Announcements

  • 15 May 18

    Jubilant receives ANDA approval for Niacin Extended-Release Tablets USP

Noida (UP), India, Tuesday, May 15, 2018

Jubilant Life Sciences Ltd, an integrated global Pharmaceutical and Life Sciences Company, has announced that Jubilant Pharma Limited, a material wholly owned subsidiary of the Company, through one of its wholly owned subsidiaries, has received Abbreviated New Drug Application (ANDA) final approval for Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1,000 mg, the generic version of Niaspan® of AbbVie, which is indicated to reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL -C in patients with primary hyperlipidemia and mixed dyslipidemia thereby reducing the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia.

This is the first approval that we have received from the USFDA during the current financial year. As on March 31, 2018, Jubilant had a total of 94 ANDAs for Oral Solids filed in the US, of which 59 had been approved and 12 Sterile (Injectables & Ophthlamics) filings, of which 10 had been approved.

About Jubilant Life Sciences Limited

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 through 6 USFDA approved manufacturing facilities in India, USA and Canada and a network of over 50 radio-pharmacies in the US. 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 proprietary in-house innovation & collaborative research and partnership for out-licensing through 3 world class research centres in India and USA. Jubilant Life Sciences Limited has a team of around 7,600 multicultural people across the globe and is committed to deliver value to its customers across over 100 countries. The Company is well recognized as a ‘Partner of Choice’ by leading pharmaceuticals and life sciences companies globally. For more info: www.jubl.com.

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