Hyderabad-based Gland Pharma Limited, a well-established name in the injectable and ophthalmic-focused generic pharmaceutical space, has added another feather to its cap by receiving a significant approval from the United States Food and Drug Administration (USFDA). The regulatory body has approved Gland Pharma’s Abbreviated New Drug Application (ANDA) for Angiotensin II Acetate Injection 2.5 mg/mL, a generic version of GIAPREZA®, originally developed by La Jolla Pharma LLC.

This latest milestone not only enhances Gland’s product portfolio but also gives it a competitive edge in the US pharmaceutical market.

Product Overview and Therapeutic Significance

Angiotensin II Acetate Injection is a critical care injectable used to raise blood pressure in adult patients suffering from septic or other types of distributive shock. These are serious medical conditions where the patient’s blood vessels become too dilated, causing dangerously low blood pressure and risking organ failure.

The approval marks Gland Pharma’s entry into a niche segment within emergency critical care treatment, helping address a vital medical need.

USFDA Approval and Generic Equivalence

The approval confirms that Gland Pharma’s injectable is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), GIAPREZA®. This ensures:

• Same efficacy

• Same dosage form

• Same administration route

• Comparable safety profile

This equivalence is crucial for doctors, hospitals, and patients to trust the generic as a reliable and cost-effective alternative to the original product.

First-to-File Status and Exclusivity Advantage

A major advantage for Gland Pharma in this approval is its First-to-File (FTF) status. Under the Hatch-Waxman Act, the first company to file an ANDA for a generic drug referencing a brand drug is rewarded with 180 days of marketing exclusivity. This means:

• Gland Pharma is the only generic version allowed in the US market for six months.

• During this time, the company can capture significant market share and generate higher revenues before other generic versions arrive.

This exclusivity window offers a strong commercial opportunity for Gland Pharma to leverage.

Market Potential and Revenue Outlook

According to leading data analytics firm IQVIA, the US market for Angiotensin II Acetate Injection was worth approximately USD 58 million in sales for the 12 months ending March 2025.

While the figure might not be as massive as other blockbuster categories, the critical care nature and hospital-based use of this drug mean that volumes are lower but margins are higher—especially during the 180-day exclusivity period.

The drug's inclusion also diversifies Gland Pharma’s therapeutic footprint in the US.

Strategic Relevance for Gland Pharma

This USFDA approval:

• Strengthens Gland’s US presence, its key market

• Adds to its regulated injectable portfolio, a core segment of the company’s business

• Supports growth in revenue and margins for FY26

• Reinforces Gland’s track record as a high-quality generic injectable manufacturer

This aligns with Gland Pharma’s broader strategy of focusing on complex injectables, sterile products, and first-to-market opportunities in key geographies like the US, Canada, and the EU.

Competitive Edge in Injectable Market

The injectable drug market is less crowded than the solid oral dosage form segment, due to the complexity of manufacturing and stringent regulatory compliance. Gland Pharma has consistently invested in:

• Sterile manufacturing facilities

• USFDA-approved plants

• Research and development (R&D) for complex products

This infrastructure allows it to deliver high-quality, timely ANDA filings and maintain its first-mover advantage.

Gland’s Regulatory Track Record

Gland Pharma has consistently built a strong regulatory portfolio, with numerous approvals and pending applications across:

• Parenteral drugs

• Ophthalmics

• Complex injectables like suspensions, emulsions, and depot injections

The latest USFDA nod adds to its growing library of high-value generics, validating its regulatory expertise and compliance framework.

Financial Implications

The short-term impact of this product is expected to reflect in the:

• Topline growth during the exclusivity period

• Margin expansion due to limited competition

• Better capacity utilization of manufacturing units

Given the USD 58 million market size, Gland could potentially capture a significant chunk during its exclusive window, helping offset pressures from other competitive markets.

Broader Implications for Indian Pharma

The approval once again shines a spotlight on India’s role as a global generics powerhouse, particularly in injectable therapeutics. It also:

• Enhances India's credibility as a regulatory-compliant exporter

• Showcases India's technical expertise in sterile drug manufacturing

• Encourages other Indian companies to focus on First-to-File ANDAs and niche formulations

Gland Pharma, through this approval, continues to be a beacon of quality and precision in Indian pharmaceutical exports.

Conclusion

Gland Pharma’s USFDA approval for Angiotensin II Acetate Injection, along with its 180-day exclusivity, represents a key win for the company, both strategically and financially. With a growing injectable portfolio, robust manufacturing capabilities, and regulatory excellence, Gland Pharma is well-positioned to strengthen its global footprint, deliver value to stakeholders, and provide affordable alternatives in critical care treatment.

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