| Market Cap | ₹50,602 CrLarge Cap |
|---|---|
| P/E TTM | 44.83Sector: 47.19 |
| 1-Year Return | 58.98%Stock Performance |
| Net Profit YoY | 47.09%Q1 FY27 Growth |
Key highlights
- Final USFDA approval for Methylprednisolone Acetate Injectable Suspension USP
- Bioequivalent to Pfizer’s Depo-Medrol with an annual US market of $214 million
- Approval covers multiple vial formats including 40 mg/mL and 80 mg/mL strengths
- Indicated for allergic states, endocrine disorders, and respiratory diseases
- Strengthens a pipeline that included 342 approved ANDAs as of June 2026
US Market Entry for Corticosteroid Injectable
Gland Pharma's newly approved Methylprednisolone Acetate Injectable is bioequivalent and therapeutically equivalent to the reference listed drug, Depo-Medrol by Pfizer Inc. The approval allows the company to market various concentrations, including 40 mg/mL and 80 mg/mL, across single-dose and multiple-dose vial configurations. This corticosteroid is indicated for a wide range of medical conditions, including allergic states, dermatologic diseases, and gastrointestinal disorders.
According to IQVIA data, the US market for Methylprednisolone injection saw sales of approximately $214 million for the twelve months ending August 2026, representing a significant commercial opportunity for Gland Pharma's generic portfolio.
Diversified Vial Formats Approved
- Single-dose vials approved in 40 mg/mL and 80 mg/mL concentrations
- Multiple-dose vials approved for 200 mg/5 mL (40 mg/mL) and 400 mg/10 mL
- Highest concentration multiple-dose vial approved at 400 mg/5 mL (80 mg/mL)
- Therapeutic applications include nervous system and ophthalmic diseases
- Clinical indications extend to renal, respiratory, and rheumatic disorders
Expanding the Global Sterile Injectable Pipeline
This regulatory milestone follows several other USFDA approvals for Gland Pharma in 2026, including Sugammadex Injection in July and Zoledronic Acid in February. As of June 30, 2026, the company's cumulative U.S. ANDA pipeline comprised 389 filings, with 342 already approved.
The steady influx of new product approvals supports management's earlier guidance of approximately 15% constant currency revenue growth for FY27. Operating primarily under a B2B model, Gland Pharma leverages its global footprint across 60 countries and its specialized focus on sterile injectables to commercialize these high-value generic products efficiently.
| Date | Announcement | Amount |
|---|---|---|
| 29 Jul 2026 | Receipt of USFDA approval for generic Sugammadex Injection (200 mg/2 mL and 500 mg/5 mL single-dose vials)Source: glandpharma.com | – |
| 04 Mar 2026 | Receipt of USFDA tentative approval for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC)Source: glandpharma.com | – |
| 06 Feb 2026 | Receipt of USFDA approval for Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/mL) single-dose bagsSource: glandpharma.com | – |
| 07 Jan 2026 | Receipt of USFDA approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)Source: ticker.finology.in | – |
| 26 Aug 2025 | Receipt of USFDA approval for Vasopressin in 5% Dextrose Injection USP (40 Units/100 mL RTU vials, and tentative approval for 20 Units/100 mL)Source: glandpharma.com | – |
| 12 Aug 2025 | Receipt of USFDA approval for Cangrelor for Injection (50 mg/vial) with 180-day generic drug exclusivitySource: indianpharmapost.com | – |
What to watch next
- Board meeting to approve Q2 and H1 FY27 financial results on November 6, 2026
- Commercial launch and distribution timelines for the Methylprednisolone vial formats
- Execution of the strategic CDMO supply agreement covering 55 injectable SKUs
| Share price | ₹3066.6 |
|---|---|
| Market capitalisation | ₹50,602.24 Cr |
| Revenue (annual) | ₹6,430.65 Cr |
| Net profit (annual) | ₹1,027.32 Cr |
| Revenue (latest quarter) | ₹1,800.27 Cr+3.30% vs previous quarter |
| Net profit (latest quarter) | ₹316.96 Cr-13.56% vs previous quarter |
| P/E (TTM) | 44.83×Sector 47.19× |
| Promoter holding | 45.75%-6.02% QoQ |
| FII holding | 10.36%Current quarter |
Reference market data from a third-party provider, as of the story. Not a valuation or a recommendation.
Exchange filing by Gland Pharma Limited announcing receipt of USFDA approval for Methylprednisolone Acetate Injectable Suspension USP. Market figures from a third-party data provider.
