Lupin Limited , a prominent pharmaceutical company, has achieved a significant milestone in its product portfolio expansion. The company has received approval from the U.S. Food and Drug Administration (FDA) for its Risperidone Long-Acting Injectable Suspension, marking a notable advancement in its drug development efforts.

Key Highlights

• FDA Approval: Lupin has successfully obtained U.S. FDA approval for Risperidone Long-Acting Injectable Suspension.
• Platform Milestone: This approval represents the first product from Nanomi's Long-Acting Injectable (LAI) platform.
• Exclusivity Period: The approval comes with a 180-day Competitive Generic Therapy (CGT) exclusivity.
• Market Potential: The estimated annual sales for this product in the U.S. market stand at USD 190.00 million.

Strategic Importance

The approval of Risperidone Long-Acting Injectable Suspension is a significant achievement for Lupin, showcasing the company's capabilities in developing complex pharmaceutical products. This injectable formulation adds to Lupin's growing portfolio of specialty and complex generic medications.

Market Impact

With the 180-day CGT exclusivity, Lupin gains a competitive edge in the market for this particular formulation. This period of exclusivity could potentially translate into substantial revenue generation for the company, given the estimated annual U.S. market sales of USD 190.00 million for the product.

Technological Advancement

The successful development and approval of this product highlight Lupin's progress in utilizing Nanomi's LAI platform. This achievement may pave the way for future developments in long-acting injectable formulations, potentially opening new avenues for drug delivery and treatment options.

Looking Ahead

As Lupin prepares to launch Risperidone Long-Acting Injectable Suspension in the U.S. market, investors and industry observers will be keen to see how this new product contributes to the company's financial performance and market position in the coming quarters.

This FDA approval underscores Lupin's commitment to innovation and its ability to navigate the complex regulatory landscape of the pharmaceutical industry, potentially strengthening its position in the global generic drug market.

Lupin Limited , a leading pharmaceutical company, has issued a postal ballot notice seeking shareholder approval for two significant resolutions that could shape the company's leadership and executive compensation structure.

Independent Director Re-appointment

The first resolution proposes the re-appointment of Mr. Mark D. McDade as an Independent Director for a second five-year term, from January 28, 2026, to January 27, 2031. This appointment requires a special resolution as Mr. McDade will exceed 75 years of age during his tenure.

Mr. McDade, who has been serving on Lupin's board since January 2021, brings over 37 years of biopharmaceutical experience to the table. His expertise spans corporate governance, leadership, healthcare technology, and risk management, among other crucial areas.

Managing Director Remuneration Revision

The second resolution seeks approval for a substantial revision in the remuneration of Managing Director Nilesh D. Gupta, effective October 1, 2025. The proposed changes include:

• An increase in basic salary to ₹72.00 million per annum
• Total fixed cost rising to approximately ₹109.70 million
• Performance incentives of up to 100% of fixed cost

This revision comes after a peer benchmarking analysis revealed that Mr. Gupta's current compensation falls in the bottom 20% of comparable pharmaceutical companies.

Company Performance Under Current Leadership

Under Mr. Gupta's stewardship, Lupin has seen significant growth:

Voting Details

Shareholders can cast their votes through remote e-voting from August 27 to September 25, 2025. The results are expected to be announced by September 29, 2025.

These resolutions reflect Lupin's efforts to retain experienced leadership and align executive compensation with industry standards, potentially positioning the company for continued growth in the competitive pharmaceutical sector.