Wanbury Receives USFDA No DMF Deficiency Letter

Regulatory Compliance Update

Wanbury Limited has received a "No DMF deficiency letter" from the office of USFDA (US Food and Drug Administration) for multiple ANDAs (Abbreviated New Drug Applications). These applications utilize Wanbury's Metformin HCl API as the source for different formulations.

This notification confirms that the company's Drug Master Files (DMFs) have been found fully compliant with USFDA requirements, indicating no deficiencies in the documentation or quality standards for the referenced ANDAs.

Business Expansion Context

The disclosure references previous information about Wanbury's expansion of business opportunities in South Korea, where the company filed another DMF for one more API to enter this new market.

Strategic Commitment

The company states its commitment to supplying the best APIs to new markets for the well-being of human beings, positioning this regulatory compliance as part of its quality assurance and market expansion strategy.

Disclosure Basis

This information is being disclosed pursuant to Regulation 30 of SEBI LODR (Listing Obligations and Disclosure Requirements), indicating this is a material event requiring stock exchange notification.