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 Healthcare › Drug Manufacturers – Specialty & Generic sector. Here’s a quick read on where the business and the stock stand today.

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.

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 Healthcare › Drug Manufacturers – Specialty & Generic sector. Here’s a quick read on where the business and the stock stand today.

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.

Alembic Pharmaceuticals Limited (APLLTD) announced today that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. This approval marks a significant milestone for the company as it expands its generic drug portfolio. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tamiflu Oral Suspension, 6 mg/mL, of Hoffmann-La Roche, Inc.

Market Potential

Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, is expected to capture a substantial market share with an estimated market size of US$ 27 million for the twelve months ending March 2026 according to IQVIA. This development underscores Alembic’s capability to deliver high-quality generic medications that meet global healthcare needs.

Company Overview

Alembic Pharmaceuticals Limited, headquartered in India, has been a leader in the healthcare sector since 1907. The company is vertically integrated with robust research and development capabilities. Alembic’s state-of-the-art facilities are approved by regulatory authorities worldwide, including the USFDA. With over 5500 employees, Alembic’s brands are well recognized by doctors and patients globally.

As a result of this approval, Alembic Pharmaceuticals Limited continues to strengthen its position in the generic pharmaceutical market, providing affordable and effective treatment options for patients. For further information, please contact Ajay Kumar Desai at +91 22-66953681 or via email at [email protected].

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited belongs to the Healthcare › Drug Manufacturers – Specialty & Generic sector. Here’s a quick read on where the business and the stock stand today.

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 29% 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 1.54%. 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.