StockWatch
·
Pharmaceuticals
USFDA16 Oct 2026, 01:13 pm

Wanbury Gets 9 USFDA 'No DMF Deficiency' Letters

AI Summary

Wanbury Limited announced significant progress in its API business. The company received 9 'No DMF Deficiency' letters from the USFDA for its Metformin HCl Drug Master File (DMF) during July-August 2026. Additionally, it received similar letters for Paroxetine and Diphenhydramine HCl, strengthening its position in the US market. Wanbury is expanding its API pipeline with new products like Quetiapine Fumarate, Sitagliptin, and Empagliflozin, planned for regulatory filings next quarter. The company is also growing its Metformin business, with new commercialization in Saudi Arabia (potential ₹10 crore annual revenue) and a two-year tender win in Mexico (valued at approximately ₹15 crore per annum). These developments underscore Wanbury's regulatory capabilities and growth prospects.

Key Highlights

  • Received 9 USFDA 'No DMF Deficiency' letters for Metformin HCl DMF.
  • Secured 'No DMF Deficiency' letters for Paroxetine and Diphenhydramine HCl.
  • Expanding API pipeline with Quetiapine Fumarate, Sitagliptin, Empagliflozin.
  • New Metformin business in Saudi Arabia with ₹10 crore annual revenue potential.
  • Won ₹15 crore per annum Metformin tender in Mexico.