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.

Caplin Point Laboratories , a rapidly expanding pharmaceutical company with a strong presence in Latin America, has announced impressive financial results for the first quarter of fiscal year 2026 (Q1 FY26). The company's performance demonstrates significant growth across key financial metrics, underlining its strong market position and operational efficiency.

Financial Highlights

Caplin Point reported a consolidated total revenue of ₹533.40 crores for Q1 FY26, marking an 11.7% increase from ₹477.50 crores in the same quarter last year. The company's revenue from operations grew by 11.2% year-over-year, reaching ₹510.20 crores.

The company's profitability saw substantial improvement:

• Gross profit increased by 15.2% to ₹315.00 crores, with the gross margin expanding to 61.7% from 59.6% in Q1 FY25.
• EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) crossed the ₹200 crore mark, growing by 17.9% to ₹200.90 crores. The EBITDA margin improved to 37.7% from 35.7% in the corresponding quarter of the previous year.
• Net profit after tax surged by 20.7% to ₹150.80 crores, compared to ₹124.90 crores in Q1 FY25.
• Basic earnings per share (EPS) increased by 23.1% to ₹20.10, up from ₹16.32 in the same period last year.

Operational Performance

Caplin Point's performance was driven by strong growth across its business segments:

Emerging Markets

• The company strengthened its presence in Latin America with a new warehouse in Chile, positioning itself well in both tender and private markets with over 120 product registrations.
• In Mexico, the company has filed 35+ products, with 17 approvals received and a pipeline of 80+ products to be filed over the next 12 months.
• Caplin Point won tenders worth US$7.60 million in a key Central American market, to be supplied within Q2 and Q3 of FY26.

US and Regulated Markets

• Caplin Steriles Limited (CSL) reported robust growth in both B2B and B2C segments.
• The company currently has 38 ANDAs approved and 13 under review, setting the stage for strong growth in the coming quarters.
• Caplin Steriles USA Inc (CSU), the company's front-end in the US, achieved revenue of US$3.20 million within 8 months of operations, reaching profitability in its first year.

Strategic Initiatives

Caplin Point is implementing several strategic initiatives to drive future growth:

• Initiating a "China 2.0" strategy, focusing on partnerships for Peptides, Biosimilars, and Complex products for Latin American and Regulated markets.
• Expanding manufacturing capabilities with ongoing construction of an Oncology API site near Chennai and plans for onshore manufacturing in Mexico and Guatemala.
• Exploring land/plant acquisitions in the US for potential warehousing, packaging, and manufacturing operations.
• Targeting the filing of 7 Pre-Filled Syringe products within the next 12 months, addressing a niche segment with limited competition.

Financial Position

As of June 30, 2025, Caplin Point maintained a strong financial position with free cash reserves of ₹1,237.00 crores and total liquid assets of ₹2,207.00 crores. The company's asset-light model and focus on cash generation continue to strengthen its balance sheet.

Management Commentary

Mr. C.C. Paarthipan, Chairman of Caplin Point Laboratories, commented on the performance: "We're putting in place the right building blocks for both Emerging Markets and Regulated markets. We're making good progress with finalizing partners and also filing dossiers in our new key target markets of Mexico, Chile, USA, etc. We're also aiming to gradually onshore some strategic manufacturing at important locations in Latin America and US, and taking the first steps of acquiring land/buildings for the same."

Dividend Announcement

The Board of Directors has recommended a final dividend of ₹3.00 per equity share (150%) for the financial year 2024-25, subject to shareholder approval at the upcoming Annual General Meeting. This brings the total dividend for FY 2024-25 to ₹6.00 per equity share (300%) of the face value of ₹2.00 each, including the interim dividend paid earlier.

With its strong financial performance, strategic growth initiatives, and commitment to shareholder returns, Caplin Point Laboratories continues to demonstrate its potential as a leading player in the pharmaceutical industry.