Lupin Shares to Gain Focus on Thursday Following US FDA Approval of Dapagliflozin and Metformin Tablets

Lupin's Shares to Attract Investor Attention Following US FDA Approval

Pharma major Lupin's shares are likely to be on investors' radar during Thursday's session, April 9, as the company announced the approval of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in the United States. The company, in its regulatory filing on Wednesday, said it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in strengths of 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg.

The USFDA-approved product is bioequivalent to Xigduo XR and will be used for the same indications as per the approved label. This approval comes on the heels of the company's announcement earlier this month regarding the completion of its acquisition of VISUfarma B.V., a leading European specialty pharmaceutical company focused on ophthalmology, from GHO Capital Partners LLP (GHO).

The acquisition marks the company's ongoing strategy to expand its specialty care portfolio and strengthen its presence in Europe. The company further stated that VISUfarma enhances its ability to address the growing global demand for innovative eye care solutions, driven by an ageing population and the rising burden of diabetes-related eye complications.

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Founded in 2016 through the combination of the Italian company Visufarma SpA and the European commercial activities of Nicox SA, VISUfarma is a specialty pharmaceutical company focused on ophthalmology. It generated €53 million in revenue in 2025 across Italy, the UK, Spain, Germany, France, and certain international markets, according to the company's regulatory filing dated April 1.

Lupin's shares have been maintaining a winning streak, ending each of the last six months in the green, resulting in a 22% gain. The stock had earlier witnessed a similar bull run between April 2023 and August 2024, during which it gained 263%. In terms of yearly performance, the stock delivered a negative return of 10.45% in 2025 after delivering positive returns in the preceding two consecutive years.