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Latest news about Alembic Pharmaceuticals

Alembic Pharmaceuticals Secures USFDA Approvals for Dasatinib Tablets and Sumatriptan Injection Autoinjector 1 day ago

Alembic Pharmaceuticals has received final USFDA approvals for Dasatinib tablets in six dosages and Sumatriptan Injection USP. Dasatinib tablets, with an estimated market size of $1,017 million, are used to treat various forms of leukemia. Sumatriptan Injection, Alembic's first drug-device combination product, has a market size of $73 million. These approvals bring Alembic's total ANDA approvals to 227, strengthening its position in the U.S. generic pharmaceutical market.

Alembic Pharmaceuticals Establishes Wholly Owned Subsidiary in UAE 2 days ago

Alembic Pharmaceuticals Outlines Financial Guidance: Focus on Margins and R&D Spending 2 days ago

Alembic Pharma Reports Robust Q2 FY26 Performance with 23% Net Profit Growth 4 days ago

Alembic Pharma Secures USFDA Approval for Ticagrelor Tablets, Expanding US Market Presence 10 days ago

More news about Alembic Pharmaceuticals

18Oct 25

Alembic Pharmaceuticals Secures USFDA Approval for Triamcinolone Acetonide Injectable Suspension

Alembic Pharmaceuticals has received final approval from the USFDA for Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL, in single-dose and multiple-dose vial formats. The product is therapeutically equivalent to Bristol-Myers Squibb's Kenalog-40 Injectable Suspension. The estimated market size for this product is US$ 96.00 million for twelve months ending June 2025. With this approval, Alembic now has a total of 227 ANDA approvals from the USFDA, including 206 final approvals and 21 tentative approvals.

25Sept 25

Alembic Pharmaceuticals Secures USFDA Approval for Paroxetine Extended-Release Tablets

Alembic Pharmaceuticals has received final approval from the USFDA for Paroxetine Extended-Release Tablets in 25 mg and 37.5 mg strengths. This is the company's 226th ANDA approval, including 205 final approvals. The tablets are therapeutically equivalent to Apotex Inc.'s Paxil CR Extended-Release Tablets and are indicated for treating major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder. This approval strengthens Alembic's position in the U.S. generic pharmaceuticals market.

13Sept 25

Alembic Pharmaceuticals Receives US FDA Establishment Inspection Report for Panelav API Facilities

Alembic Pharmaceuticals Limited (APL) has received an Establishment Inspection Report (EIR) from the US FDA for its API-I and API-II facilities in Panelav. The inspection was conducted from May 26 to May 31. APL informed the BSE and NSE about the EIR on September 13. This development is significant as it indicates the facilities' compliance with cGMP regulations, potentially strengthening APL's position in the global pharmaceutical market, particularly in the United States.

09Sept 25

Alembic Pharmaceuticals Secures USFDA Approval for Phytonadione Injectable, Eyeing $44 Million in Sales

Alembic Pharmaceuticals has received USFDA approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe. The product is expected to generate $44.00 million in sales. It's used to treat hypoprothrombinemia and vitamin K-deficiency bleeding in neonates. This approval brings Alembic's total ANDA approvals from USFDA to 225, including 204 final and 21 tentative approvals.

15Aug 25

Alembic Pharmaceuticals Secures USFDA Approval for Tretinoin Cream

Alembic Pharmaceuticals has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.025%. The cream is therapeutically equivalent to Bausch Health US, LLC's Retin-A Cream and is used to treat acne vulgaris. The Tretinoin cream market has an estimated size of US$ 94.00 million for the twelve months ending June. This approval brings Alembic's total ANDA approvals from the USFDA to 224, including 202 final approvals and 22 tentative approvals.

05Aug 25

Alembic Pharma Reports Robust Q1 Performance with 10% Revenue Growth

Alembic Pharmaceuticals announced robust Q1 financial results, with revenue up 10% to ₹1,710.72 crore, EBITDA growing 20% to ₹288.00 crore, and net profit rising 15% to ₹154.38 crore. The company saw growth across all segments: India Branded Business (5%), US Generics (13%), Ex-US International Generics (21%), and API Business (1%). The company received 6 ANDA approvals and launched 4 new products in the US market. Management expects improved operating leverage from increased utilization of new facilities and cost optimization initiatives.

31Jul 25

Alembic Pharmaceuticals' Supply Chain President Shreekumar Nair Retires

Mr. Shreekumar Nair, President-Supply Chain Management and Operations at Alembic Pharmaceuticals, has retired effective July 31, 2025. The company cited superannuation as the reason for his departure. This change was announced in compliance with SEBI regulations, with official communications sent to both BSE Limited and the National Stock Exchange of India Ltd.

26Jul 25

Alembic Pharmaceuticals' Credit Rating Reaffirmed at AA+/Stable with Enhanced Bank Loan Limit

CRISIL Ratings Limited has reaffirmed Alembic Pharmaceuticals' AA+/Stable credit rating for its bank loan facilities, increasing the rated amount from Rs. 600.00 crores to Rs. 800.00 crores. The company also received USFDA approval for Carbamazepine Extended-Release Tablets USP, with an estimated market size of US$ 71.00 million.

26Jul 25

Alembic Pharmaceuticals' Credit Rating Reaffirmed at AA+/Stable with Enhanced Bank Loan Limit

CRISIL Ratings Limited has reaffirmed Alembic Pharmaceuticals Limited's AA+/Stable credit rating for its bank loan facilities. The rated amount has been increased from Rs. 600.00 crores to Rs. 800.00 crores, without changing the overall borrowing limit. This rating applies to long-term bank loan facilities and indicates high safety and low credit risk. Alembic Pharmaceuticals recently received USFDA Final Approval for Carbamazepine Extended-Release Tablets USP, bringing their total ANDA approvals to 225.

26Jul 25

Alembic Pharmaceuticals Secures US FDA Approval for Carbamazepine Extended-Release Tablets

Alembic Pharmaceuticals Limited (APL) has received US FDA approval for Carbamazepine Extended-Release Tablets USP in 100 mg, 200 mg, and 400 mg strengths. The drug, equivalent to Novartis' Tegretol-XR, is used as an anticonvulsant and for treating trigeminal neuralgia pain. The approved tablets have an estimated market size of US$ 71.00 million for the twelve months ending March 2025. This approval brings Alembic's total FDA-approved ANDAs to 225, including 202 final approvals and 23 tentative approvals.

03Jul 25

Alembic Pharma's US Unit Acquires Utility Therapeutics for $12 Million

Alembic Pharmaceuticals' US unit has acquired Utility Therapeutics for $12 million. This strategic move aims to strengthen Alembic's presence in the US market and expand its portfolio of urinary tract infection (UTI) treatments. The acquisition is expected to broaden Alembic's product range, enhance its position in the US pharmaceutical market, and potentially increase revenue streams from UTI drug segments.

30Jun 25

Alembic Pharma Secures USFDA Approval for $29 Million Market Opportunity

Alembic Pharmaceuticals has received final approval from the USFDA for Doxorubicin Hydrochloride Liposome Injection, a cancer treatment medication. The approval opens up a market opportunity estimated at $29.00 million. This liposomal formulation is designed to enhance efficacy while potentially reducing side effects compared to conventional doxorubicin formulations. The approval strengthens Alembic's presence in the U.S. pharmaceutical market and showcases its capabilities in advanced drug delivery systems.

18Jun 25

Alembic Pharmaceuticals Secures Establishment Inspection Report for API-III Facility

Alembic Pharmaceuticals has obtained an Establishment Inspection Report (EIR) for its API-III facility in Karakhadi. This indicates the facility has met regulatory compliance and quality standards, potentially boosting market confidence and opening opportunities for expansion. The EIR is a positive development for Alembic, reflecting its commitment to maintaining high-quality standards in pharmaceutical manufacturing.

02Jun 25

Alembic Pharmaceuticals Facility Receives 4 USFDA Observations Following CGMP Inspection

Alembic Pharmaceuticals' API-I & II Panelav facility underwent a routine CGMP inspection by the USFDA, resulting in four observations. The specific details of these observations have not been disclosed. The company will likely need to respond with corrective actions to address the USFDA's concerns.

30May 25

Alembic Pharma Stock Rises on FDA Approval for Blood Cancer Drug

Alembic Pharmaceuticals has received FDA approval for Bosutinib Tablets (100 mg and 500 mg) to treat chronic myelogenous leukemia. The drug's estimated market size is $291.00 million for the twelve months ending March 2025. The company's shares rose 1.10% following the announcement, reflecting positive investor sentiment.

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.

07May 25

Alembic Pharma Outlines R&D Expense Plans for Coming Years

Alembic Pharmaceuticals has disclosed its R&D expense projections for the upcoming fiscal years. The company plans to invest ₹500 crores in FY 2024-25 and ₹600-650 crores in FY 2025-26. This increased spending signals a strong commitment to innovation, potential market expansion, and a long-term growth strategy. The move aligns with industry trends of focusing on R&D to maintain competitiveness in the pharmaceutical sector.

07May 25

Alembic Pharma Eyes EBITDA Margin Boost Amid Optimized R&D Spending

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.

06May 25

Alembic Pharmaceuticals: Q4 Profit Down 12%, Revenue Up, ₹11 Dividend Proposed

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.

01Apr 25

Alembic Pharmaceuticals Secures USFDA Approval for Pantoprazole Sodium Injection

Alembic Pharmaceuticals has received final USFDA approval for Pantoprazole Sodium for Injection, 40 mg/vial. The drug, equivalent to Wyeth's Protonix I.V., is used to treat GERD and other gastric conditions. The estimated market size for this product is $48 million. This approval brings Alembic's total ANDA approvals to 221, including 195 final and 26 tentative approvals.

24Mar 25

Alembic Pharma's API-III Facility Clears USFDA Inspection with Flying Colors

Alembic Pharmaceuticals' API-III facility in Karakhadi successfully cleared a USFDA inspection with no Form 483 observations. This outcome demonstrates the facility's high-quality standards and regulatory compliance, potentially boosting market confidence and providing a competitive advantage in the pharmaceutical industry.

21Mar 25

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.