Gland Pharma Zoomed Over 3% After Receiving USFDA Approval

Gland Pharma Limited, a leading manufacturer of generic injectable medications, has secured a significant win with the approval of Eribulin Mesylate Injection by the US Food and Drug Administration (USFDA). This milestone marks the first generic version of this vital treatment to reach the US market, positioning Gland Pharma to capitalise on a substantial opportunity.

The approved product, Eribulin Mesylate Injection (0.5 mg/mL Single Dose Vial), caters to a critical need in the treatment of metastatic breast cancer. According to IQVIA, the US market for this specific medication holds an estimated value of USD 92 million for the twelve months ending February 2024. With Gland Pharma being the first generic entrant, they are poised to capture a significant share of this market upon launch.

The upcoming launch, planned for the near future through their established marketing partner network, will further strengthen Gland Pharma’s position in the US market. This approval signifies their commitment to developing and delivering high-quality generic injectables that address unmet medical needs.

Furthermore, the success with Eribulin Mesylate Injection highlights Gland Pharma’s collaborative approach to drug development. The company co-developed this complex injectable with Orbicular Pharmaceutical Technologies Private Limited, showcasing its expertise in partnering with other industry leaders to bring innovative generic medications to patients.

This USFDA approval for Eribulin Mesylate Injection is a major win for Gland Pharma. It strengthens its product portfolio and positions it as a frontrunner in the generic injectable space.

During Q3 FY2024, the company reported consolidated sales of ₹15,452 million, indicating a 13% quarter-on-quarter increase and a 65% year-on-year increase. The company achieved a consolidated EBITDA of ₹3,557 million and a consolidated net profit of ₹1,919 million.

Looking Ahead

Gland Pharma Limited will continue to face issues with operational performance in the near term. This will lead the business to rebalance its capacity and shift certain products to different lines.

About Gland Pharma Limited

Incorporated in 1978, Gland Pharma Limited has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become one of the largest injectable-focused companies, with a global footprint across 60 countries. On April 08, 2024, the shares of the company opened at ₹1,785.00 and touched the day high of ₹1,852.00 at 10:28 AM.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.