| Market Cap | ₹17,822.38 CrPharmaceuticals |
|---|---|
| PE TTM | 21.12Sector 37.96 |
| Promoter Holding | 69.87%No Change QoQ |
| Day RSI | 76.25Overbought Zone |
Key highlights
- Final USFDA approval granted for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)
- Product is therapeutically equivalent to Alcon Laboratories' Pataday Once Daily Relief
- Estimated US market size for the product is $20 million for the year ending September 2026
- Alembic now holds a cumulative total of 248 ANDA approvals from the USFDA
- Development was completed in collaboration with Orbicular Pharmaceutical Technologies Pvt Ltd
Approval Details and Therapeutic Indication
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7%. This over-the-counter formulation is the generic equivalent of Pataday Once Daily Relief by Alcon Laboratories. The solution is indicated for the temporary relief of itchy eyes caused by common allergens such as pollen, ragweed, grass, and animal dander.
Developed in collaboration with Orbicular Pharmaceutical Technologies, this approval marks a continuation of Alembic's strategy to expand its specialized ophthalmic portfolio in the North American market.
Expanding Global Regulatory Footprint
- The company has reached a cumulative total of 248 USFDA approvals as of November 2026
- Pipeline includes 229 final approvals and 19 tentative approvals for various ANDAs
- Recent October 2026 approvals include Venetoclax Tablets and Valganciclovir Oral Solution
- Company maintains a total pipeline of 283 ANDA filings with the USFDA to date
- Alembic has successfully launched 188 products in the US market as of late 2026
Financial Performance and Strategic Guidance
The approval comes as Alembic reports strong financial growth, with September 2026 quarter revenue rising 36.3% year-on-year to ₹2,603.48 crore. Net profit for the same period increased by 81.5% to ₹335.17 crore, supported by an improved operating profit margin of 21.6%. Management has recently raised its full-year FY 2027 revenue growth guidance to 20%–25%, up from mid-teens.
To sustain this momentum, the company plans an R&D investment of ₹750 crore to ₹800 crore for FY 2027, focusing on high-value generics and complex formulations.
| Date | Announcement | Amount |
|---|---|---|
| 30 Oct 2026 | Received USFDA final approval for Venetoclax Tablets, 10 mg, 50 mg, and 100 mgSource: alembicpharmaceuticals.com | – |
| 27 Oct 2026 | Received USFDA final approval for Valganciclovir for Oral Solution, 50 mg/mLSource: alembicpharmaceuticals.com | – |
| 17 Oct 2026 | Received USFDA final approval for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%Source: alembicpharmaceuticals.com | – |
| 28 Jul 2026 | Received USFDA final approval for Prucalopride Tablets, 1 mg and 2 mgSource: alembicpharmaceuticals.com | – |
| 18 Jul 2026 | Partner NATCO Pharma received USFDA tentative approval for Olaparib Tablets, 100 mg and 150 mgSource: alembicpharmaceuticals.com | – |
| 19 Jun 2026 | Received USFDA tentative approval for Binimetinib Tablets, 45 mgSource: alembicpharmaceuticals.com | – |
What to watch next
- Commercial launch of Olopatadine Hydrochloride Ophthalmic Solution in the US market
- Final approval for the 19 tentative ANDAs currently pending with the USFDA
- Execution of the ₹300 crore to ₹350 crore capital expenditure plan for FY 2027
- Upcoming board review for the next set of quarterly financial results in early 2027
| Share price | ₹906.7 |
|---|---|
| Market capitalisation | ₹17,822.38 Cr |
| Revenue (annual) | ₹7,344.90 Cr |
| Net profit (annual) | ₹674.77 Cr |
| Revenue (latest quarter) | ₹2,603.48 Cr+21.11% vs previous quarter |
| Net profit (latest quarter) | ₹335.17 Cr+93.66% vs previous quarter |
| P/E (TTM) | 21.12×Sector 37.88× |
| 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 the final USFDA approval for Olopatadine Hydrochloride Ophthalmic Solution. Market figures from a third-party data provider.
