Alembic Pharmaceuticals Ltd
Alembic Pharmaceuticals Limited receives USFDA approval for Methotrexate Injection USP.
ORDERS
▲ Positive Development
LOW RISK
📅 Filed on BSE: 16 Apr 2026, 11:14 AM IST · BSE ID: 53535f8b-2c17-4dbd-9390-2028b9aea918
View Original BSE Filing (PDF)
⚡ Quick Answer
Alembic Pharmaceuticals Ltd secured its 219th final USFDA approval for Methotrexate Injection USP in two formulations. This marks a significant milestone, bringing their cumulative total USFDA approvals to 236, including 18 tentative ones. The approval for Methotrexate Injection USP, therapeutically equivalent to Hospira's product, reinforces Alembic's strong track record in the pharmaceutical market.
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In Simple Terms
Alembic just won approval from the US drug regulator to sell a generic cancer and arthritis injection in America.
🤖 AI Summary
- USFDA grants final approval for Methotrexate Injection USP in two vial strengths
- Product therapeutically equivalent to Hospira reference listed drug formulation
- Indicated for seven neoplastic diseases and three non-cancer conditions
- Represents Alembic's 219th final ANDA approval from USFDA
🔢 Key Numbers — exact figures from BSE filing, not rounded
Cumulative ANDA approvals from USFDA
236 total (218 final, 18 tentative)
New final ANDA approval count
219th final approval
🏢 How This Affects the Company
Approval expands Alembic's US generic injectable portfolio and commercialization pathway in the oncology and rheumatology segments. Access to established markets for methotrexate injection strengthens presence in high-volume therapeutic categories.
👥 What This Means For Shareholders
✅
Action Required
No action required. Monitor earnings disclosures for methotrexate injection revenue contribution starting next quarter.
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Who Is Affected
All equity shareholders benefit from expanded US generic injectable revenue stream. Institutional investors tracking ANDA approval momentum see portfolio deepening aligned with prior strategy.
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Management Signal
Consistent execution on US generic injectables strategy demonstrates management focus on scaling ANDA approvals in high-volume, non-specialized therapeutics.
For information only. Not investment advice. ForgeUp is not SEBI-registered.
👁 Watch List — track these upcoming events
Q1 FY27 earnings call — clarify methotrexate injection launch timeline and expected revenue ramp
Next ANDA approval announcement — track approval cadence and pipeline status updates
US pricing and market share data — monitor competitive positioning versus other methotrexate injectable suppliers
LOW RISK
Methotrexate is off-patent, mature molecule with established demand. Regulatory approval confirmed; standard market competition risk.
💡 Investor Takeaway
Alembic secured USFDA final approval for Methotrexate Injection USP—bringing its cumulative ANDA total to 236 approvals (218 final, 18 tentative). Approval enables US market entry for cancer and arthritis indication, leveraging established demand in large patient populations.
⚖️ Strengths & Concerns
✅ Positives
- Cumulative 236 ANDA approvals from USFDA demonstrates consistent regulatory approval track record and manufacturing compliance.
- Methotrexate injection addresses large patient populations across oncology and rheumatology — established, non-patent-dependent markets.
📅 Company Track Record
Alembic Pharmaceuticals, founded in 1907, is a vertically integrated pharmaceutical manufacturer with over 5,500-person domestic field force. Company maintains USFDA-approved manufacturing facilities and markets branded generics across India and internationally via Reuters:ALEM.NS, Bloomberg:ALPM.
Based on publicly available historical data. For context only.
❓ Frequently Asked Questions
What did Alembic Pharmaceuticals receive approval for from the USFDA?
Alembic Pharmaceuticals received final USFDA approval for Methotrexate Injection USP in two formulations: 50 mg/2 mL Multi-Dose Vials and 1g/40 mL Single-Dose Vials.
What is the significance of this USFDA approval for Alembic Pharmaceuticals?
This is Alembic Pharmaceuticals' 219th final ANDA approval, contributing to their cumulative total of 236 USFDA approvals (218 final, 18 tentative).
What is Methotrexate Injection USP used for?
Methotrexate Injection USP treats various cancers including acute lymphoblastic leukemia, non-Hodgkin lymphoma, osteosarcoma, and breast cancer, as well as conditions like rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriasis.
How many final ANDA approvals has Alembic Pharmaceuticals received from the USFDA?
Alembic Pharmaceuticals has received 218 final ANDA approvals from the USFDA, with this latest approval for Methotrexate Injection USP being their 219th final approval.
Questions based on this BSE filing only. For information purposes.