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.

Alembic Pharmaceuticals Limited (Alembic) announced today that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%. This marks a significant milestone for the company, as the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Ciprodex Otic Suspension, 0.3% / 0.1%, of Sandoz Inc. This approval will enable Alembic to offer an affordable treatment option for infections caused by susceptible microorganisms in both acute otitis media and acute otitis externa.

Market Potential

According to IQVIA, the estimated market size for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%, was US$110 million for twelve months ending June 2026. This approval further strengthens Alembic’s position in the generic pharmaceutical market, showcasing its capability to bring high-quality, cost-effective medications to patients.

Company Overview

Alembic Pharmaceuticals Limited, headquartered in India, has been at the forefront of healthcare since 1907. As a vertically integrated research and development pharmaceutical company, Alembic manufactures and markets generic pharmaceutical products globally. With state-of-the-art research and manufacturing facilities approved by regulatory authorities in many developed countries, including the USFDA, Alembic continues to lead in branded generics in India.

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.

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.