Wanbury shares updates on regulatory approvals for its API pipeline

During July?August 2026, Wanbury received 9 ?No DMF Deficiency? letters from the USFDA for its Metformin HCl Drug Master File (DMF). These letters were issued as part of the USFDA's review of Abbreviated New Drug Applications (ANDAs) filed by Wanbury's customers.

In the same period, the company also received ?No DMF Deficiency? letters for two more APIs: Paroxetine and Diphenhydramine HCl. These outcomes reaffirm the quality of Wanbury's regulatory filings and open up new business opportunities with customers in the regulated US market.

Wanbury is expanding its API portfolio by validating new products, including Quetiapine Fumarate, Sitagliptin and Empagliflozin. Regulatory filings for these products are planned in next quarter. The APIs are expected to be available for sale in semi-regulated markets, adding to the company's growth avenues.

Wanbury has commercialised a new Metformin DC (directly compressible) business in Saudi Arabia, with an annual revenue potential of about Rs 10 crore.

Wanbury's customer in Mexico has won a two-year tender for the supply of Metformin. The tender is valued at approximately Rs 15 crore per annum.

Together, these opportunities strengthen Wanbury's position as a leading global supplier of Metformin.