Gland Pharma Limited has secured approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). The approval was announced on January 07, 2026, pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Product Details and Therapeutic Equivalence

The approved product demonstrates therapeutic equivalence to the reference listed drug (RLD), Pataday Once Daily Relief, 0.7%, manufactured by Alcon Laboratories Inc. This ophthalmic solution is specifically indicated for the treatment of ocular itching associated with allergic conjunctivitis, offering patients an effective over-the-counter option for relief from allergy-related eye symptoms.

Market Response and Stock Performance

Following the announcement, Gland Pharma's shares demonstrated positive market response, closing at ₹1,710.00 on the NSE on January 7, representing an increase of ₹16.70 or 0.99%. This market reaction reflects investor confidence in the company's regulatory achievements and expansion in the US ophthalmic market.

Company Background and Operations

Gland Pharma Limited operates as a generic injectable and ophthalmic-focused pharmaceutical company, established in 1978 in Hyderabad. The company has evolved from a contract manufacturer of small-volume liquid parenteral products to become one of the largest injectable-focused companies globally.

The company maintains a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other international markets. Gland Pharma operates primarily under a business-to-business (B2B) model with an established track record in developing, manufacturing, and marketing sterile injectables.

Strategic Impact and Market Position

This USFDA approval strengthens Gland Pharma's position in the ophthalmic solutions segment and expands its approved product portfolio for the highly regulated US market. The milestone underscores the company's focus on developing high-quality ophthalmic formulations and expanding its presence in the global pharmaceutical sector.

The approval allows Gland Pharma to market a therapeutically equivalent product in the competitive US over-the-counter ophthalmic market, potentially generating additional revenue streams from this specialized therapeutic area.

Product Portfolio and Manufacturing Capabilities

The company's manufacturing portfolio encompasses a comprehensive range of injectable products including vials and ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology products, and ophthalmic solutions. Gland Pharma holds the distinction of pioneering Heparin technology in India, demonstrating its innovation capabilities in specialized pharmaceutical manufacturing.

Gland Pharma Limited, a leading injectable-focused pharmaceutical company, reported a 6% year-on-year increase in consolidated revenue for the second quarter of fiscal year 2026 (Q2FY26). The company's performance was driven by strong growth in regulated markets and improved profitability in its core business.

Key Financial Highlights

• For H1FY26, consolidated revenue was INR 29,925.00 million, reflecting a 7% increase over H1FY25.
• H1FY26 EBITDA was INR 6,817.00 million with a margin of 23%, up from 20% in the previous year.

Market Performance

United States

• U.S. revenue rose 8% year-on-year to INR 8,005.00 million for Q2FY26.
• Seven new molecules were launched in Q2, including Daptomycin-RTU and Sumatriptan.
• The company's top 20 molecules grew by 9% on a year-to-date basis, while the top 10 molecules grew by 14%.

Other Regulated Markets

• Revenue from Europe, Canada, Australia, and New Zealand reached INR 1,574.00 million for H1FY26, growing 18% year-on-year.

Rest of World (ROW)

• ROW market contributed INR 1,635.00 million in Q2FY26 and INR 3,168.00 million in H1FY26.
• Own product sales revenue in ROW grew by 19% in H1FY26, while tech transfer and CMO product revenue declined by 53%.

Cenexi Performance

Cenexi, Gland Pharma's European subsidiary, showed improvement despite a planned shutdown in Q2:

• Reported revenue of EUR 88.00 million for H1FY26, marking a 10% year-over-year growth in euro terms.
• EBITDA losses decreased to EUR 5.00 million from EUR 11.00 million in the previous year.
• The company remains confident in achieving EBITDA breakeven for Cenexi in Q3FY26.

Strategic Initiatives and Future Outlook

Gland Pharma is focusing on several strategic initiatives to drive growth and improve profitability:

1. Expanding into complex and differentiated portfolios, including long-acting injectables, hormones, and peptides.
2. Investing in R&D (5.8% of revenue in Q2) to develop complex injectables and next-generation delivery systems.
3. Increasing cartridge fill/finish capacity from 40 million to 140 million units to support GLP-1 and insulin programs.
4. Expanding biologic CDMO capacity from 8 KL to 23 KL to support biosimilar and biologic fill/finish opportunities.
5. Optimizing product mix and deepening integration with Cenexi to capture operational synergies.

The company maintains its guidance for mid-teen consolidated revenue growth for FY26, supported by new product launches and continued improvement at Cenexi.

Management Commentary

Srinivas Sadu, Executive Chairman of Gland Pharma, stated, "Our strategic focus is clear to build Gland Pharma into a global innovation-led injectable and CDMO company that consistently delivers growth, margin expansion and superior capital efficiency."

Shyamakant Giri, CEO, added, "With our current momentum, we are confident in robust growth in the second half of FY '26."

As Gland Pharma continues to expand its capabilities in complex injectables and CDMO services, the company appears well-positioned to capitalize on growth opportunities in the global pharmaceutical market.