Lupin Vizag facility gets US regulator's inspection report with no observations

Lupin share price: Lupin shares gave up initial gains in volatile trade on Monday amid the drug maker said the US Food and Drug Administration (FDA) completed inspection at its API manufacturing facility located in Visakhapatnam, Andhra Pradesh with no observations. The Lupin stock briefly traded in the green, rising to as high as Rs 833.9 apiece on BSE, after the development before turning flat.

The US drug regulator its inspection, carried out from March 6 to March 10, at the Indian company's Vizag facility with a "no action indicated", according to a company statement.

“We are happy to have received the EIR for our Vizag facility from the US FDA," said Nilesh Gupta, Managing Director, Lupin. “We remain committed to ensuring the high quality of our products and ensuring the safety of our manufacturing processes," he said.

In a separate development, Lupin launched Thiamine Hydrochloride Injection USP, a drug used in treating thiamine deficiency, in the US market.

Lupin announced the rollout of the drug in 200 mg/2 mL (100 mg/mL) multiple-dose vials, after its alliance partner, Caplin Steriles, received an approval for its ANDA from the US drug regulator.

The Thiamine Hydrochloride Injection USP has estimated annual sales of $35 million in the US.

The development follows the Mumbai-based pharma company's launch of antiretroviral medication Darunavir, sold under the brand name Prezista, in the US market in early June. The drug, used in the treatment and prevention of HIV/AIDS, has estimated annual sales of $308 million in the US.

Lupin financials

Lupin posted a consolidated net profit of Rs 236 crore for the January-March quarter as against a net loss of Rs 518 crore for the corresponding period a year ago. Its sales jumped 12 per cent on a year-on-year basis to Rs 4,330.3 crore, according to a regulatory filing.

Lupin shares: Past performance

Lupin shares have grown nearly 38 per cent in value in the past one year, as against a rise of 22 per cent in the headline Nifty index.