Gland Pharma Limited, a prominent generic injectable and ophthalmic-focused pharmaceutical company, has achieved a significant milestone in its product portfolio expansion. The company has received approval from the United States Food and Drug Administration (USFDA) for its Vasopressin in 5% Dextrose Injection, marking a strategic entry into a market with substantial potential.

Key Approval Details

The USFDA has granted approval for Gland Pharma's Abbreviated New Drug Application (ANDA) for two variants of Vasopressin in 5% Dextrose Injection:

• Full approval for 40 Units per 100 mL (0.40 Units per mL) Ready-to-Use (RTU) Vials
• Tentative approval for 20 Units per 100 mL (0.20 Units per mL) RTU Vials

Product Significance

Vasopressin in 5% Dextrose Injection is a critical medication used to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite receiving fluids and catecholamines. This approval positions Gland Pharma to compete in a market segment with significant demand.

Market Opportunity

According to IQVIA data cited in the company's announcement, the U.S. market for this product recorded sales of approximately $45.00 million. This represents a substantial opportunity for Gland Pharma to capture market share and boost its revenue in the injectable pharmaceuticals segment.

Therapeutic Equivalence

The approved product is both bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection, manufactured by PH Health Limited. This equivalence is crucial for generic drug approvals and market acceptance.

Company Background

Gland Pharma, established in 1978 in Hyderabad, has evolved from a contract manufacturer of small-volume liquid parenteral products to become one of the largest injectable-focused companies globally. The company operates primarily under a business-to-business (B2B) model and has established a strong presence in over 60 countries, including key markets such as the United States, Europe, Canada, Australia, and India.

Future Outlook

This USFDA approval strengthens Gland Pharma's position in the competitive generic injectables market. As the company continues to expand its product portfolio and global footprint, such approvals are likely to play a crucial role in driving growth and enhancing shareholder value.

Investors and industry observers will be keenly watching how Gland Pharma leverages this approval to capture market share and contribute to its financial performance in the coming quarters.

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.