ALFA Finder| Market Cap | ₹715.11 CrPharmaceuticals |
|---|---|
| P/E TTM | 13.6Sector PE: 43.82 |
| Revenue TTM | ₹675.52 CrOperating Income |
| Promoter Holding | 42.98%Latest Quarter |
Key highlights
- Received CADIFA (Letter of Suitability for API) from ANVISA for Metformin HCl EP grade
- Marks the third consecutive regulatory approval from Brazil's FDA for Wanbury's APIs
- Approval enables Brazilian pharmaceutical companies to use Wanbury APIs in formulations
- Company has initiated commercial talks with customers to increase business volumes in Brazil
- Follows recent Australian TGA and USFDA clearances for the same product line in late 2026
Brazil Market Access via ANVISA CADIFA Approval
Wanbury Limited has secured a CADIFA (Letter of Suitability for API) from Brazil's National Health Surveillance Agency, ANVISA, for its flagship product, Metformin HCl EP grade. This regulatory milestone serves as a critical entry point for the Brazilian pharmaceutical market, as it enables local manufacturers to incorporate Wanbury active ingredients into their finished drug formulations. The approval is the third consecutive clearance the company has received from ANVISA, reflecting a consistent regulatory track record in the South American region.
Following the notification, the management confirmed that they have already commenced negotiations with various customers to scale supply volumes in this geography.
Expanding Global Footprint for Metformin HCl API
The Metformin HCl portfolio has seen significant regulatory momentum throughout 2026. In October, Wanbury received Australian TGA GMP compliance for its Tanuku plant, covering Metformin alongside five other APIs. Furthermore, the company recently secured nine USFDA No DMF Deficiency letters for the product and previously won a 15 crore annual tender in Mexico.
This Brazilian approval complements an existing commercial pipeline that includes a 10 crore per year supply agreement in Saudi Arabia. These clearances are part of a broader strategy to leverage the flagship API across regulated markets including North America, Europe, and now South America.
Recent Regulatory and Commercial Milestones
- October 2026: Australian TGA GMP Compliance Certificate for the Tanuku plant covering six APIs
- October 2026: Confirmed 25 crore annual commercial pipeline via Saudi Arabia and Mexico deals
- August 2026: EDQM approval (CEP) for Rivaroxaban API and USFDA DMF clearances for Metformin
- June 2026: South Korea MFDS GMP certification for the Patalganga manufacturing facility
- March 2026: ANVISA approval for Sertraline Form II API and special grade Metformin DC
Financial Performance and Sector Context
For the quarter ended September 30, 2026, Wanbury reported operating revenue of 182.91 crore, marking a 14.3 percent year-on-year growth. The net profit for the same period stood at 11.88 crore, representing a 266.4 percent sequential growth from the previous quarter. The company is currently trading at a P/E of 13.6x, significantly lower than the industry P/E of 42.2x.
Management has previously issued revenue guidance indicating that four new APIs from the Tanuku block are projected to deliver over 100 crore in revenues by FY27, supported by the ongoing cycle of international regulatory approvals.
| Date | Announcement | Amount |
|---|---|---|
| 30 Oct 2026 | Australian TGA GMP Compliance Certificate for Tanuku plant covering six APIs (Metformin HCl, Tramadol HCl, Sertraline HCl, Diphenhydramine HCl, Mefenamic Acid, Paroxetine HCl Hemihydrate)Source: indiaadvantage.co.in | – |
| 16 Oct 2026 | Nine USFDA No DMF Deficiency letters for Metformin HCl, USFDA clearances for Paroxetine and Diphenhydramine HCl, and Metformin business in Saudi Arabia and MexicoSource: c-sec.com | ₹25.00 Cr |
| 08 Oct 2026 | EDQM approval for Paroxetine HCl API with additional KSM vendors and Australian TGA compliance report acceptanceSource: stockplus.co.in | – |
| 13 Aug 2026 | EDQM approval for Rivaroxaban API (CEP) and USFDA DMF clearances for Paroxetine HCl and Metformin HClSource: BSE filing | – |
| 10 Jun 2026 | South Korea MFDS GMP certification for Patalganga plant and Australian TGA inspection clearance for Tanuku facilitySource: NSE filing | – |
| 12 Mar 2026 | ANVISA Brazil approval for Sertraline Form II API and customer approval for special grade Metformin DCSource: aliceblueonline.com | ₹15.00 Cr |
What to watch next
- Resumption of Ketamine HCl API dispatches scheduled for November 2026
- Target regulatory filings for Quetiapine Fumarate and Sitagliptin planned for Q3 FY27
- Execution of the 100 crore revenue guidance from new Tanuku block APIs by FY27
| Share price | ₹204.51 |
|---|---|
| Market capitalisation | ₹715.11 Cr |
| Revenue (annual) | ₹650.27 Cr |
| Net profit (annual) | ₹66.13 Cr |
| Revenue (latest quarter) | ₹182.91 Cr+10.46% vs previous quarter |
| Net profit (latest quarter) | ₹11.88 Cr+266.41% vs previous quarter |
| P/E (TTM) | 13.6×Sector 43.82× |
| Promoter holding | 42.98%-0.04% QoQ |
| FII holding | 0.71%Current quarter |
Reference market data from a third-party provider, as of the story. Not a valuation or a recommendation.
Exchange filing by Wanbury Limited announcing the receipt of ANVISA approval for its Metformin HCl API. Market figures from a third-party data provider.
