Wanbury has announced the expansion of its regulatory submission strategy for new Active Pharmaceutical Ingredients (APIs). The company has submitted Drug Master Files (DMFs) for Diphenhydramine HCl to both Malaysia and Singapore markets, with ₹22.50 crore estimated incremental export potential over 24 months from these filings. The company has also proposed to explore new market opportunities for Paroxetine HCl in Korea and Latin America by submitting corresponding DMFs, targeting the growing demand for antihistamines in Southeast Asia and strengthening its Central Nervous System (CNS) portfolio in Korean and Latin American markets.
The company received a significant regulatory milestone with formal audit approval from the Korea FDA (MFDS) for its Patalganga facility. The inspection was conducted in April 2026 and resulted in zero observations from the regulatory authorities. This approval provides Wanbury with enhanced market access capabilities in the Korean pharmaceutical market, with the clean audit specifically opening doors to the South Korean market known for stringent quality standards. The clean chit from KFDA is a major positive for Wanbury's Patalganga unit, reducing systemic regulatory risk and enhancing credibility for Asian markets.
Wanbury's financial results for FY26 demonstrate robust growth across key metrics. The company reported a 116.6% surge in net profit to ₹66.1 crore compared to ₹30.5 crore in FY25, driven by operational efficiency and new product launches. Revenue from operations increased to ₹650.3 crore from ₹599.5 crore in the previous year, while EBITDA grew 34.9% to ₹107.7 crore. The board approved these results at its meeting on May 29, 2026, with EPS improving to ₹20.55 from ₹9.32 in the previous fiscal year.
In March 2026, Wanbury reported 15% YoY growth in its API business, demonstrating strong operational performance. The board approved an investment of ₹45 crore in April 2026 for enhancing capacity at the Patalganga plant to meet rising European demand. In May 2026, the company successfully renewed its WHO-GMP certification, further solidifying its manufacturing credentials. The company is successfully navigating complex regulatory landscapes of developed markets and positioning for robust FY27 export performance through its dual success of facility compliance and portfolio expansion.
