Wanbury524212Regulatory approval

Wanbury gets 9 USFDA 'No DMF Deficiency' letters for Metformin HCl; new business in Saudi Arabia and Mexico

Wanbury received 9 "No DMF Deficiency" letters from USFDA for Metformin HCl DMF (July–August 2026), plus such letters for 2 more APIs: Paroxetine and Diphenhydramine HCl.

By ScoutQuest · Fri 16 Oct 2026, 1:13 PM IST · 2 min read

USFDA No DMF Deficiency letters: 9 letters for Metformin HCl DMF (July–August 2026); also for Paroxetine and Diphenhydramine HCl
Saudi Arabia revenue potential: New Metformin DC business, about Rs 10 crore annual revenue potential
Mexico tender value: Two-year Metformin tender, about Rs 15 crore per annum

What the company announced

Wanbury Limited informed the exchanges about regulatory progress in its API (active pharmaceutical ingredient) business, an expanded product pipeline and new business opportunities in Saudi Arabia and Mexico, shared through a press release.

USFDA "No DMF Deficiency" letters

During July-August 2026, the company received 9 "No DMF Deficiency" letters from the USFDA 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) shared by Wanbury's customers.

In the same period, the company also received "No DMF Deficiency" letters for two more APIs: Paroxetine and Diphenhydramine HCl.
A Drug Master File is the document a manufacturer files with a regulator describing how a drug ingredient is made and controlled. A "No DMF Deficiency" letter means the regulator did not raise a deficiency on that file.
The company says these outcomes reaffirm the quality of its regulatory updates and open up new business opportunities with customers in the regulated US market.

Strengthening the API pipeline

Wanbury is expanding its API portfolio by validating new products, including Quetiapine Fumarate, Sitagliptin and Empagliflozin. Regulatory updates for these products are planned in the next quarter. The APIs are expected to be available for sale in semi-regulated markets.

New business in Saudi Arabia and Mexico

Saudi Arabia: the company has commercialised a new Metformin DC (directly compressible) business, with an annual revenue potential of about Rs 10 crore.
Mexico: Wanbury's customer in Mexico has won a two-year tender for the supply of Metformin, valued at approximately Rs 15 crore per annum.

The release states that together these opportunities strengthen Wanbury's position as a supplier of Metformin.

What management said

Mr. Mohan Rayana, Director of Wanbury Limited, said the "No DMF Deficiency" letters from the USFDA are a strong endorsement of the company's quality and regulatory capabilities, and that with new Metformin business in Saudi Arabia and Mexico and new APIs such as Quetiapine Fumarate, Sitagliptin and Empagliflozin in the pipeline, the company is "well placed for sustained growth".

How to read the numbers

The Saudi Arabia figure is described as annual revenue potential, and the Mexico figure as a tender valued at approximately Rs 15 crore per annum over two years. Both are stated as potential and tender value in the release. The release also carries a caution that it may contain forward-looking statements, and that actual results could differ materially due to factors such as general economic conditions, foreign exchange fluctuation, pricing pressures, competition and regulatory developments.

About the company

Established in 1988, Wanbury is listed on the NSE (Code: WANBURY) and BSE (Code: 524212). Its API business exports to over 50 countries, and it has a Pan-India formulation presence, with USFDA and EUGMP approved facilities at Tanuku (Andhra Pradesh) and Patalganga (Maharashtra).

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