Aurobindo Pharma Limited shares closed higher on Monday after the company announced receiving the approval from the United States Food and Drug Administration (USFDA) for Deflazacort Tablets.
In a filing to the stock exchanges, the company said that the US drug regulator has issued approval for Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg.
Deflazacort Tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and above.
The approved drug has an estimated market size of $67 million for the three months ending September 2023, according to PTC Therapeutics Inc, the company informed the bourses.
The company now has a total of 502 ANDA approvals including 20 tentative approvals from
USFDA.
Headquartered in Hyderabad, Aurobindo Pharma develops manufactures, and commercialises a wide range of generic pharmaceuticals, branded speciality pharmaceuticals and active pharmaceutical ingredients (APIs) globally in over 150 countries.
The company owns 25 manufacturing and packaging facilities, approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA.
Aurobindo Pharma shares showed strong consolidation on Monday, rallying over 3% in intraday trade after the company posted strong Q3 results.
The company's net profit soared nearly 91% year-on-year to ₹936.2 crore for the December quarter. Its revenue was up by 14.7% YoY to ₹7, 351.7 crore.
The pharma company’s operational performance also improved as the EBITDA margin expanded to 21.8% from 14.9% in the year-ago period.
Aurobindo Pharma shares closed higher at ₹1,017.95 apiece, up 1.59%, on BSE.
(Edited by : Ajay Vaishnav)