In the early trading session on April 10, Lupin witnessed a 1% increase following the introduction of its inaugural generic rendition of Oracea (doxycycline capsules) in the US market.
At 9:32 am, Lupin’s shares were quoted at Rs 1,621.30, marking a gain of Rs 16.25, or 1.01%, on the Bombay Stock Exchange (BSE).
According to a press release by the company, Lupin has officially launched the first generic variant of Oracea (doxycycline capsules, 40 mg) in the United States subsequent to obtaining approval from the US Food and Drug Administration (US FDA).
Doxycycline capsules are primarily indicated for treating inflammatory lesions such as papules and pustules associated with rosacea in adult patients.
Lupin has initiated a recall of 26,352 bottles of Rifampin capsules from the US market, a medication commonly used in the treatment of tuberculosis, due to being identified as sub-potent.
These capsules, manufactured at Lupin’s Aurangabad plant and distributed by its US subsidiary, were found to be below the expected potency levels, prompting the recall which began on March 21. The US Food and Drug Administration (FDA) classified this recall as a Class II recall, indicating a situation where use of the affected product may cause temporary or medically reversible adverse health consequences.
In addition to this recall, Lupin faced scrutiny in March when it received a Form 483 from the US FDA following an inspection of its Aurangabad facility from March 6 to 15. The Form 483 is issued when FDA investigators observe any conditions that may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts.
Despite these setbacks, Lupin’s share price has displayed considerable volatility. On March 11, 2024, the stock soared to a 52-week high of Rs 1,703.80. In contrast, it reached a 52-week low of Rs 655.75 on April 17, 2023. Presently, the stock is trading 4.84% below its 52-week high and 147.24% above its 52-week low, indicating significant fluctuations over the past year.
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