Caplin Point Laboratories , a prominent player in the pharmaceutical industry, has made significant strides in expanding its product portfolio and strengthening its position in the U.S. market. The company recently announced two major developments that are set to bolster its growth trajectory.

USFDA Approval for Nicardipine Hydrochloride Injection

Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection. This approval covers two formulations:

• 20 mg/200 mL (0.1 mg/mL) Single-dose Infusion Bags
• 40 mg/200 mL (0.2 mg/mL) Single-dose Infusion Bags

This generic version is therapeutically equivalent to the Reference Listed Drug (RLD) from Hikma International Pharmaceuticals LLC. Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable.

According to IQVIA™ (IMS Health) data, the U.S. market for Nicardipine Hydrochloride in Sodium Chloride Injection was approximately $68.00 million for the 12-month period ending August 2025.

Strategic Acquisition of ANDA Products

In a move to further expand its product offerings, Caplin Point Laboratories has acquired four approved ANDA products from third parties. These acquisitions, valued at approximately $121.00 million, include:

The collective market size for these products in the U.S. is approximately $121.00 million for the 12-month period ending August 2025, based on IQVIA™ data. Caplin Point Laboratories plans to introduce these products in the U.S. and other markets in 2026.

Company Outlook

These developments underscore Caplin Point Laboratories' commitment to expanding its presence in the U.S. pharmaceutical market. The USFDA approval for Nicardipine Hydrochloride Injection and the strategic acquisition of four ANDA products are expected to contribute significantly to the company's growth in the coming years.

Caplin Steriles Limited, which spearheaded the USFDA approval, has been making steady progress in the U.S. market. The company has developed and filed 52 ANDAs in the U.S., either independently or with partners, and has received 42 approvals to date. Additionally, Caplin Steriles is working on a portfolio of over 40 simple and complex Injectable and Ophthalmic products, which it plans to file over the next four years.

These recent developments align with Caplin Point Laboratories' broader strategy of expanding its product portfolio and strengthening its position in key markets. As the company continues to focus on research, development, and strategic acquisitions, investors and industry observers will be keenly watching its performance in the coming quarters.

Conclusion

Caplin Point Laboratories' recent USFDA approval and strategic acquisitions demonstrate the company's commitment to growth and innovation in the pharmaceutical sector. These moves are expected to enhance the company's product offerings and potentially boost its market share in the U.S. and other key markets. As always, investors should consider these developments in the context of broader market trends and the company's overall financial performance when making investment decisions.

Caplin Point Laboratories , through its subsidiary Caplin Steriles, has achieved a significant milestone in its pharmaceutical journey. The company has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Milrinone Lactate in 5% Dextrose Injection.

Product Details

The approved product, Milrinone Lactate in 5% Dextrose Injection, comes in two strengths:

• 20 mg/100 mL (0.2 mg/mL)
• 40 mg/200 mL (0.2 mg/mL)

These single-dose infusion bags are a generic therapeutic equivalent version of the Reference Listed Drug (RLD) PRIMACOR in Dextrose 5%, manufactured by Sanofi Aventis US LLC.

Market Potential

According to IQVIA™ (IMS Health) data, the US market for Milrinone Lactate in 5% Dextrose Injection generated approximately $11.00 million in sales for the 12-month period ending July 2025. This approval opens up a significant market opportunity for Caplin Steriles.

Medical Application

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. This approval enhances Caplin Steriles' portfolio in the critical care segment.

Company Growth and Portfolio

Caplin Steriles has been making steady progress in the US pharmaceutical market. The company has developed and filed 51 ANDAs (including two ANDAs acquired in April 2025) in the USA, either independently or with partners. Out of these, 40 have received approvals so far.

Looking ahead, Caplin Steriles is working on a portfolio of over 40 simple and complex injectable and ophthalmic products, which it plans to file over the next four years. The company's expansion isn't limited to the US market; it has multiple products filed and approved in non-US markets such as Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, and Saudi Arabia.

About Caplin Point Laboratories

Caplin Point Laboratories Limited, the parent company of Caplin Steriles, has established itself as a fast-growing pharmaceutical company with a unique business model primarily serving emerging markets in Latin America and Africa. The company boasts state-of-the-art manufacturing facilities that produce a complete range of finished dosage forms.

Caplin Point has demonstrated consistent high-quality growth in cash flows, profitability, and revenues over the past 15 years. Its achievements have been recognized internationally, with the company appearing on Forbes' "Asia's 200 Best Under a Billion" list seven times in the last ten years.

This latest USFDA approval for Milrinone Lactate Injection reinforces Caplin Steriles' growing presence in the US generic drug market and underscores the company's commitment to expanding its product portfolio in critical care medications.