Wanbury Limited has announced significant regulatory approvals, including Sertraline Form II clearance from ANVISA Brazil and special grade Metformin DC approval from a major customer. The pharmaceutical company disclosed these developments through an official filing under Regulation 30 of SEBI listing requirements.

ANVISA Brazil Approves Sertraline Form II

The company has received approval from ANVISA Brazil for Sertraline Form II, adding to its existing Sertraline hydrochloride Form I approval. This regulatory milestone strengthens Wanbury's position in the Brazilian pharmaceutical market:

According to the company's regulatory filing, the Form II approval will help in further consolidation of Wanbury's share of business in the Brazilian market, where it already maintains a dominant position.

Special Grade Metformin DC Approval

Wanbury has secured approval from one of its largest customers for special grade Metformin DC, representing a significant revenue opportunity:

Manufacturing Compliance Maintained

The company confirmed that both its API manufacturing sites at Patalganga and Tanuku continue to remain compliant with cGMP Rules and Regulations. This compliance status supports the company's ability to manufacture and supply the newly approved products while maintaining regulatory standards across its operations.

Strategic Business Impact

These dual approvals represent important regulatory milestones for Wanbury's pharmaceutical business. The Sertraline Form II approval from ANVISA Brazil leverages the company's existing market leadership position, while the special grade Metformin DC approval opens a new revenue stream with substantial annual potential. The combination strengthens Wanbury's product portfolio and market presence in key therapeutic segments.

Wanbury Limited has delivered exceptional financial performance in Q3FY26 with net profit surging significantly compared to the previous year. The pharmaceutical company demonstrated remarkable operational efficiency and profitability improvement across key financial metrics, driven by higher API volumes and improved capacity utilization.

Outstanding Profitability Growth

The company achieved remarkable profitability improvement with profit after tax reaching ₹15.8 crores in Q3FY26 compared to ₹1.2 crores in Q3FY25, representing an impressive growth of 1194.3%. This exceptional performance reflects strong operating performance, margin expansion, improved cost efficiencies and lower finance costs.

Revenue Performance and Growth

Revenue from operations showed strong growth momentum reaching ₹162.4 crores in Q3FY26 compared to ₹133.5 crores in Q3FY25, marking a year-on-year growth of 21.7%. This revenue expansion was driven by higher API volumes, improved capacity utilization at key manufacturing facilities and steady performance in the formulations business.

EBITDA Performance and Margin Expansion

The company demonstrated remarkable operational efficiency with EBITDA reaching ₹26.9 crores in Q3FY26 compared to ₹14.8 crores in Q3FY25, representing strong growth of 81.7%. The EBITDA margin expanded significantly to 16.5% from 11.0% year-on-year, led by operating leverage, better procurement strategies, higher product yields and enhanced solvent recovery systems.

Nine-Month Performance Momentum

For the nine months ended December 31, 2025, Wanbury maintained strong momentum with profit after tax of ₹44.4 crores compared to ₹10.3 crores in the corresponding period, marking a substantial increase of 332.5%. Revenue from operations for the nine-month period stood at ₹485.7 crores versus ₹427.5 crores in the previous year, reflecting growth of 13.6%.

Business Highlights and Strategic Developments

According to Mr. Mohan Rayana, Director of Wanbury Ltd., the company achieved commercial invoicing and shipment to European customers for high potent anaesthetic API from its cutting-edge Tanaku facility in Q3FY26. The company is well positioned for growth with upcoming new product launches including Antidiabetic, Anticoagulant, Cough suppressant and Antidepressant products. The formulations business remained EBITDA positive with good results from the recent launch of nutritional supplement C-Red and other products.

Manufacturing Infrastructure and Capabilities

The company operates two USFDA approved API facilities with 386 KL cumulative reactor capacity and has achieved highest-ever operational EBITDA of ₹80 crore. The API business maintains 80%+ export top line with emphasis on developed markets including EU, Brazil and US. The formulations business is rebuilding legacy brand formulations in India with 10+ active brands across key therapeutic categories such as Anti cold & cough, Anti-infective, Anti-inflammatory, Supplements and Orthopaedic segments.