Caplin Point Laboratories announced that its subsidiary Caplin Steriles Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sodium Phosphates Injection USP. The approval was announced on February 24, 2026, through a press release filed under Regulation 30 with stock exchanges.

Product Specifications and Market Opportunity

The USFDA approval covers Sodium Phosphates Injection USP in three different strengths: 15mM P/5mL, 45mM P/15mL and 150mM P/50mL (3mM P/mL) Single-Dose Vials. This generic product is a therapeutic equivalent version of the Reference Listed Drug from Hospira, Inc., USA.

Medical Applications

Sodium Phosphates Injection is indicated as a source of phosphorus for addition to large volume intravenous fluids, primarily to prevent or correct hypophosphatemia in patients with restricted or no oral intake. The product also serves as an additive for preparing specific parenteral fluid formulas when standard electrolyte or nutrient solutions cannot meet patient needs.

Company Portfolio Expansion

Caplin Steriles Limited has developed and filed 54 ANDAs in the USA independently and with partners, achieving 51 approvals including acquired ANDAs. The subsidiary is currently working on a portfolio of 55+ simple and complex Injectable and Ophthalmic products planned for filing over the next 4 years.

Caplin Point Laboratories has delivered robust financial performance for the quarter ended December 31, 2025, demonstrating strong growth across key metrics. The pharmaceutical company announced its Q3FY26 results with significant improvements in revenue, profitability, and operational efficiency across both emerging and regulated markets.

Strong Revenue Growth Across Segments

The company reported consolidated revenue from operations of ₹542.8 crores for Q3FY26, representing a solid 10.1% year-on-year growth compared to ₹493.0 crores in Q3FY25. Total revenue including other income reached ₹576.5 crores, up 9.9% from ₹524.3 crores in the corresponding quarter last year.

Impressive Profitability Performance

Caplin Point Laboratories reported consolidated net profit of ₹165.9 crores for Q3FY26, marking an 18.4% increase compared to ₹140.1 crores in Q3FY25. The company's EBITDA reached ₹223.4 crores, representing a substantial 15.3% year-on-year growth with EBITDA margin improving to 38.7% from 36.9% in the previous year.

Nine-Month Performance Highlights

For the nine months ended December 31, 2025, the company achieved total revenue of ₹1,674.2 crores, up 11.2% from ₹1,505.7 crores in the corresponding period last year. Nine-month net profit reached ₹476.9 crores, representing a robust 20.5% year-on-year growth. Basic earnings per share increased significantly to ₹61.98 for nine months compared to ₹51.82 in the previous year.

Strategic Business Developments

The company continues to strengthen its market position with significant developments across emerging and regulated markets. In emerging markets, Caplin Point has secured new tender orders worth $25 million in Central American markets and received approvals for 25 products in Mexico with a pipeline of 100+ products planned for filing. The company has also acquired industrial land in Mexico for establishing manufacturing and packaging facilities.

In regulated markets, Caplin Steriles Limited maintains strong performance with 55 ANDAs approved in the US. The company's US subsidiary, Caplin Steriles USA Inc, has achieved revenue of $8.7 million since inception with 29 products launched under its own label. Free cash reserves stand at ₹1,381 crores with total liquid assets of ₹2,459 crores, providing strong financial flexibility for growth initiatives.

Earnings Call Audio Recording Available

Following the announcement of Q3FY26 results, Caplin Point Laboratories has made available the audio recording of its earnings call held on February 05, 2026. The company informed both BSE Limited and National Stock Exchange of India about the availability of the earnings call recording on its official website, providing stakeholders with access to detailed discussions about the quarterly performance and strategic outlook.