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 acquired 10 approved Abbreviated New Drug Applications (ANDAs) for injectable and ophthalmic products from a leading multinational generic drug manufacturer, strengthening its presence in regulated markets, particularly the US. The company announced the strategic acquisition through an exchange filing on January 01.

Acquisition Structure and Portfolio Details

The acquisition was executed through the company's subsidiaries Caplin Steriles Ltd. (CSL) and Caplin One Labs Ltd. (COL), with the acquired portfolio targeting an addressable market of $473.20 million for the 12-month period ended August 2025.

Strategic Market Expansion

Caplin Point Chairman CC Paarthipan emphasized the strategic importance of the acquisition, stating that "The US market remains a key growth engine for the Company, and this acquisition meaningfully accelerates our strategy by expanding and strengthening our portfolio in the region."

The acquired portfolio includes select oncology injectables, which will be transferred to and commercialized from the company's new dedicated oncology facility in Kakkalur. The company plans expansion to key non-US markets, including Mexico, Canada, the European Union, and Brazil.

Subsidiary Operations and Pipeline

Caplin Steriles, focusing on sterile formulations, has filed 53 ANDAs in the US market, achieving 49 approvals so far, including acquired products. The subsidiary maintains a robust pipeline of over 55 injectable and ophthalmic products planned for filing over the next four years.

Caplin One Labs, operating the oncology unit at Kakkalur, has acquired five of the 10 ANDAs under the current transaction, strengthening the company's oncology capabilities.

Recent Financial Performance

The company reported strong financial results for the September quarter, demonstrating solid operational performance across key metrics.

Market Response

Shares of Caplin Point Laboratories initially surged following the announcement, reaching intraday highs of ₹1,871.00, but later traded 0.60% lower at ₹1,827.10. The stock has declined 27.00% over the last 12 months, reflecting broader market conditions in the pharmaceutical sector.