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Alembic Pharmaceuticals has secured final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Macitentan Tablets, 10 mg. The regulatory nod marks a strategic milestone for the company’s expanding cardiovascular and pulmonary therapeutic portfolio, reinforcing its position in the high-value US generics market.
Key Approval Highlights
The approval pertains to Macitentan Tablets, 10 mg, a generic version of Actelion Pharmaceuticals’ Opsumit, used in the treatment of pulmonary arterial hypertension (PAH)
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The drug works by relaxing blood vessels in the lungs, reducing pulmonary blood pressure and improving exercise capacity
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According to IQVIA, the US market for Macitentan tablets is estimated to be over USD 600 million annually
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Alembic’s formulation is therapeutically equivalent to the reference listed drug, ensuring bioequivalence and clinical parity
Strategic Significance for Alembic
Portfolio Expansion
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This approval adds to Alembic’s growing pipeline of complex generics in the cardiopulmonary space
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The company now has 224 ANDA approvals, including 202 final and 22 tentative, reflecting robust regulatory traction
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Macitentan joins Alembic’s list of high-barrier products, which include anti-cancer, anti-diabetic, and CNS therapies
Market Penetration Potential
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With limited generic competition for Macitentan in the US, Alembic is well-positioned to capture meaningful market share
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The drug’s once-daily dosing and long half-life make it a preferred choice among physicians, enhancing commercial viability
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Alembic’s vertically integrated manufacturing and supply chain capabilities support rapid scale-up and distribution
Financial Implications
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The approval is expected to contribute positively to Alembic’s US revenue, which grew 14.18 percent year-on-year in Q1 FY26
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The company reported consolidated net profit of ₹156.63 crore and revenue of ₹1,710.72 crore for the quarter ending June 2025
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Analysts anticipate incremental earnings from Macitentan to reflect in FY26’s second-half performance
Regulatory and Competitive Landscape
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Macitentan is classified as a high-risk drug due to its impact on liver enzymes and potential teratogenicity, requiring Risk Evaluation and Mitigation Strategy (REMS) compliance
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Alembic’s approval indicates successful alignment with stringent USFDA safety and labeling protocols
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The generic launch may face initial resistance from brand-loyal prescribers, but pricing advantage and therapeutic equivalence are expected to drive adoption
Industry Reaction and Stock Movement
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Shares of Alembic Pharmaceuticals rose over 2 percent on August 18 following the announcement, trading at ₹969.75 on NSE
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Market participants view the approval as a signal of Alembic’s capability to navigate complex regulatory pathways and deliver differentiated products
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The news comes amid broader sector optimism, with Indian pharma firms increasingly targeting niche therapies and specialty generics
Forward Outlook
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Alembic is expected to initiate commercial rollout in Q4 FY26, subject to final packaging and distribution readiness
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The company is also pursuing approvals for other PAH-related therapies, including Ambrisentan and Riociguat, to build a comprehensive pulmonary care portfolio
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Long-term growth will depend on sustained regulatory success, pricing discipline, and formulary access in the US market
Sources: Rediff MoneyWiz, EquityPandit, Business Standard, India Infoline, Medical Dialogues, Economic Times.
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