Alembic Pharma Stock Rises on FDA Approval for Blood Cancer Drug May 30, 2025
More news about Alembic Pharmaceuticals
30May 25
Alembic Pharma Secures USFDA Approval for Bosutinib Tablets
Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (USFDA) for its Bosutinib Tablets. The approved product, used in treating certain types of leukemia, has reported U.S. sales of $291.00 million. This approval enhances Alembic's product portfolio and opens up opportunities in the oncology segment.
15May 25
Alembic Pharmaceuticals Secures USFDA Approval for Rivaroxaban Tablets
Alembic Pharmaceuticals has received final approval from the USFDA for its Rivaroxaban Tablets. This anticoagulant medication, used to treat and prevent blood clots, has a US market size of approximately $445.00 million. The approval enhances Alembic's presence in the US generic drug market and demonstrates its capability in developing complex generic formulations.
Alembic Pharmaceuticals anticipates improved EBITDA margins in upcoming quarters and years, driven by optimized R&D spending. This outlook comes despite recent financial results showing mixed performance, with Q4 FY2024 revenue up 6.88% YoY but EBITDA and net profit declining significantly. The company's EBITDA margin contracted from 19.94% to 11.61%. Management's strategy focuses on balancing innovation with profitability through R&D optimization, aiming to enhance overall profitability and competitive position.
06May 25
Alembic Pharma Sets Ambitious Global Expansion Targets for FY26
Alembic Pharmaceuticals has announced plans to launch over 40 new products across international markets including the EU, Canada, Australia, and South Africa by FY2026. The strategy focuses on diversifying product portfolio across various dosage forms and emphasizes timely market entry. This move aims to strengthen Alembic's global presence, expand its market footprint, and drive long-term growth in the international pharmaceutical landscape.
Alembic Pharmaceuticals announced its Q4 FY23 results, showing a 16.70% YoY increase in revenue to ₹1,769.60 crore, but an 11.80% YoY decrease in net profit to ₹157.00 crore. EBITDA grew 4.60% to ₹272.00 crore, with the EBITDA margin narrowing to 15.40%. The company proposed a dividend of ₹11.00 per share for FY23.
02May 25
Alembic Pharmaceuticals Secures FDA Approval for Generic Heart Attack Prevention Drug
Alembic Pharmaceuticals has received FDA approval for its generic version of Ticagrelor Tablets. The 90 mg strength received final approval, while the 60 mg strength got tentative approval. This generic is equivalent to AstraZeneca's Brilinta Tablets. The estimated market size for 90 mg and 60 mg strengths is US$ 1,062.00 million and US$ 242.00 million respectively. Ticagrelor tablets are used for various cardiovascular conditions. This approval brings Alembic's total ANDA approvals from FDA to 222, including 197 final and 25 tentative approvals.
02May 25
Alembic Pharmaceuticals Secures USFDA Approval for Ticagrelor Tablets
Alembic Pharmaceuticals has received final approval from the USFDA for its Ticagrelor tablets, an antiplatelet medication used to prevent blood clots. This approval allows Alembic to enter the U.S. market for this product, which has annual sales of approximately USD 1.00 billion. The approval marks a significant milestone in Alembic's U.S. market expansion strategy and could potentially boost its revenue from U.S. operations.
26Apr 25
Alembic Pharma Boosts Production Capacity with New ₹205.00 Crore Facility in Madhya Pradesh
Alembic Pharmaceuticals Limited has launched a new formulation manufacturing facility in Pithampur, Madhya Pradesh, with an investment of ₹205 crore. The facility, operational from April 26, 2025, aims to support business expansion and bring third-party production in-house. Financed through internal accruals and borrowings, this strategic move is expected to enhance the company's production capabilities and operational efficiency.
17Apr 25
Alembic Pharmaceuticals Secures FDA Approval for Carbamazepine Tablets
Alembic Pharmaceuticals has received final FDA approval for Carbamazepine Tablets USP, 200 mg, an anticonvulsant and pain treatment medication. The drug enters a market with an estimated size of $32.00 million for the 12 months ending December 2024. This approval strengthens Alembic's U.S. market presence and expands its product portfolio.
Alembic Pharmaceuticals Clears USFDA Inspection at Karakhadi API Facility
Alembic Pharmaceuticals Limited successfully completed a USFDA GMP inspection at its API-III facility in Karakhadi, Gujarat, from March 17-21, 2025. The inspection concluded with no Form 483 observations, indicating high compliance with USFDA standards. This outcome demonstrates the company's commitment to quality control and regulatory adherence, potentially boosting market confidence and ensuring operational continuity.
18Mar 25
Alembic Pharmaceuticals Expands Global Footprint with New US Subsidiary
Alembic Pharmaceuticals has established a new wholly-owned subsidiary, Alembic Lifesciences Inc, in Delaware, USA, through its subsidiary Alembic Global Holding SA. The company also announced the appointment of Ms. Geeta Goradia as an Independent Director, approved by shareholders with 94.70% votes in favor.
17Mar 25
Alembic Pharmaceuticals Expands US Presence with New Subsidiary
Alembic Pharmaceuticals Limited has incorporated a new wholly-owned subsidiary, Alembic Lifesciences Inc., in Delaware, USA on March 13, 2025. The subsidiary, operating under Alembic Global Holding SA, aims to strengthen the company's presence in the US pharmaceutical market. While specific operational details are undisclosed, the move is likely intended to enhance research capabilities, expand product portfolio, and improve US distribution. Alembic Global Holding SA will make a remittance for 100% shareholding, though the investment amount is unspecified.
10Mar 25
Alembic Pharmaceuticals Receives Form 483 After USFDA Inspection
Alembic Pharmaceuticals' bioequivalence facility in Vadodara, Gujarat, underwent a USFDA inspection from March 3 to March 7. The inspection concluded with a Form 483 containing one procedural observation. This outcome is relatively positive for the company, as it suggests a minor issue that may be addressable without significant operational disruption. The bioequivalence facility is crucial for Alembic's generic drug development process. The company is expected to respond with a plan to address the observation, which will be important for maintaining regulatory compliance and ensuring smooth operations.
07Mar 25
Alembic Pharmaceuticals Receives Form 483 After USFDA Inspection at Bioequivalence Facility
Alembic Pharmaceuticals' bioequivalence facility in Vadodara underwent a USFDA inspection from March 3-7, 2025, resulting in a Form 483 with one procedural observation. The company has committed to providing a comprehensive response within the stipulated timeframe and maintains its dedication to high-quality standards and compliance.