India, July 30 -- Wanbury Ltd. has received a "No DMF Deficiency" letter from the US Food and Drug Administration (USFDA) for multiple Abbreviated New Drug Applications (ANDAs) that use the company's Metformin HCl API across different formulations.
The regulatory milestone strengthens Wanbury's position as a reliable API supplier for the US market and supports approvals linked to these ANDAs.
The company also announced that it has expanded its presence in South Korea by filing a Drug Master File (DMF) for another active pharmaceutical ingredient (API), reaffirming its commitment to supplying high-quality APIs to new international markets.
Published by HT Digital Content Services with permission from Dion Global Solutions Limited....