Wanbury gets nine USFDA DMF clearance letters for Metformin, adds Saudi Arabia and Mexico business

Wanbury Limited has received nine ‘No DMF Deficiency’ letters from the US Food and Drug Administration for its Metformin HCl Drug Master File during July and August 2026, strengthening its ability to supply the diabetes API to customers serving the regulated US generics market.

The letters were issued during the USFDA’s review of Abbreviated New Drug Applications filed by Wanbury’s customers. A Drug Master File provides confidential information on an API’s manufacturing, processing and quality controls to regulators. While the letters do not amount to product approvals, they indicate that the USFDA identified no deficiency in the DMF during the related customer reviews.

Wanbury said it also received No DMF Deficiency letters for Paroxetine and Diphenhydramine HCl over the same period. The outcome could help the company pursue further business with generic drug customers in the US, where regulatory compliance and product documentation are important entry requirements.

The development comes alongside fresh Metformin business in two overseas markets. Wanbury has commercialised a directly compressible Metformin product in Saudi Arabia, with estimated annual revenue potential of about Rs 10 crore. Separately, a customer in Mexico has won a two-year tender to supply Metformin, valued at approximately Rs 15 crore annually.

Together, the Saudi Arabian and Mexican opportunities carry indicated annual revenue potential of around Rs 25 crore. This is equivalent to roughly 3.8 per cent of Wanbury’s FY2025-26 revenue from operations of Rs 650.27 crore, although the eventual revenue contribution will depend on commercial ramp-up, customer offtake and tender execution.

Metformin remains a central product in Wanbury’s API portfolio. The company had earlier disclosed approval for a special grade of Metformin DC during FY2025-26. Its API business exports to more than 50 countries, with management stating that a majority of export revenue comes from regulated markets. The latest USFDA correspondence and overseas commercial wins therefore support its stated strategy of expanding through new molecules, regulated-market access and product-specific registrations.

Wanbury is also widening its API pipeline. It has completed validation for Quetiapine Fumarate, Sitagliptin and Empagliflozin, and plans regulatory filings for these products in the next quarter. The company expects the APIs to become available for sale in semi-regulated markets. Commercialisation will remain subject to completion of filings, customer qualification and market demand.

The company reported a stronger financial performance in FY2025-26, with revenue rising 8.5 per cent from Rs 599.51 crore in the preceding year. Profit after Tax more than doubled to Rs 66.13 crore from Rs 30.53 crore, supported by higher sales and lower finance costs. However, working-capital management remains relevant as trade receivables rose to Rs 143.28 crore on March 31, 2026, while receivables turnover declined during the year.

As of 2.37 pm on October 16, 2026, Wanbury shares were trading at Rs 192.80, up 3.35 per cent from the previous close of Rs 186.55. The stock was about 44 per cent below its 52-week high of Rs 344.25, though around 8.8 per cent above its 52-week low of Rs 177.20. Over one year, the shares have declined 26.56 per cent, compared with a 5.17 per cent fall in the BSE 500.

The next key milestone will be the planned filings for the three validated APIs and the pace at which the Saudi Arabian and Mexican Metformin opportunities translate into recurring sales.

Disclaimer: The article is for informational purposes only and not investment advice.