Announcements

  • 30 Jan 18

    Jubilant receives ANDA approval for Clonidine Hydrochloride Extended-Release Tablets

Noida (UP), India, Tuesday, January 30, 2018

Jubilant Pharma Limited, a material wholly owned subsidiary of Jubilant Life Sciences Ltd, through one of its wholly owned subsidiaries, has received Abbreviated New Drug Application (ANDA) final approval for Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg, the generic version of KapvayĀ® of Concordia, which is used for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

This is the eighth approval that we have received from the USFDA during the current financial year. As on December 31, 2017, Jubilant had a total of 86 ANDAs for Oral Solids filed in the US, of which 56 had been approved and 12 Injectable filings, of which 10 had been approved.

About Jubilant Pharma Limited

Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile and Non Sterile products. JPL has 6 USFDA approved manufacturing facilities in India, US and Canada and R&D centres in India and Canada. The Company has a team of around 3,500 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally.

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