Indoco Remedies has achieved a significant regulatory milestone by securing final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution, 10 mg/mL. The approval was announced through a regulatory filing under Regulation 30 of SEBI Listing Regulations, marking an important step forward for the pharmaceutical company in expanding its presence in the competitive US market.

Product Specifications and Regulatory Details

The USFDA has granted final approval for Indoco Remedies' Brivaracetam Oral Solution, 10 mg/mL, which serves as a generic equivalent to the reference listed drug (RLD), Briviact 10 mg/mL, manufactured by UCB, Inc. The approved product has been determined to be bioequivalent and therapeutically equivalent to the reference drug, ensuring comparable safety and efficacy profiles.

Therapeutic Applications

Brivaracetam Oral Solution is a prescription antiepileptic drug (anticonvulsant) specifically indicated for the treatment of partial-onset seizures in patients 1 month of age and older. This approval enables Indoco Remedies to commercially market and distribute the medication in the United States, strengthening the company's position in the American pharmaceutical market and demonstrating its capability to meet stringent regulatory standards.

Management Commentary

Commenting on the achievement, Ms. Aditi Panandikar, Managing Director, stated, "The ANDA approval for Brivaracetam is a significant milestone for us as we continue to strengthen our presence in the Regulated Markets. We are committed to offering innovative and affordable healthcare to patients worldwide." The approval represents a key addition to the company's portfolio of USFDA-approved pharmaceutical products and reinforces its commitment to expanding access to essential medications.

Manufacturing and Company Profile

The Brivaracetam Oral Solution will be manufactured at Indoco Remedies' facility located in Verna Industrial Area, Goa. The company operates as a fully integrated, research-oriented pharmaceutical organization with a global turnover of USD 180 million and employs over 6,000 people, including more than 400 skilled scientists. Indoco maintains 10 manufacturing facilities and has received approvals from major regulatory authorities including USFDA and UK-MHRA.

Indoco Remedies Limited held its Q3 FY26 earnings conference call on February 03, 2026, presenting a mixed performance with strong international growth offsetting domestic challenges. The pharmaceutical company demonstrated resilience in its export divisions and API business while navigating headwinds in the domestic acute therapy segment.

Financial Performance Overview

The company's financial metrics for Q3 FY26 reflected both growth opportunities and operational challenges across different business segments.

The company showed significant improvement in profitability metrics, with consolidated EBITDA margin expanding from 3.0% to 7.3% year-on-year. Managing Director Aditi Panandikar noted that the quarter delivered better performance, particularly in exports divisions and API business, along with improved contributions from subsidiaries.

Business Segment Analysis

Domestic Formulation Challenges

Domestic formulation revenues declined to INR2,142 million from INR2,241 million in the same quarter last year. The company faced headwinds in acute therapies, though management emphasized that secondary sales and prescription response remained intact. Despite the challenges, Indoco achieved a significant milestone by jumping one rank in IQVIA prescription audit to 21st position with 10.86 crores prescriptions, surpassing Pfizer.

Major therapeutic segments including vitamins, anti-diabetes, anti-infectives, and respiratory showed positive performance during the quarter. The company's new product introductions now contribute 6.5% of India revenues, indicating successful portfolio expansion efforts.

International Business Momentum

The international formulation business emerged as a key growth driver with impressive performance across multiple markets.

The strong international performance was driven by improved product portfolio quality and better market penetration. Management expressed particular satisfaction with emerging markets growth, noting improvements in both primary sales and secondary market performance.

API Business and Manufacturing Updates

The API business demonstrated robust growth with revenues increasing 24% to INR344 million compared to INR278 million in the same quarter last year. The Patalganga API site received EIR (Establishment Inspection Report) for USFDA audit with zero 483 observations, marking a significant regulatory achievement.

Management highlighted that the API business benefits from both external sales and internal consumption, with approximately 40% of API production supplied internally to support formulation manufacturing. The company expects further capacity expansion from the Auric site validation activities to drive future growth.

Subsidiary Performance and Strategic Initiatives

Warren Remedies Growth

Warren Remedies showed exceptional performance with over 43% growth during the quarter, driven by success in OTC and OTX segments. The subsidiary launched two new products in Q3 FY26:

• Sensodent DSP: Daily sensitivity protection toothpaste
• Sensodent DPC: Daily care toothpaste for premium segment entry

These launches represent strategic brand extensions and market segment expansion initiatives in the oral care business.

FPP US Operations

The US subsidiary FPP demonstrated improved profitability after initial challenges since its acquisition in June 2023. The company has successfully expanded the product portfolio beyond initial traded products to include solid oral formulations supplied from Indoco's manufacturing sites. Management expects five new product launches from FPP's portfolio in FY27, including recently approved lacosamide oral suspension.

Operational Challenges and Remediation Costs

The company incurred approximately INR8-9 crores in one-time costs during the quarter, including remediation expenses and penalties related to supply constraints from regulatory issues. These non-recurring costs impacted quarterly performance but are expected to normalize as manufacturing capabilities are restored and alternative supply arrangements are established.

Management confirmed ongoing efforts to control other expenses at the consolidated level, targeting INR150 crores annually while managing validation and remediation activities.

Outlook and Strategic Focus

Looking ahead, Indoco Remedies is positioned for improved performance across multiple business segments. The company's strategy focuses on transitioning from acute to sub-chronic therapies, expanding from general practitioners to mass specialty doctors, and strengthening presence in metropolitan markets. International business growth momentum is expected to continue with new product approvals and improved manufacturing capabilities supporting market expansion.