Bajaj Healthcare has received regulatory approval from the Drug Controller General of India (DCGI) under the Central Drugs Standard Control Organization (CDSCO) to manufacture and market Cenobamate API and tablets. The approval covers six strengths: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.

This regulatory clearance makes Bajaj Healthcare the first company in India to launch Cenobamate, a next-generation antiseizure medication indicated for treating partial-onset seizures in adults. The approval follows a recommendation from the Subject Expert Committee (SEC) for Neurology & Psychiatry, which the company previously communicated on June 26, 2026.

Strategic Significance

Cenobamate addresses a critical need in epilepsy care, with clinical studies demonstrating significant seizure reduction and high seizure-freedom rates in patients with inadequately controlled epilepsy. The launch strengthens Bajaj Healthcare’s presence in the Central Nervous System (CNS) segment.

Anil Jain, Managing Director of Bajaj Healthcare, stated that the approval reflects the company’s commitment to developing differentiated, complex, and high-value pharmaceutical products. He noted that the milestone demonstrates the strength of the company’s integrated API and formulation capabilities.

Product Portfolio Expansion

The company plans to take the product to market immediately, aiming to build Cenobamate as a key addition to its pharmaceutical portfolio. Management believes this launch will strengthen its CNS franchise and create opportunities for sustainable long-term growth.

Bajaj Healthcare operates state-of-the-art manufacturing facilities designed to meet requirements for both regulated and emerging markets. The company serves customers across Europe, the USA, Australia, the Middle East, and South America.

Bajaj Healthcare Limited reported a net profit of ₹13.7 crore for the quarter ended June 30, 2026, an increase of 15.8% compared to the same period last year, driven by robust domestic API sales and expanding margins. During its first-ever earnings call on July 21, 2026, management provided forward-looking guidance, projecting revenue growth of 10% to 15% for FY27, supported by stable API prices and volume-led expansion in the domestic segment.

The company’s revenue from operations grew 11.3% year-on-year to ₹165.63 crore, while EBITDA margins expanded to 17.8% from 17.0% in Q1FY26. Managing Director Anil Jain highlighted that domestic API sales rose 27.1% year-on-year to ₹92.26 crore, offsetting a decline in export sales due to geopolitical disruptions in West Asia. The improved financial performance was further bolstered by a sequential revenue growth of 8.2% from ₹153.06 crore in the preceding quarter.

Financial Performance

Profit after tax (PAT) margin improved to 8.3% from 8.0% in the prior year. Gross profit increased 16.2% to ₹80.4 crore, with gross margins expanding to 48.3% from 46.2% in Q1FY26. Chief Financial Officer Rohan Parekh noted that net worth stood at ₹533 crore as of March 31, 2026, up from ₹466 crore last year, with the debt-to-equity ratio improving to 0.45 from 0.48 in FY25.

Strategic Initiatives and Pipeline

Bajaj Healthcare secured a recommendation from the US Securities and Exchange Commission (SEC) for Cenobamate Tablets, a milestone for commercializing this anti-seizure medication. The company expects to generate ₹10–12 crore in revenue from this product in FY27. Additionally, Bajaj Oncocare, launched in 2024, now operates across 23 states with over 15 brands. The company is also advancing its peptide manufacturing facility, targeting commissioning by Q4 2027, with initial production focused on Semaglutide for the Indian market.

What the Numbers Show

The divergence between domestic API growth (27.1%) and export declines highlights a strategic shift towards high-margin domestic markets and specialty formulations. With receivable days improving from 145 to 131 days, management anticipates further working capital optimization. The planned capex of ₹40–50 crore annually will fund backward integration in Vitamin C and other key molecules, aiming to reduce dependency on Chinese raw materials and enhance long-term margins.

Regulatory Disclosure

In an intimation under Regulation 30 of SEBI (LODR) Regulations, 2015, the company confirmed that the transcript of the earnings call held on July 21, 2026, has been uploaded to its website. The company filed two CEP applications during the quarter, bringing cumulative filings to twelve, with eight approved and four under review.

Source: https://lodr-files.dhan.co/lodr-inputs/Company/INE411U01027/9aebc345-6dab-4c87-a71c-8b7e6878bd38.pdf