Wanbury Receives USFDA Clearance for Metformin API; Strengthens Global Regulatory Position

Wanbury Limited has achieved a significant regulatory milestone after receiving a No Drug Master File (DMF) Deficiency Letter from the United States Food and Drug Administration (USFDA) for multiple Abbreviated New Drug Applications (ANDAs) that use the company’s Metformin Hydrochloride (HCl) Active Pharmaceutical Ingredient (API).

The development marks an important regulatory achievement for Wanbury and reinforces its commitment to maintaining global quality standards for pharmaceutical manufacturing.

Key Regulatory Highlights

The USFDA has confirmed that no deficiencies were identified in Wanbury’s DMF related to the Metformin HCl API used in several ANDA filings.

The approval covers:

• Metformin HCl API, a widely used active pharmaceutical ingredient for the treatment of Type 2 diabetes.
• Multiple ANDA applications submitted by formulation partners using Wanbury’s API for the US generic drug market.
• A clean regulatory status that enhances confidence among global pharmaceutical customers and partners.

This milestone removes an important regulatory hurdle for formulation companies relying on Wanbury’s Metformin API for their US market product approvals.

Strengthening Presence in the US Generic Market

Metformin HCl is one of Wanbury’s key API products and remains among the most widely prescribed diabetes medications globally. Receiving a No DMF Deficiency Letter from the USFDA strengthens the company’s credibility as a reliable API supplier for pharmaceutical companies targeting the highly regulated US generic drug market.

The regulatory clearance is expected to support existing customer relationships and improve opportunities for future API supply agreements in the United States.

Expansion into South Korea

In addition to strengthening its US regulatory position, Wanbury is also expanding its international presence in South Korea. The company has recently filed a Drug Master File (DMF) for another active pharmaceutical ingredient in the South Korean market, reflecting its continued focus on international market expansion and regulatory compliance.

This move is part of Wanbury’s broader strategy to diversify its global customer base and increase its presence across regulated pharmaceutical markets.