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Lupin Rises On USFDA Approval For Arthritis Drug

Lupin gained 1.08% to Rs 730.15 after the pharmaceutical major received US drug regulator’s approval for Leflunomide tablets.

Lupin in an exchange filing after market hours yesterday said that it has received US Food and Drug Administration (USFDA) approval for its Leflunomide tablets USP, 10 mg and 20 mg.

Leflunomide tablets are a generic equivalent of Arava tablets of Sanofi Aventis, used in treating active rheumatoid arthritis in adults. The product would be manufactured at Lupin’s Pithampur (Unit 1) facility, India.

According to IQVIA MAT December 2019, Leflunomide Tablets USP had annual sales of approximately $44 million in the US.

Last month, Lupin’s Vizag facility received five 483 observations from US drug regulator. Lupin received a communication from the USFDA classifying the inspection conducted at its Tarapur manufacturing (API) facility between 16 and 20 September 2019 as Official Action Indicated (OAI). The inspection at the Tarapur facility closed with three observations. The company does not believe that this inspection classification will have on impact on disruption of supplies or the existing revenues from operations of this facility.

Lupin is engaged in producing, developing and marketing a range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) across the world.

On a consolidated basis, the pharmaceutical company reported a net loss of Rs 127.07 crore in Q2 December 2019 compared with net profit of Rs 265.98 crore in Q2 December 2018. Net sales rose 10.4% to Rs 4296.90 crore in Q3 December 2019 over Q3 December 2018.

Lupin will announce its Q3 December 2019 result today, 6 February 2020.-Business Standard

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