Regulatory Milestones and USFDA Approvals

During July–August 2026, Wanbury Limited received 9 "No DMF Deficiency" letters from the USFDA specifically 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.

Additionally, the company received "No DMF Deficiency" letters for two more APIs: Paroxetine and Diphenhydramine HCl during the same period. These outcomes validate the quality of Wanbury's regulatory filings and create new business opportunities with customers in the regulated US market.

API Pipeline Expansion

Wanbury is expanding its API portfolio by validating new products including:

  • Quetiapine Fumarate
  • Sitagliptin
  • Empagliflozin

Regulatory filings for these products are planned in the next quarter (Q3 FY2027). These APIs are expected to be available for sale in semi-regulated markets, creating additional growth avenues for the company.

New Business Opportunities

Saudi Arabia Market

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

Mexico Market

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.

These opportunities collectively strengthen Wanbury's position as a leading global supplier of Metformin.

Management Commentary

Mr. Mohan Rayana, Director of Wanbury Limited, commented: "The 'No DMF Deficiency' letters from the USFDA are a strong endorsement of our quality and regulatory capabilities. With new Metformin business in Saudi Arabia and Mexico, and new APIs such as Quetiapine Fumarate, Sitagliptin and Empagliflozin in our pipeline, we are well placed for sustained growth."

Company Background

Established in 1988, Wanbury Limited is listed on the National Stock Exchange of India Ltd (Code: WANBURY) and BSE Ltd (Code: 524212). The company has:

  • Strong presence in API global market and domestic branded formulations
  • API exports to over 50 countries
  • Pan-India formulation presence
  • USFDA & EUGMP approved facilities at Tanuku (Andhra Pradesh) and Patalganga (Maharashtra)
API Product Portfolio Includes:
  • Antidiabetic
  • Antidepressant
  • Pain management
  • Antihistamine
  • Anti-inflammatory
  • Various other products in pipeline

The company's clients include leading global generic players.

Formulation Presence:

Wide presence across major therapeutic categories including:

  • Cough and cold solutions
  • Gynecology
  • Orthopedics
  • Nutraceuticals
  • Gastrointestinal
  • Anti-inflammatory
  • Analgesics

Forward-Looking Statements Disclaimer

The document contains forward-looking statements that reflect management's current views and estimates. Future results may differ due to risks including general economic conditions, foreign exchange fluctuation, pricing pressures, competition and regulatory developments.