Lupin Ltd, a leading pharmaceutical company, witnessed a surge in its share price following the approval of its chlorpromazine hydrochloride tablets by the United States Food and Drug Administration (USFDA). Lupin's subsidiary, Lupin Inc., received the green light to market the generic equivalent of Upsher-Smith Laboratories' chlorpromazine hydrochloride tablets. The tablets will be manufactured at Lupin's facility in Somerset, New Jersey. With an estimated annual sales value of USD 45 million in the US, this product holds significant potential for Lupin in the market.
Despite the positive news, it's worth noting that on July 12, Lupin's Nagpur Oral Solid Dosage facility received two observations with Form-483 from the USFDA following an inspection conducted between July 3 and July 11, 2023. However, Lupin has expressed confidence in addressing the observations promptly and upholding quality and compliance standards across all its facilities.
In a separate development, Lupin received the establishment inspection report (EIR) from the USFDA for its Pithampur Unit-2 manufacturing facility, which specializes in oral solids and ophthalmic dosage forms. The facility was classified as Voluntary Action Indicated (VAI) following the inspection conducted from March 21 to March 29, 2023.
As of the latest trading session, Lupin's stock price showed positive momentum, trading at Rs 934.00 on the BSE, representing a 0.36% increase. The stock recently hit a 52-week high of Rs 943.10, while its 52-week low stands at Rs 602.80. Despite being slightly below the 52-week high, Lupin's stock remains considerably higher than its low point, reflecting investor confidence.
The USFDA approval for Lupin's chlorpromazine hydrochloride tablets is expected to bolster the company's growth prospects in the US market and reinforce its position as a prominent player in the pharmaceutical industry.
