Wanbury Business Update
Wanbury Limited received nine "No DMF Deficiency" letters from the USFDA for Metformin HCl. The company also expanded its business in Saudi Arabia and Mexico with an annual revenue potential of Rs 25 Crore.
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Wanbury Limited received nine "No DMF Deficiency" letters from the USFDA for Metformin HCl. The company also expanded its business in Saudi Arabia and Mexico with an annual revenue potential of Rs 25 Crore.
Wanbury filed new Drug Master Files in South Africa, Philippines and Singapore for its APIs. It also added KSM vendors and received EDQM/TGA compliance clearances.
Wanbury Limited received a 'No DMF deficiency' letter from the USFDA for multiple ANDAs. This clearance facilitates expansion into the South Korean API market.
Wanbury Limited announced that the USFDA completed a cGMP inspection at its Tanuku facility, resulting in a Form 483 with six observations.
Wanbury Limited's Tanuku site successfully completed Australia's TGA inspection. This regulatory milestone enables the company to export three additional APIs to the Australian market.
Wanbury Limited's Patalganga site successfully completed a Korea FDA (MFDS) regulatory inspection with zero observations. The inspection, conducted from April 7 to April 9, 2026, confirms cGMP compliance. This approval follows previous zero-observation inspections by the USFDA and Anvisa, reinforcing the company's manufacturing compliance standards.