Caplin Point Laboratories , a rapidly expanding pharmaceutical company with a strong presence in Latin America, has announced robust financial results for the second quarter of fiscal year 2026.

Financial Highlights

For Q2 FY26, Caplin Point reported:

• Revenue from operations of ₹534.04 crores, up 10.5% year-over-year (YoY)
• Total revenue of ₹564.41 crores, a 12.0% increase YoY
• Profit After Tax (PAT) of ₹160.23 crores, showing a significant 22.5% growth YoY
• EBITDA of ₹219.54 crores, up 18.3% YoY
• Earnings Per Share (EPS) of ₹20.32, compared to ₹17.22 in Q2 FY25

The company's performance for H1 FY26 was equally impressive:

• Total revenue reached ₹1,097.77 crores, up 11.9% YoY
• PAT increased by 21.6% to ₹310.99 crores
• US market revenue grew by 27% to ₹221 crores

Key Financial Metrics

Operational Highlights

• The company maintains a strong financial position with free cash reserves of ₹1,334 crores and total liquid assets of ₹2,358 crores as of September 30, 2025.
• Caplin Point's US subsidiary, Caplin Steriles Limited (CSL), continues to show profitable growth in both B2B and B2C segments.
• The company has expanded its presence in regulated markets, with 42 ANDA approvals and 10 more under review.
• Caplin Point has made significant progress in emerging markets, particularly in Latin America, with new product filings and market expansions.

Strategic Initiatives

• The company is expanding its manufacturing capabilities, including the development of new facilities for injectables and ophthalmics.
• Caplin Point is pursuing backward integration with its API unit in Vizag, aiming to be backward integrated for 60% of all ANDAs in the coming years.
• The company's "China 2.0" strategy is progressing, with partnerships granting access to over 130 approved ANDAs/MAs in the US and EU.

Management Commentary

Mr. C.C. Paarthipan, Chairman of Caplin Point Laboratories, stated, "Consistency has been the cornerstone of Caplin's journey. We are pleased to report another strong set of results, fully aligned with our long-term growth path and guidance. Our unwavering focus on cashflows, profitability, and revenue growth continues across all segments of the business, complemented by an equally strong commitment to compliance and governance."

Board Appointments

The company announced the appointment of Mr. Ashok Partheeban and Mr. Vivek Partheeban as Additional Directors and Vice-Chairmen, effective November 5, 2025. Additionally, Dr. K C John has been inducted as an Independent Director on the Board.

Caplin Point Laboratories continues to demonstrate strong growth and strategic expansion, positioning itself for sustained success in both emerging and regulated pharmaceutical markets.

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.