Alembic Pharma gets USFDA nod for Bosentan tablets

Alembic Pharmaceuticals today informed the bourses that it has received a final USFDA approval for its Abbreviated New Drug Application (ANDA) Bosentan tablets, 62.5 mg and 125 mg.

The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product-Tracleer tablets, 62.5 mg, and 125 mg of Actelion Pharmaceuticals Limited.

Bosentan is used to treat Pulmonary Arterial Hypertension (PAH) that is, high blood pressure in the vessels, which carries blood to the lungs in adults and children of age 3 years and above.

The company recently came up with the results for the quarter ended on December 31, 2019. The consolidated revenue for Q3FY20 came in at Rs 1,209.13 crore as against Rs 1,018.15 crore in the corresponding quarter last year, registering 18.8 per cent YoY increase. The EBITDA for the quarter grew by 34.2 per cent YoY to Rs 325.05 crore as against Rs 242.23 crore in the corresponding quarter last year, with a corresponding margin expansion of 309 bps. EBITDA margin for the quarter stood at 26.9 per cent. The PAT for the quarter came in at Rs 227.68 crore as against Rs 170.75 crore in the corresponding quarter last year, with YoY increase of 33.3 per cent.

The revenue mix for Q3FY20 stood at API- 15 per cent, Branded Formulations- 30 per cent and Generics- 55 per cent. International formulations business grew 48 per cent YoY to Rs 664 crore. The India formulations business came in at Rs 368 crore for the quarter as against Rs 365 crore last year. The company has received eight ANDA approvals during the quarter along with 110 cumulative ANDA approvals.

Today, the stock jumped nearly 2 per cent and made an intraday high of Rs 600 on BSE.