BSECompany Update4d ago · 16 Oct 2026, 01:12 pm

Wanbury Limited - Regulatory Progress in API Business, New Business Opportunities and Operational Achievements

Wanbury Ltd · 524212

✦ AI Summary▲ PositiveResults

Wanbury Ltd has received 9 'No DMF Deficiency' letters from USFDA for Metformin HCl, expanding its Metformin business in Saudi Arabia and Mexico, and validating new APIs such as Quetiapine Fumarate, Sitagliptin, and Empagliflozin. The company has also commercialized a new Metformin DC business in Saudi Arabia with an annual revenue potential of about Rs 10 crore and won a two-year tender for the supply of Metformin in Mexico valued at approximately Rs 15 crore per annum.

Analysis Scores

Earnings Impact8/10
Growth Catalyst9/10
Governance Concern1/10
Regulatory Risk2/10
Balance Sheet Risk1/10
Liquidity Impact9/10
Market Sentiment9/10

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Wanbury Ltd - 524212 - Announcement under Regulation 30 (LODR)-Press Release / Media Release

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Wanbury Limited Regd. Office: BSEL Tech Park, B- Wing, 10th Floor, Sector-30A, Opp. Vashi Railway Station, Vashi, Navi Mumbai 400703 Maharashtra, INDIA Tel: +91-22-6794 2222 +91-22-7196 3222 CIN: L51900MH1988PLC048455 Email: info@wanbury.com Website: www.wanbury.com October 16, 2026 BSE Limited National Stock Exchange of India Ltd, PJ. Towers, Exchange Plaza, Dalal Street Bandra Kurla Complex, Mumbai – 400 001. Bandra (East), Mumbai -400 051. Script Code: 524212 Script Code: WANBURY Dear Sir/Madam, Sub.: Wanbury Limited – Regulatory Progress in API Business, New Business Opportunities and Operational Achievements Pursuant to Regulation 30 of SEBI LODR, we wish to inform you as under: Please find enclosed the press release highlighting the Company's regulatory progress in its API business, expansion of its product pipeline and new business opportunities in Saudi Arabia and Mexico. This is for your information and records. Thanking you. Yours faithfully, For Wanbury Limited Jitendra J. Gandhi Company Secretary Encl.: a/a US Europe Brazil Korea India Mexico Canada China WHO GMP PRESS RELEASE Key Updates and Developments Wanbury Receives 9 “No DMF Deficiency” Letters from USFDA for Metformin HCl, Expands Metformin Business in Saudi Arabia and Mexico Mumbai, 16th Oct 2026: Wanbury Limited today shared key updates across regulatory approvals, its API pipeline, new Metformin business and recognition for its manufacturing sites. Regulatory milestones: “No DMF Deficiency” letters from USFDA During July–August 2026, Wanbury 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) filed by Wanbury’s customers. In the same period, the company also received “No DMF Deficiency” letters for two more APIs: Paroxetine and Diphenhydramine HCl. These outcomes reaffirm the quality of Wanbury’s regulatory filings 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 filings for these products are planned in next quarter. The APIs are expected to be available for sale in semi-regulated markets, adding to the company’s growth avenues. Business growth: Saudi Arabia and Mexico  Saudi Arabia: Wanbury has commercialised a new Metformin DC (directly compressible) business in Saudi Arabia, 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. The tender is valued at approximately Rs 15 crore per annum. Together, these opportunities strengthen Wanbury’s position as a leading global supplier of Metformin. US Europe Brazil Korea India Mexico Canada China WHO GMP Commenting on the developments, Mr. Mohan Rayana, Director of Wanbury Limited said, “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”. About Wanbury Ltd: Established in 1988, listed on the National Stock Exchange of India Ltd (Code: WANBURY) and BSE Ltd (Code: 524212). The company has a strong presence in API global market and domestic branded Formulation with its API being exported to over 50 countries and has Pan-India Formulation presence. The company has USFDA & EUGMP approved facilities at Tanuku (Andhra Pradesh) and Patalganga (Maharashtra). The API product portfolio includes Antidiabetic, Antidepressant, Pain management, Antihistamine, Anti-inflammatory, Antidepressant and various other products in pipeline. The company's clients include some of the leading global generic players. In formulations, the company has a wide presence across major therapeutic categories like cough and cold solutions, gynecology, orthopedics, nutraceuticals, gastrointestinal, anti-inflammatory, & analgesics. For more details on Wanbury Ltd.: https://www.wanbury.com/ For any Investor Relations query, please contact: Jitendra J. Gandhi Smit Shah / Hanishi Shah Company Secretary, Adfactors PR Wanbury Limited Oasis Complex, Kamala Mills Compound, BSEL Techpark,B' Wing, 10th Floor, City Hall, Pandurang Budhkar Marg, Sector 30-A,Opp. Vashi Railway Station, Lower Parel West, Mumbai – 400021 Vashi, Navi Mumbai - 400703, Tel : +91 9870789596 / +91 9619059339 Maharashtra, India. Email : smit.shah@adfactorspr.com / Tel: +91-22-6794 2222 hanishi.shah@adfactorspr.com Email: jitendra.gandhi@wanbury.com Caution Concerning Forward- Looking Statements: This document may contain statements, which reflect management’s current views and estimates and could be construed as forward-looking statements. The future involves certain risks and uncertainties and could cause actual results to differ materially from the current views being expressed. Potential risks and uncertainties include factors such as general economic conditions, foreign exchange fluctuation, pricing pressures, competition and regulatory developments. US Europe Brazil Korea India Mexico Canada China WHO GMP