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Alembic Pharmaceuticals

By Gurminder Mangat , 9 March 2026
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Alembic Pharmaceuticals Expands U.S. Presence With Launch of New Antibiotic

Alembic Pharmaceuticals Limited has strengthened its footprint in the United States pharmaceutical market with the introduction of a new antibiotic product. The launch reflects the company’s ongoing strategy to expand its global portfolio and capitalize on opportunities in the highly competitive U.S. generics sector. By entering this therapeutic category, Alembic aims to enhance revenue diversification while addressing demand for cost-effective anti-infective treatments.

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  • Business
  • Pharmaceutical
By Manbir Sandhu , 27 February 2026
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Alembic Pharmaceuticals Secures USFDA Approval, Strengthens U.S. Generics Portfolio

Indian drugmaker Alembic Pharmaceuticals has received approval from the US Food and Drug Administration for a generic formulation, marking another step forward in its U.S. market expansion strategy. The regulatory clearance allows the company to manufacture and market the product in the United States, the world’s largest pharmaceutical market. The development underscores Alembic’s steady execution in regulated markets and reflects its continued focus on complex generics.

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  • USFDA
  • Pharmaceutical
  • Company News
By Nishant Verma , 29 January 2026
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Alembic Pharmaceuticals Secures USFDA Approval for Ophthalmic Drug

Alembic Pharmaceuticals has received approval from the U.S. Food and Drug Administration (USFDA) for a generic ophthalmic formulation, strengthening its presence in the regulated U.S. market. The approval allows the company to manufacture and market the eye treatment in the United States, expanding its specialty product portfolio. Industry analysts view the development as a positive step for Alembic’s growth strategy, particularly as demand for cost-effective eye care therapies continues to rise.

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  • Pharmaceutical
  • USFDA
By Gurleen Bajwa , 14 January 2026
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Alembic Pharmaceuticals Secures USFDA Approval for Oncology Drug, Strengthening Global Footprint

Alembic Pharmaceuticals has received approval from the United States Food and Drug Administration for a cancer treatment, marking another milestone in the company’s expanding oncology portfolio. The regulatory clearance allows Alembic to market the drug in the United States, the world’s largest pharmaceutical market. The approval underscores the company’s growing capabilities in complex generics and regulated markets.

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  • Pharmaceutical
  • USFDA
  • Company News
By Keshav Kulshrestha , 19 August 2025
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Alembic Pharmaceuticals Secures USFDA Approval for Acne Treatment

Alembic Pharmaceuticals has received approval from the U.S. Food and Drug Administration (USFDA) for its latest dermatology product, a generic version of an acne treatment, marking another milestone in the company’s growing international portfolio. The clearance strengthens Alembic’s position in the U.S. generics market, where demand for cost-effective dermatology solutions continues to expand. The drug, used in the treatment of acne vulgaris, opens new revenue opportunities for the firm while reaffirming its regulatory and manufacturing capabilities on the global stage.

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  • Pharmaceutical
  • Company News
By Gurleen Bajwa , 25 May 2025
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Alembic Pharma Secures USFDA Approval for Generic Amlodipine-Atorvastatin Tablets, Expanding Its Footprint in Hypertension Management

Alembic Pharmaceuticals has achieved a significant milestone by obtaining final approval from the US Food and Drug Administration (USFDA) for its generic formulations of amlodipine and atorvastatin tablets, key treatments for hypertension and cardiovascular health. The approval covers a wide range of dosage strengths, positioning Alembic to compete directly with branded products like Caduet in the lucrative U.S. market.

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  • Pharmaceutical
  • USFDA
By Nishant Verma , 7 May 2025
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Alembic Pharma Gains USFDA Nod for Key Heart Drug, Eyes USD 1.3 Billion Market Opportunity

Alembic Pharmaceuticals has secured final approval from the U.S. Food and Drug Administration (USFDA) to market its generic version of Ticagrelor Tablets, 90 mg, and a tentative approval for the 60 mg dosage. The drug, a therapeutic equivalent to AstraZeneca's Brilinta, is prescribed to lower the risk of cardiovascular death, heart attack, and stroke in patients with acute coronary syndrome. With an estimated combined U.S. market size of over USD 1.3 billion, this approval enhances Alembic’s presence in the U.S. generics market.

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  • Pharmaceutical
  • USFDA
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