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APLLTDNSEAlembic Pharmaceuticals Limited· PharmaceuticalsMediumPositive
Announced Thu, 16 Apr · 11:17 IST

USFDA Final Approval for Methotrexate Injection

Regulatory Product ApprovalBusiness Updates View source PDF

APLLTD · price

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▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.

Price reaction · full curve 14 horizons · vs prior close
+7.0%1-day move
₹730.00
prior close
₹748.00
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AI summary

Alembic Pharmaceuticals received USFDA final approval for its ANDA for Methotrexate Injection USP in 50 mg/2 mL multi-dose and 1g/40 mL single-dose vials. The product is therapeutically equivalent to Hospira's reference listed drug and is indicated for cancers (leukemia, lymphoma, osteosarcoma, breast cancer, etc.), rheumatoid arthritis, and psoriasis. This takes Alembic's cumulative ANDA count to 236 (218 final, 18 tentative), strengthening its US generics pipeline.

Likely market impact

Positive — expands Alembic's USFDA-approved portfolio, enabling a new product launch in the high-value US generics market and boosting future revenue potential.