| P/E TTM | 21.97Sector 45.1 |
|---|---|
| Market Cap | ₹15,231.67 CrMid-cap |
| Revenue TTM | ₹7,783.95 CrOperating |
| RSI | 33.18Near Oversold |
Key highlights
- USFDA grants final approval for Valganciclovir for Oral Solution, 50 mg/mL
- Product is therapeutically equivalent to Valcyte by CHEPLAPHARM Arzneimittel GmbH
- Approval targets cytomegalovirus (CMV) retinitis in AIDS patients and transplant recipients
- Company reaches a cumulative total of 247 USFDA ANDA approvals
- Quarterly revenue grew 25.66% YoY to ₹2,149.77 crore in June 2026
Expanding Generic Portfolio in US Market
Alembic Pharmaceuticals Limited has secured final USFDA approval for its Valganciclovir for Oral Solution, 50 mg/mL. This regulatory milestone allows the company to market a generic version of Valcyte, which is specifically indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Furthermore, the solution is utilized for the prevention of CMV disease in high-risk kidney, heart, and kidney-pancreas transplant patients.
The approval marks a significant addition to Alembic's injectable and oral solution portfolio, targeting high-need therapeutic areas in transplant medicine and infectious diseases.
Approval Trajectory and Pipeline Growth
- Cumulative total of 247 USFDA ANDA approvals achieved to date
- Total includes 227 final approvals and 20 tentative approvals
- Recent approval follows Ciprofloxacin and Dexamethasone Otic Suspension on October 17, 2026
- R&D expenditure guided at approximately 9% of revenue for FY27
- Management has upgraded FY27 revenue growth outlook to the mid-teens range
Financial Performance and Strategic Outlook
The approval comes as Alembic maintains a steady growth trajectory, reporting a 25.66% year-on-year increase in operating revenue for the quarter ended June 30, 2026. While the stock has seen a 16.19% decline over the past year, it is currently trading at a P/E ratio of 21.97, significantly lower than the industry average of 45.11. To support its expanding product pipeline, the company has guided for capital expenditure between ₹300 crore and ₹350 crore for FY27.
With promoter holdings stable at 69.87%, the company continues to leverage its vertically integrated research and development capabilities to drive generic launches in global markets.
| Date | Announcement | Amount |
|---|---|---|
| 17 Oct 2026 | USFDA final approval for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%Source: sahi.com | – |
| 16 Sep 2026 | USFDA Establishment Inspection Report (EIR) issued closing inspection of Vadodara Bioequivalence FacilitySource: NSE filing | – |
| 28 Jul 2026 | USFDA final approval for Prucalopride Tablets, 1 mg and 2 mgSource: alembicpharmaceuticals.com | – |
| 18 Jul 2026 | USFDA tentative approval received by partner NATCO Pharma for Olaparib Tablets (100 mg and 150 mg) for US distribution by AlembicSource: alembicpharmaceuticals.com | – |
| 26 Jun 2026 | USFDA final approval for Dapsone Gel, 5%Source: alembicpharmaceuticals.com | – |
| 25 Jun 2026 | USFDA final approval for Oseltamivir Phosphate for Oral Suspension, 6 mg/mLSource: multibagg.blob.core.windows.net | – |
What to watch next
- Expiry of the 180-day US generic market exclusivity for Bosutinib Tablets in November 2026
- Utilization of guided ₹300-350 crore capex for manufacturing capacity in FY27
- Next quarterly financial results expected to reflect contributions from new product launches
| Share price | ₹774.9 |
|---|---|
| Market capitalisation | ₹15,231.67 Cr |
| Revenue (annual) | ₹7,344.90 Cr |
| Net profit (annual) | ₹674.77 Cr |
| Revenue (latest quarter) | ₹2,149.77 Cr+16.35% vs previous quarter |
| Net profit (latest quarter) | ₹173.07 Cr-14.62% vs previous quarter |
| P/E (TTM) | 21.97×Sector 45.1× |
| Promoter holding | 69.87%0.00% QoQ |
| FII holding | 4.55%Current quarter |
Reference market data from a third-party provider, as of the story. Not a valuation or a recommendation.
Exchange filing by Alembic Pharmaceuticals Limited announcing USFDA final approval for Valganciclovir for Oral Solution. Market figures from a third-party data provider.
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