Gland Pharma Limited , a leading generic injectable-focused pharmaceutical company, has achieved significant milestones with recent approvals from the United States Food and Drug Administration (USFDA) for two important products.

Cangrelor Injection Approval

Gland Pharma received USFDA approval for its Abbreviated New Drug Application (ANDA) for Cangrelor Injection. This development positions the company to tap into a market with annual U.S. sales of approximately $122.00 million.

Product Details and Market Potential

Cangrelor Injection, approved in a 50mg/vial formulation, is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL, manufactured by Chiesi USA Inc. This injectable medication is indicated as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of:

• Periprocedural myocardial infarction (MI)
• Repeat coronary revascularization
• Stent thrombosis (ST)

These benefits apply to patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.

Norepinephrine Bitartrate Injection Approval

In addition to Cangrelor, Gland Pharma has also received USFDA approval for Norepinephrine Bitartrate in 5% Dextrose Injection. This approval covers two dosage strengths:

• 4 mg/250 mL (16 mcg/mL)
• 8 mg/250 mL (32 mcg/mL) Single-Dose Bags

The product is bioequivalent and therapeutically equivalent to Baxter Healthcare Corp's reference drug and is indicated to raise blood pressure in adult patients with severe, acute hypotension.

Market Potential and Exclusivity

According to IQVIA, Norepinephrine Bitartrate had U.S. sales of approximately $55.00 million for the twelve months ending June 2025. Importantly, Gland Pharma holds exclusive First-to-File status for this product and is eligible for 180 days of generic drug exclusivity.

Strategic Importance

These USFDA approvals align with Gland Pharma's strategy to expand its portfolio of complex injectables and strengthen its presence in the U.S. pharmaceutical market. The company's ability to successfully develop and gain approval for generic versions of these medications demonstrates its robust research and development capabilities and regulatory expertise.

Company's Growth Trajectory

Gland Pharma has been actively expanding its product pipeline and global footprint. The company's focus on injectable formulations, including complex generics, has been a key driver of its growth strategy. With these latest approvals, Gland Pharma reinforces its position as a significant player in the generic injectable space.

As Gland Pharma prepares to bring these new products to market, the pharmaceutical industry will be watching closely to see how these offerings impact the company's market share and financial performance in the competitive U.S. generic drug landscape.

A significant block trade of Gland Pharma shares took place on the National Stock Exchange (NSE) on Tuesday, coinciding with the company's announcement of robust first-quarter results.

Block Trade Details

Approximately 455,110 shares of Gland Pharma changed hands in a block deal valued at ₹91.12 crore. The transaction was executed at ₹2,002.20 per share, representing a substantial institutional interest in the pharmaceutical company's stock.

Q1 Financial Highlights

The block trade comes on the heels of Gland Pharma's impressive financial performance for the quarter ended June 30:

• Revenue from operations increased by 7% year-on-year to ₹15,056.00 million
• EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) surged by 39% to ₹3,678.00 million
• EBITDA margin improved significantly to 24%, up from 19% in the same quarter last year
• Profit After Tax (PAT) showed a remarkable 50% growth, reaching ₹2,155.00 million
• PAT margin expanded to 14%, compared to 10% in the previous year's corresponding quarter

Operational Performance

Gland Pharma's base business, excluding its Cenexi operations, demonstrated solid growth:

• Base business revenue grew by 3% year-on-year to ₹10,409.00 million
• EBITDA for the base business increased by 22% to ₹3,592.00 million
• EBITDA margin for the base business improved to 35%, up from 29% in the same quarter last year

Geographic Performance

The company reported mixed results across different markets:

Management Commentary

Srinivas Sadu, Executive Chairman of Gland Pharma, commented on the results: "We're off to a positive start this year with a growth in revenue and a significant jump in profitability, which was driven by a strong performance in our base business and a turnaround at Cenexi. These results show our strategic priorities are progressing and we are strengthening our capabilities, adding new capacity, and boosting R&D with complex products and key partnerships."

Shyamakant Giri, Chief Executive Officer, added: "This quarter's performance, with improved margins and Cenexi achieving EBITDA break even, reinforces the progress we are making in delivering our long-term vision. By enhancing our base business, investing in differentiated products, and driving operational efficiencies, we are positioning ourselves for sustained growth."

Business Highlights

• R&D expenses for the quarter were ₹460.00 million, representing 4.4% of revenue
• The company launched 12 new molecules in regulated markets during the quarter
• One ANDA was filed and nine were approved, bringing the total to 372 ANDA filings in the U.S. (325 approved, 47 pending)
• Gland Pharma is expanding its GLP-1/Pen/cartridge capacity from ~40 million to 140 million units

The block trade, coupled with Gland Pharma's strong quarterly performance, underscores investor confidence in the company's growth trajectory and operational efficiency improvements.