Lupin rises after USFDA clears Aurangabad facility

Pharmaceutical major Lupin gained 0.86% to Rs 724 after the US drug regulator completed inspection of the drug major's Aurangabad facility with zero observation.

Lupin announced on Monday (17 February) the successful completion of an inspection carried out by the US Food and Drug Administration (USFDA) at its Aurangabad facility. The inspection was carried out between 10 and 14 February 2020. The inspection concluded without any observation.

Commenting on the outcome of the inspection, Nilesh Gupta, managing director, Lupin said, "We are encouraged with the successful inspection at our Aurangabad facility. We continue to enhance our standards of quality and compliance across our manufacturing operations and remain committed to uphold the highest quality standards across all our sites."

Meanwhile, on Friday (14 February), Lupin announced the launch of Moxifloxacin Ophthalmic Solution USP, 0.5%, having received an approval from the USFDA earlier. The product would be manufactured at Lupin's Pithampur (Unit-II) facility in India. Moxifloxacin Ophthalmic Solution USP, 0.5% is the AT2-rated generic equivalent of Moxeza of Novartis. It is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of certain organisms. The drug had an annual sales of approximately $10 million in the US. (IQVIA MAT December 2019).

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. The firm offers products in the cardiovascular, diabetology, asthma, pediatrics, central nervous system, gastro-intestinal, anti-infectives and non-steroidal anti-inflammatory drug therapy areas.

On a consolidated basis, Lupin reported net loss of Rs 835 crore in Q3 December 2019 as against net loss of Rs 151.75 crore in Q3 December 2018. Net sales declined 2.75% to Rs 3716.09 crore in Q3 December 2019 over Q3 December 2018.

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