APLLTD
Alembic Pharmaceuticals Limited (aplltd) Secures USFDA Tentative Approval for Darolutamide Tablets, 300 Mg
Alembic Pharmaceuticals Limited (APLLTD) announced USFDA tentative approval for Darolutamide Tablets, 300 mg, with an estimated market size of US$ 3,155 million.
Alembic Pharmaceuticals Limited (APLLTD) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Darolutamide Tablets, 300 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nubeqa Tablets, 300 mg, of Bayer HealthCare Pharmaceuticals Inc. (Bayer). Darolutamide is an androgen receptor inhibitor indicated for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic castration-sensitive prostate cancer (mCSPC), and mCSPC in combination with docetaxel. The market size for Darolutamide Tablets, 300 mg, is estimated at US$ 3,155 million for the twelve months ending March 2026 according to IQVIA.
About Alembic Pharmaceuticals Limited
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. Alembic’s state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. With a cumulative total of 238 ANDA approvals from USFDA, Alembic is one of the leaders in branded generics in India.
Forward-Looking Statement
Alembic Pharmaceuticals remains committed to expanding its portfolio of high-quality generics and continues to explore opportunities to bring innovative therapies to patients worldwide. The tentative approval for Darolutamide Tablets, 300 mg, is a significant milestone in this endeavor.
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. The PEG stands at 6.32 — severely stretched. Any earnings miss could trigger a sharp de-rating. Thin margins at 8.7% leave limited room for error — any demand softness or cost spike hits the bottom line hard. Buyers show up with 1.6x the volume of sellers. Moreover, they dominated on 17 of recent sessions versus 13 for sellers — a healthy accumulation pattern. Revenue grows at 7.7% and the stock moves sideways over three months. Neither side makes a strong case. The next earnings print will likely break this stock out of its current range. 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.
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 Healthcare › Drug Manufacturers – Specialty & Generic sector. Here’s a quick read on where the business and the stock stand today.
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.
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.
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.
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.
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.
-
Basic Materials2 days agoBharat Coking Coal Limited (bharatcoal) Signs Mou to Boost Domestic Coking Coal Production
-
Consumer Cyclical3 days agoRbz Jewellers Limited (rbzjewel) Expands Retail Footprint with 10,000 Sq. Ft. Flagship Store in Surat
-
Consumer Cyclical3 days agoLemon Tree Hotels Limited (lemontree) Announces Signing of Lemon Tree Hotel, Patancheru
-
Software - Infrastructure2 days agoSeshaasai Technologies Secures Contract with Leading Public Sector Life Insurer
-
Consumer Cyclical2 days agoEasy Trip Planners Limited (easemytrip) Launches Emtev Electric Buses in Bhopal, Aims for 5,000 Annual Manufacturing
-
Industrials2 days agoKalpataru Projects International Limited (kpil) Announces Successful Listing of Linjemontage on Nasdaq Stockholm
-
Industrials2 days agoR R Kabel Limited (rrkabel) Acquires U M Cables’ Optical Fibre Cable Business
-
Industrials2 days agoKalpataru Projects International Limited Announces First Day of Trading in Linjemontage’s Shares on Nasdaq Stockholm
