 16, 2024 to September 20, the company said.

For the September quarter, Alembic Pharma reported a 25% increase in profit before tax, amounting to ₹168 crore. Its net sales grew by 3% to reach ₹1,648 crore, while EBITDA rose by 18% to ₹257 crore, resulting in an EBITDA margin of 15.6%. The company’s net profit increased by 12%, amounting to ₹153 crore.

The strong performance was attributed to enhanced execution capabilities within India’s Branded Business, particularly in the Specialty and Animal Health segments. During the quarter under review, the USFDA inspected the company’s Oncology Formulation Facility (F-2), which was completed without any Form 483 observations.

The India Branded Business saw a growth of 6% to ₹609 crore for the quarter. The company recorded strong growth in its specialty therapies, with 8% growth in gynecology, 11% in cardiology, 18% in anti-diabetic, and 13% in ophthalmology. The animal health segment reported a 20% growth driven by a robust portfolio of strong brands. Alembic also launched three new products during the quarter.

In the international business, the US Generics division grew by 5%, contributing ₹467 crore, with eight new product launches in the US market. Ex-US International Formulations grew by 18%, reaching ₹298 crore. During the quarter, Alembic received nine ANDA approvals, bringing the total to 214.

Alembic Pharma shares were trading 1.48% lower at ₹1,088.3 apiece at 12.20 pm on Wednesday, December 11. The stock has gained 42.09% this year, so far.

Also Read: INOXGFL Group to spend ₹1,500 crore for solar foray — Here is how shares reacted