Wanbury expands global API reach with DMF filings and clean Korea FDA audit
Wanbury Limited expanded its global API reach by submitting Drug Master Files for Diphenhydramine HCl in Malaysia and Singapore, and planning submissions for Paroxetine HCl in Korea and Latin America. The company's Patalganga facility secured a zero-observation audit report from the Ministry of Food and Drug Safety, Korea FDA, following an inspection in April 2026.

*this image is generated using AI for illustrative purposes only.
Wanbury Limited announced on June 9, 2026, that it has expanded its regulatory submissions for new Active Pharmaceutical Ingredients (APIs) to strengthen its presence in global markets. The company submitted Drug Master Files (DMFs) for Diphenhydramine HCl to Malaysia and Singapore. Additionally, Wanbury proposed to explore new market opportunities for Paroxetine HCl in Korea and Latin America by submitting DMFs in these regions.
Regulatory Approvals and Facility Audit
The company received a formal audit report from the Ministry of Food and Drug Safety (MFDS), Korea FDA, for its Patalganga facility. The report stated zero observations for the inspection conducted in April 2026. This follows the company's earlier financial disclosure for the year ended 31 March 2026, where it reported a 116.6% surge in net profit to ₹66.1 crore, driven by operational efficiency and new product launches.
Financial Performance Summary
Wanbury's audited financial results for FY26 showed revenue from operations rising to ₹650.3 crore from ₹599.5 crore in the previous year. EBITDA grew 34.9% to ₹107.7 crore. The board approved these results at its meeting on May 29, 2026.
| Metric: | FY26 | FY25 | Q4 FY26 | Q4 FY25 |
|---|---|---|---|---|
| Net Profit: | ₹66.1 crore | ₹30.5 crore | ₹21.7 crore | ₹20.3 crore |
| Revenue from Operations: | ₹650.3 crore | ₹599.5 crore | ₹164.6 crore | ₹172.0 crore |
| EBITDA*: | ₹107.7 crore | ₹79.8 crore | ₹30.1 crore | ₹31.5 crore |
| EPS: | ₹20.55 | ₹9.32 | - | - |
*Includes Other Income
Historical Stock Returns for Wanbury
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -1.70% | +2.39% | -3.21% | +14.94% | -1.53% | +182.84% |
What is the expected timeline for regulatory approval of the DMFs submitted to Malaysia, Singapore, Korea, and Latin America?
How will the zero observations from the Korea FDA audit impact Wanbury's ability to secure new partnerships in the Asian market?
What are the projected revenue contributions from the new Diphenhydramine HCl and Paroxetine HCl markets over the next fiscal year?

































