The drug, which is also sold as Indocin by Iroko in the US, is a nonsteroidal anti-inflammatory drug used for the treatment of moderate to severe inflammation and reduce pain.
“This is the seventh approval that we have received from the USFDA during the current financial year,” the company said.
As on June 30, 2017, Jubilant had a total of 84 ANDAs for Oral Solids filed in the US, of which 53 had been approved, it added.
Jubilant Life Sciences Limited is an integrated global pharmaceutical and life sciences company engaged in Pharmaceuticals, Life Science Ingredients and Drug Discovery Solutions.
The Pharmaceuticals segment, through its wholly owned subsidiary Jubilant Pharma Limited, is engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile and Non-sterile products.
The company has 6 USFDA approved manufacturing facilities in India, USA and Canada.
The Life Science Ingredients segment, is engaged in Specialty Intermediates, Nutritional Products and Life Science Chemicals through 5 manufacturing facilities in India.
The Drug Discovery Solutions segment provides in-house innovation & collaborative research and partnership for out-licensing and has three research centres in India and USA.
The company employs over 6,700 people.