Alembic Pharma Share Price Jumps Over 3% After USFDA Nod for Cancer Drug

Market Performance

Alembic Pharma's share price surged in early trading on June 30, reflecting positive sentiment following a key regulatory milestone.

• Share price at 09:21 hrs: ₹1,002.80
• Day's gain: ₹30.95
• Percentage rise: +3.18%

This upward movement in Alembic Pharma's share price was attributed to the US FDA's approval of a new product, which strengthened the company's position in the oncology drug segment.

Main Development

Alembic Pharmaceuticals has received the US Food and Drug Administration's (USFDA) final nod for its abbreviated new drug application (ANDA) for:

• Doxorubicin Hydrochloride Liposome Injection
  • Dosages: 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL)
  • Form: Single-dose vials

This drug is therapeutically equivalent to the reference listed drug (RLD) — Doxil Liposome Injection — developed by Baxter Healthcare Corporation.

Product Significance

The injection is used for the treatment of:

• Ovarian Cancer
• AIDS-Related Kaposi's Sarcoma
• Multiple Myeloma

This marks a significant milestone for Alembic Pharma in its oncology portfolio and reinforces its ability to meet regulatory standards in highly specialized drug formulations.

Company Details

Alembic Pharmaceuticals has consistently expanded its portfolio in the US generics market.

• Total USFDA ANDA approvals: 224
  • Final approvals: 201
  • Tentative approvals: 23

Earlier this month, on June 18, the company also received an Establishment Inspection Report (EIR) from the USFDA following an inspection at its API-III facility in Karakhadi. The inspection was conducted between March 17 to March 21, 2025.

These regulatory milestones reflect the company's commitment to maintaining global manufacturing and quality standards.

Stock Performance Snapshot

• 52-week high: ₹1,296.15 (recorded on October 9, 2024)
• 52-week low: ₹725.60 (recorded on March 3, 2025)
• Current price vs 52-week high: 25.02% below
• Current price vs 52-week low: 33.94% above

The fluctuation in Alembic Pharma's share price over the year highlights both volatility and investor optimism during regulatory breakthroughs.

Market Capitalisation

As of June 30:

• Market cap: ₹19,102.99 Crore

This positions Alembic Pharma among the prominent mid-cap pharmaceutical players in India.

Summary

Alembic Pharma's share price gained 3.18% following the USFDA approval of its Doxorubicin Hydrochloride Liposome Injection. This development strengthens the company's presence in the US oncology generics market. With 224 ANDA approvals and a positive inspection outcome for its API facility, Alembic Pharmaceuticals continues to demonstrate its regulatory and manufacturing competence.

The current stock movement reflects investor confidence in Alembic's growing pipeline and execution capabilities, particularly in high-value therapeutic segments.