Pharmaceutical giant Lupin Ltd. announced on Tuesday that the US health agency had given the go-ahead for the marketing of its generic Pirfenidone capsules, which are used to treat the lung condition known as idiopathic pulmonary fibrosis.
The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Pirfenidone capsules of 267 mg strength, Lupin said in a regulatory filing.
The drug is the generic equivalent of Esbriet Capsules, 267 mg of Hoffmann La Roche Inc.
This product will be manufactured at Lupin’s Pithampur facility in India, it added.
Pirfenidone capsules had estimated annual sales of USD 95 million in the US, Lupin said citing IQVIA MAT June 2023 data.
Currently, shares of the company were trading 0.30% up at Rs. 1,101. As per the company filing, total company revenue grew by 28% YoY from Rs. 3,743.8 to Rs. 4,814 Cr in Q1 FY24 and the company reported a net profit of Rs. 4,52.2 Cr in Q1 FY24 against loss of 86.8 Cr in Q1 FY23.
Lupin Ltd. (Lupin) develops and produces biotechnology goods, active pharmaceutical ingredients (APIs), and generic and branded formulations. It has knowledge of cardiovascular, asthma, diabetes management, paediatrics, gastro-intestinal, anti-infectives, nonsteroidal anti-inflammatory medications (NSAIDs), anti-TB, and cephalosporins. It also has knowledge of the central nervous system.
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