Alembic Pharma has received approval from the US Food and Drug Administration (FDA) to manufacture a drug used for treating both thyroid disorders and certain types of cancer, marking a significant milestone in their pharmaceutical portfolio expansion.
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Alembic Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) to produce a generic version of Synthroid, a widely-used thyroid medication. With an estimated market size of $1.87 billion by March 2026, this approval marks another milestone for Alembic, which already holds 239 US FDA Abbreviated New Drug Application (ANDA) approvals.
Alembic Pharma aims to boost US sales by focusing on branded drugs, launching Pivya for UTIs and women's health. In the previous financial year, their US business grew by 13%, and they aim for mid-teens growth in FY27.
Alembic Pharmaceuticals anticipates a 10-15% growth in the US market by FY26, achieved through product launches and market share expansion. The company also aims to achieve a 20% EBITDA margin within the next 2-3 years, despite facing pressure from increased research and development costs and investments in the US.
Alembic Pharmaceuticals is expanding its reach in the U.S. market by introducing a new branded drug, aiming to leverage this venture as a significant catalyst for future growth.
Alembic Pharmaceuticals aims for a substantial revenue increase of around 10% by FY27, with international generic drugs and APIs showing growth rates in the low to mid-teens and high single/low double digits respectively, mirroring the Indian market trends.
Alembic Pharma experienced a 6% drop in share price today, reflecting the overall sluggishness in the healthcare sector. While Q4FY26 net profit grew, no significant new catalysts were identified to boost the company's performance moving forward.
Alembic Pharma intends to invest approximately 800 crore INR in research and development, aiming for a 9% revenue return. In the fiscal year 2027, capital expenditure is projected between 300-350 crore INR for capacity enhancement and replacements.
Alembic Pharma has successfully passed the Good Manufacturing Practice (GMP) inspection by Brazil's ANVISA for their API III facility on May 11-15, 2026. Notably, multiple Active Pharmaceutical Ingredients (APIs) were approved without any observations, demonstrating the facility's compliance and efficiency.
Alembic Pharma reported a 29% increase in Q4 net profit, reaching ₹202 crore, with revenue growing 4.4% to ₹1,848 crore. However, the company's EBITDA dropped by 16.2%, and the EBITDA margin declined from 15.4% to 12.3% year-over-year.
Alembic Pharmaceuticals has shared its Q4 financial results, revealing essential performance indicators. Stay tuned for more insights on their quarterly performance.
Alembic Pharmaceuticals' Q4 FY26 revenue increased by 4% year-over-year, reaching INR 1,848 crore. The company's net profit saw a significant jump of 29% YoY to INR 203 crore. Additionally, they have recently launched Pivya in the US market, expanding their global presence.
Alembic Pharmaceuticals reported a 4.5% year-on-year increase in their Q4 revenue, reaching ₹18.5 billion compared to ₹17.7 billion in the same quarter last year.
Alembic Pharmaceuticals has secured US Food and Drug Administration (FDA) approval for its Karakhadi Injectable Facility F-III, following a successful inspection that took place from February 9 to 18, with the EIR issued on May 13.
Alembic Pharmaceuticals has received a tentative approval from the US FDA for Darolutamide, a potential blockbuster drug with an estimated $3.155 billion market value in the US by 2026. This is a significant milestone for the company's growth prospects.
Alembic Pharmaceuticals conducted a significant block trade on NSE, exchanging approximately 201,791 shares at Rs. 769.05 each, amounting to a total value of around Rs. 15.5 crores.
Alembic Pharma has received USFDA approval for Fingolimod Capsules, a multiple sclerosis treatment, marking an entrance into the $145M US market by 2025. With over 237 ANDA approvals under its belt, Alembic continues to expand its pharmaceutical portfolio.
Alembic Pharmaceuticals establishes a German subsidiary, Alembic Pharmaceuticals GmbH, to tap into the local market for potential growth in promoting and distributing their pharmaceutical products.
Alembic Pharmaceuticals secures U.S. FDA approval for their Methotrexate Injection, confirming it is equivalent to a drug previously produced by Hospira. This marks the company's 236th U.S. FDA-approved Abbreviated New Drug Application (ANDA).
Alembic Pharma has secured USFDA approval for Dapagliflozin tablets, a diabetes drug similar to AstraZeneca's Farxiga. This move grants them a 180-day shared exclusivity in the market, targeting potential sales of up to $10.5 billion by December 2025.