Caplin point laboratories subsidiary Caplin Steriles Limited has secured final approval from the United States Food and Drug Administration (USFDA) for its Methylprednisolone Acetate Injectable Suspension, marking another milestone in the company's US market expansion strategy.

USFDA Approval Details

The approval covers the Abbreviated New Drug Application (ANDA) for Methylprednisolone Acetate Injectable Suspension USP in two strengths - 40mg/mL and 80mg/mL Single Dose vials. This generic version serves as a therapeutic equivalent to the Reference Listed Drug (RLD) DEPO-MEDROL manufactured by Pfizer Inc., USA.

Therapeutic Applications

Methylprednisolone Acetate Injectable Suspension functions primarily as an anti-inflammatory treatment across diverse medical conditions. The medication addresses multiple therapeutic areas including:

• Allergic states and dermatologic diseases
• Endocrine disorders and gastrointestinal diseases
• Hematologic diseases and ophthalmic conditions
• Respiratory diseases and rheumatic disorders

According to IQVIA™ (IMS Health) data, the approved product had US sales of approximately $57.4 million for the 12-month period ending November 2025, representing a substantial market opportunity for Caplin Steriles.

Company Portfolio and Capabilities

Caplin Steriles Limited operates as a fast-growing sterile product manufacturing company with approvals from multiple regulatory agencies including US FDA, EU-GMP, ANVISA and INVIMA. The subsidiary has demonstrated strong development capabilities with 53 ANDAs filed in the USA independently and through partnerships, achieving 50 approvals including acquired ANDAs.

The company maintains an active pipeline of 55+ simple and complex Injectable and Ophthalmic products planned for filing over the next 4 years. Additionally, Caplin Steriles has secured multiple product approvals in non-US markets across various countries.

Corporate Structure and Recognition

Caplin Point Laboratories Limited operates with a unique business model focused predominantly on emerging markets in Latin America and Africa. The parent company has achieved consistent high-quality growth in cash flows, profitability and revenues over 15 years. Notable recognition includes appearing on Forbes "Asia's 200 Best Under a Billion" list seven times in the last 10 years, along with receiving "The Emerging Company of 2018" and "Business Excellence Award for 2019" from Economic Times.

The group structure includes Caplin One Labs Limited (COL), another subsidiary operating an oncology unit in Kakkalur in its second year of operations. COL holds 5 approved ANDAs for Injectable and Ophthalmic products while working on various projects in different completion stages for generic and specialty products across regulated and other markets.

Caplin Point Laboratories has delivered strong financial performance in the first half of FY26, demonstrating continued momentum in its global pharmaceutical operations. The company's strategic focus on emerging markets and regulated territories has translated into robust financial metrics and sustained profitability growth.

H1 FY26 Financial Performance

The company reported impressive growth across key financial parameters for H1 FY26. Revenue increased by 10.8% year-on-year, while profitability metrics exceeded sales growth rates significantly.

The company maintained strong return ratios with ROE at 20.00% and ROCE at 25.00%, reflecting efficient capital utilization and operational excellence.

Decade-Long Financial Transformation

Caplin Point Laboratories has demonstrated exceptional long-term growth, achieving significant scale expansion while maintaining profitability. The company's financial evolution from FY15 to FY25 showcases remarkable transformation across all key metrics.

The company has maintained a debt-free balance sheet throughout this growth period, with cash reserves growing from 100% of PAT in FY15 to over 200% of PAT in FY25.

Operational Excellence and Market Presence

Caplin Point Laboratories operates through a comprehensive distribution network spanning multiple geographies. The company's market presence includes significant touchpoints across Latin America and the United States, supporting its bottom-of-the-pyramid strategy.

The company's revenue contribution by geography as of Q2 FY26 shows LATAM accounting for 76%, US and regulated markets contributing 18%, and Africa representing 6% of total revenues.

Strategic Expansion and Product Development

Caplin Point Laboratories has been investing significantly in research and development, with R&D expenses reaching ₹89.00 crores in FY25, representing 4.6% of revenue. The company is developing over 90 in-house molecules and focusing on complex sterile manufacturing.

Key Development Areas:

• Complex injectables and ophthalmic formulations
• Specialized dual-chamber prefilled syringes
• Blow-Fill-Seal (BFS) technology for ophthalmics
• 10 ANDAs currently under review
• Recently acquired niche portfolio with $473 million addressable market

The company operates through its subsidiary Caplin Steriles Limited (CSL) and marketing arm Caplin Steriles USA Inc (CSU), which generated USD 3.2 million in revenue during its first eight months of operation.

Market Expansion and Geographic Diversification

Caplin Point Laboratories continues to expand its presence in regulated markets through strategic initiatives. In Mexico, the company has filed 35+ products with 20 approvals secured. The Chilean subsidiary holds 125+ product licenses and is gaining momentum in the private market.

The company has allocated a capital expenditure budget exceeding ₹1,000.00 crores, funded entirely through internal accruals, to triple capacities for high-demand product lines including Pre-Mixed Injectable Bags. This expansion supports the company's entry into Canada, Australia, and major Latin American economies including Brazil and Mexico.

Financial Efficiency and Return Metrics

Caplin Point Laboratories has maintained consistent return ratios over recent years, with ROE remaining in the 21-23% range since FY21 and ROCE performing between 26-29%. The company operates on a negative working capital model in LATAM markets through its selective credit strategy and owned distribution network, enabling faster cash cycles and tighter receivable control.