FDA approves hypertension generic
MUMBAI, India — Jubilant Life Sciences announced that Jubilant Pharma, a material wholly owned subsidiary of the company, through one of its wholly owned subsidiaries, has received Food and Drug Administration Abbreviated New Drug Application final approval for amlodipine and olmesartan medoxomil Tablets 5mg/20mg, 5mg/40mg, 10mg/20mg and 10mg/40mg, the generic version of Daiichi Sankyo’s Azor.
The drug is used for the treatment of hypertension. According to Jubilant, the FDA approval is the third the company has received during its current financial year. As of Dec. 31, Jubilant Life Sciences had a total of 73 ANDAs for oral solids filed in the United States, of which 49 have been approved.
India-based Jubilant Life Sciences 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, is engaged in manufacture and supply of APIs, solid dosage formulations, radiopharmaceuticals, allergy therapy products and contract manufacturing of sterile and non-sterile products via six FDA-approved manufacturing facilities in India, the USA and Canada.