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Alembic Pharmaceuticals Limited (aplltd) Secures USFDA Final Approval for Levothyroxine Sodium Tablets

Alembic Pharmaceuticals Limited (APLLTD) announces USFDA final approval for its Levothyroxine Sodium Tablets, expanding its generic drug portfolio.

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Alembic Pharmaceuticals Limited Aplltd USFDA Approval Levothyroxine Sodium Tablets

Alembic Pharmaceuticals Limited (APLLTD) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Levothyroxine Sodium Tablets USP in various strengths. This approval marks a significant milestone for Alembic, as the approved ANDA is therapeutically equivalent to Synthroid Tablets, a leading reference listed drug product by AbbVie, Inc. (AbbVie).

Market Potential

Levothyroxine Sodium Tablets USP are indicated for replacement therapy in primary, secondary, and tertiary congenital or acquired hypothyroidism, and as an adjunct in the management of thyrotropin-dependent well-differentiated thyroid cancer. The market for these tablets is estimated to be worth US$ 1,869 million for the twelve months ending March 2026, according to IQVIA.

Company Milestone

This approval adds to Alembic’s extensive portfolio of ANDA approvals, bringing the cumulative total to 239, including 220 final approvals and 19 tentative approvals. Alembic Pharmaceuticals Limited, established in 1907, is a vertically integrated research and development pharmaceutical company headquartered in India. The company is a leader in branded generics and has state-of-the-art research and manufacturing facilities approved by regulatory authorities in many developed countries, including the USFDA.

As Alembic continues to expand its generic drug portfolio, this latest approval is expected to enhance its market presence and contribute to its growth strategy in the global pharmaceutical market.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited belongs to the › sector. Here’s a quick read on where the business and the stock stand today.

APLLTD
Healthcare › Drug Manufacturers - Specialty & Generic
APPROACHING RESISTANCE
80
Fundamental
70
Technical
76
Overall

1W -3.17%
1M +3.22%
3M +2.82%
P/E: 23.7 Cap: Mid
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

Alembic trades in the lower quarter of its 52-week range. Thin margins at 9.1% leave limited room for error — any demand softness or cost spike hits the bottom line hard. Revenue grows at 10.1% and profits at 25.4% CAGR. The market consistently rewards this kind of compounding. Buyers show up with 1.7x the volume of sellers. Moreover, they dominated on 18 of recent sessions versus 12 for sellers — a healthy accumulation pattern. Revenue grows at 10.1% and profits at 25.4%. The business is in good shape. Moreover, a stock that does not move despite strong fundamentals often offers better value than one already priced for perfection. Check Fundamentals of Alembic Pharmaceuticals Limited.

APLLTD

Alembic Pharmaceuticals Limited (aplltd) Q1 FY27: Revenue Surges 26% Yoy

Alembic Pharmaceuticals Limited (APLLTD) reports a 26% YoY revenue surge in Q1 FY27, driven by strong growth in India Branded Business and US Formulation.

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Alembic Pharmaceuticals Limited Q1 FY27 Results

Alembic Pharmaceuticals Limited (APLLTD) has reported impressive financial results for Q1 FY27, with a 26% year-on-year growth in revenue, reaching INR 21.50 billion. This robust performance is primarily driven by significant growth in its India Branded Business and US Formulation segments. The company’s strategic expansion and product pipeline advancements have played a crucial role in achieving these results.

India Branded Business

The India Branded Business recorded a 7% year-on-year growth, with quarterly revenues of INR 6.42 billion. Alembic’s focus on expanding its market share and introducing new products has contributed to this growth. The company ranks 21st in the Indian Pharmaceutical Market (IPM) and holds a 1.1% market share.

US Formulation

The US Formulation segment witnessed a remarkable 49% year-on-year growth, driven by key product launches and increased volumes. Alembic has launched seven new products in Q1 FY27, bringing the total number of commercialized products to 185. The company’s pipeline includes 15+ product launches expected in FY27, showcasing its commitment to strategic growth in the US market.

Overall Performance

Alembic Pharmaceuticals Limited’s overall revenue for Q1 FY27 stood at INR 21.50 billion, with a strong EBITDA margin of ~24%. The company’s net profit after tax (PAT) was reported at INR 1.73 billion, reflecting effective cost management and operational efficiency. The company continues to invest in its R&D capabilities, with a focus on peptide development and increased filings, supporting its long-term growth strategy.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited belongs to the › sector. Here’s a quick read on where the business and the stock stand today.

APLLTD
Healthcare › Drug Manufacturers - Specialty & Generic
APPROACHING RESISTANCE
80
Fundamental
70
Technical
76
Overall

1W -3.17%
1M +3.22%
3M +2.82%
P/E: 23.7 Cap: Mid
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

Alembic posts a 4.7% three-month gain, but softens in the last few weeks. Thin margins at 9.2% leave limited room for error — any demand softness or cost spike hits the bottom line hard. Not a single revenue dip or loss quarter in five years — this is a business built to last through cycles. The stock gives back 2.2% in the last month despite a positive three-month run. As a result, the earlier momentum appears to be fading. Revenue grows at 9.5% and profits at 25.4%, and the dividend yield stands at 1.51%. The business is in good shape. Moreover, a stock that does not move despite strong fundamentals often offers better value than one already priced for perfection. Check Fundamentals of Alembic Pharmaceuticals Limited.

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APLLTD

Alembic Pharmaceuticals Limited Receives USFDA Final Approval for Prucalopride Tablets

Alembic Pharmaceuticals Limited (APLLTD) secures USFDA final approval for Prucalopride Tablets, 1 mg and 2 mg, expanding its generic drug portfolio.

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Alembic Pharmaceuticals Limited Aplltd USFDA Approval Prucalopride

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Prucalopride Tablets, 1 mg and 2 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA Inc. Prucalopride tablets are serotonin-4 receptor agonists indicated for the treatment of chronic idiopathic constipation (CIC) in adults. This approval marks a significant milestone for Alembic, as Prucalopride Tablets, 1 mg and 2 mg, have an estimated market size of US$ 100 million for twelve months ending March 2026 according to IQVIA.

Expansion of Generic Drug Portfolio

This approval adds to Alembic’s cumulative total of 245 ANDA approvals (225 final approvals and 20 tentative approvals) from USFDA. The company’s strong presence in the generic drug market is further reinforced by this development. Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

Leadership in Branded Generics

Alembic’s state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. The company is one of the leaders in branded generics in India. Alembic’s brands, marketed through a field force of over 5500, are well recognized by doctors and patients. This latest approval will enable Alembic to expand its market reach and contribute to the treatment of chronic idiopathic constipation in the US market.

For more information, contact Isha Lamba at +91 22-66951652 or email [email protected].

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited belongs to the › sector. Here’s a quick read on where the business and the stock stand today.

APLLTD
Healthcare › Drug Manufacturers - Specialty & Generic
APPROACHING RESISTANCE
80
Fundamental
70
Technical
76
Overall

1W -3.17%
1M +3.22%
3M +2.82%
P/E: 23.7 Cap: Mid
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

Alembic moves sideways over three months, with neither buyers nor sellers taking control. Thin margins at 9.2% leave limited room for error — any demand softness or cost spike hits the bottom line hard. Not a single revenue dip or loss quarter in five years — this is a business built to last through cycles. Buyers show up with 2.4x the volume of sellers. Moreover, they dominated on 16 of recent sessions versus 14 for sellers — a healthy accumulation pattern. Revenue grows at 9.5% and profits at 25.4%. The business is in good shape. Moreover, a stock that does not move despite strong fundamentals often offers better value than one already priced for perfection. Check Fundamentals of Alembic Pharmaceuticals Limited.

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APLLTD

Alembic Pharmaceuticals Limited (aplltd) Secures USFDA Final Approval for Dapsone Gel, 5%

Alembic Pharmaceuticals Limited (APLLTD) announces USFDA final approval for Dapsone Gel, 5%, expanding its generic drug portfolio.

priyanka verma tradealone

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Alembic Pharmaceuticals Limited Aplltd USFDA Approval Dapsone Gel 5

Alembic Pharmaceuticals Limited (APLLTD) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapsone Gel, 5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Aczone Gel, 5%, of Almirall, LLC. This marks a significant milestone for Alembic as Dapsone Gel is indicated for the topical treatment of acne vulgaris. This approval adds to Alembic’s cumulative total of 244 ANDA approvals from USFDA.

Company Overview

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products worldwide. Alembic’s state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The company is one of the leaders in branded generics in India, with its brands well recognized by doctors and patients.

Future Prospects

With this approval, Alembic Pharmaceuticals Limited continues to expand its generic drug portfolio, reinforcing its position in the pharmaceutical market. The company remains committed to delivering high-quality, affordable medications to patients globally. For more information, visit www.alembicpharmaceuticals.com.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited belongs to the › sector. Here’s a quick read on where the business and the stock stand today.

APLLTD
Healthcare › Drug Manufacturers - Specialty & Generic
APPROACHING RESISTANCE
80
Fundamental
70
Technical
76
Overall

1W -3.17%
1M +3.22%
3M +2.82%
P/E: 23.7 Cap: Mid
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

Alembic rises 14.5% over three months, with buying pressure holding steady. Thin margins at 9.2% leave limited room for error — any demand softness or cost spike hits the bottom line hard. Revenue grows at 10.1% and profits at 25.4% CAGR. The market consistently rewards this kind of compounding. The stock holds at 28% of its 52-week range with RSI at 58. In other words, neither side has a clear edge right now. Revenue grows at 10.1% and profits at 25.4%, and the dividend yield stands at 1.56%. The business is in good shape. Moreover, a stock that does not move despite strong fundamentals often offers better value than one already priced for perfection. Check Fundamentals of Alembic Pharmaceuticals Limited.

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