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) Q2 FY27: Revenue Up 36%; PAT Surges 81% Yoy
Alembic Pharmaceuticals Limited (APLLTD) reports strong Q2 FY27 performance with revenue up 36% and PAT up 81% YoY.
Alembic Pharmaceuticals Limited (APLLTD) reported its consolidated financial results for the second quarter and half year ended 30th September, 2026. The company delivered another quarter of strong, broad-based growth and improved profitability, reflecting consistent execution across markets. Revenue from operations increased by 36% year-on-year to Rs. 2603 Cr. Moreover, the Profit After Tax (PAT) surged by 81% year-on-year to Rs. 335 Cr.
Operational Highlights
The India Branded Business delivered 14% year-on-year growth, reaching Rs 725 Cr. in revenue for the quarter. Gynecology, Cardiology, Gastrology, and Ophthalmology registered robust growth. Animal Health continued its growth momentum with 23% growth for the quarter.
International Business
US Formulations grew by 77% to Rs. 1003 Cr. The company also had three launches in the US market during the quarter. Ex-US grew by 12% to Rs. 440 Cr. The Active Pharmaceutical Ingredients (API) business grew by 39% to Rs. 436 Cr.
Commenting on the results, Mr. Pranav Amin, Managing Director, Alembic Pharmaceuticals Limited, said, “We delivered another quarter of strong, broad-based growth and improved profitability, reflecting consistent execution across markets. Following a strong first half, we are well positioned to sustain growth and create long-term value for all our stakeholders.”
For more information, visit www.alembicpharmaceuticals.com or contact Isha Lamba at +91 022-66951652 or [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 8.9% 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 1.5x the volume of sellers. Moreover, they dominated on 17 of recent sessions versus 13 for sellers — a healthy accumulation pattern. 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 (aplltd) Receives USFDA Final Approval for Venetoclax Tablets
Alembic Pharmaceuticals Limited (APLLTD) secures USFDA final approval for Venetoclax Tablets, 10 mg, 50 mg, and 100 mg, expanding its generic drug portfolio.
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) for Venetoclax Tablets, 10 mg, 50 mg, and 100 mg. This approval marks a significant milestone for Alembic, as the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Venclexta Tablets, of AbbVie Inc. Venetoclax tablets are indicated for treating adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and, in combination with other drugs, for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older or those with comorbidities. With this approval, Alembic may be eligible for 180 days of generic drug exclusivity. According to IQVIA, the market size for Venetoclax tablets was estimated at US $1,584 million in the United States for the twelve months ending June 2026. This approval adds to Alembic’s cumulative total of 248 ANDA approvals from the USFDA, reinforcing its position as a leader in branded generics in India.
Significance of the Approval
The USFDA approval for Venetoclax tablets is a testament to Alembic’s commitment to providing affordable and effective treatment options for various cancers. Venetoclax has shown significant efficacy in treating chronic lymphocytic leukemia and acute myeloid leukemia, offering hope to numerous patients. This approval not only expands Alembic’s generic drug portfolio but also underscores the company’s capability to deliver high-quality, cost-effective medications to the US market.
Company’s Position in the Generic Drug Market
Alembic Pharmaceuticals Limited, established in 1907, has been at the forefront of healthcare innovation. The company’s vertically integrated research and development model has enabled it to manufacture and market a wide range of generic pharmaceutical products globally. With state-of-the-art research and manufacturing facilities approved by regulatory authorities worldwide, Alembic continues to lead in the branded generics sector in India. The recent approval for Venetoclax tablets is a significant addition to its extensive list of ANDA approvals, reflecting the company’s robust pipeline and strategic growth in the generic drug market.
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 8.9% 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 1.5x the volume of sellers. Moreover, they dominated on 17 of recent sessions versus 13 for sellers — a healthy accumulation pattern. 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 (aplltd) Receives USFDA Final Approval for Valganciclovir for Oral Solution
Alembic Pharmaceuticals Limited (APLLTD) secures USFDA final approval for Valganciclovir for Oral Solution, 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) for Valganciclovir for Oral Solution, 50 mg/mL. This approval marks a significant milestone for Alembic as it continues to expand its generic drug portfolio. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Valcyte for Oral Solution 50 mg/mL of CHEPLAPHARM Arzneimittel GmbH (CHEPLAPHARM).
Valganciclovir for Oral Solution Indications
Valganciclovir for oral solution is indicated for: 1) treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS), and 2) prevention of CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk. Refer to the label for a detailed indication and usage.
Company’s Approval Milestone
With this approval, Alembic Pharmaceuticals Limited has now secured a cumulative total of 247 ANDA approvals (227 final approvals and 20 tentative approvals) from the USFDA. This achievement underscores Alembic’s commitment to providing high-quality, affordable generic pharmaceutical products to meet global healthcare needs.
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. The company’s state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.
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 8.9% 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 1.5x the volume of sellers. Moreover, they dominated on 17 of recent sessions versus 13 for sellers — a healthy accumulation pattern. 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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