Wanbury Limited has secured nine “No DMF Deficiency” letters from the US Food and Drug Administration (USFDA) for its Metformin Hydrochloride (HCl) Drug Master File (DMF).
The development comes as it expands its Metformin business in Saudi Arabia and Mexico, strengthening its regulatory standing and growth prospects in key international markets.
The regulatory milestones, achieved during July–August 2026, came as the USFDA reviewed Abbreviated New Drug Applications (ANDAs) filed by Wanbury’s customers.
The company also received “No DMF Deficiency” letters for two additional active pharmaceutical ingredients (APIs) — Paroxetine and Diphenhydramine HCl — opening up further opportunities in the tightly regulated US market.
Wanbury is widening its API portfolio, with validation underway for Quetiapine Fumarate, Sitagliptin and Empagliflozin. Regulatory filings for the three products are planned for the next quarter, with commercial availability targeted in semi-regulated markets.
The planned additions are expected to broaden the company’s product portfolio and create new avenues for growth.
Wanbury has commercialised a new Metformin direct-compression (DC) business in Saudi Arabia, with the opportunity carrying an estimated annual revenue potential of around Rs 10 crore.
In Mexico, a customer of the company has secured a two-year tender to supply Metformin, valued at approximately Rs 15 crore annually.
Together, the two opportunities represent a potential annual business value of around Rs 25 crore, based on the stated estimates, and reinforce Wanbury’s push to expand its global Metformin franchise.
With regulatory clearances advancing, new APIs moving through validation and fresh business opportunities emerging in international markets, Wanbury is positioning its pharmaceutical ingredients business for further growth.
