Alkem Laboratories Ltd - Company Profile

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Alkem Laboratories Ltd: Segment Analysis

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Business Description

Alkem Laboratories Ltd (Alkem) provides active pharmaceutical ingredients (APIs), nutraceuticals, generic and branded products, biologics & biosimilars in advanced dosage forms complying with cGMP requirements. Its portfolio encompasses products in the therapeutic areas of CNS, dermatology, anti-infectives, pain and analgesics, anti-diabetic, gynecology, gastro-intestinal, cardiac, respiratory, vitamins, minerals, and nutrients. The company markets its products in more than 40 countries in Australia, Europe, Africa, Southeast Asia, and Latin America. Alkem operates 20 manufacturing facilities, of which 17 are located in India and one in the US, and three R&D centres. Alkem manufactures formulations including tablets, injectables, dry syrups, and capsules. The company has manufacturing facilities in Baddi, Sikkim, Daman, and Indore. In the US facilities, liquids, semisolids, nasal sprays, and solids are manufactured in California, and APIs in Missouri. Its key markets include the UK, Germany, Australia, the Philippines, Chile, the Middle East, East Africa, and Kazakhstan. As of March 31, 2025, the company had 29 subsidiaries. In FY2025, the company’s capital expenditure stood at INR6,756.2 million, which grew 160% YoY.

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R&D Overview

Alkem is committed to investing in Research and Development (R&D) to drive innovation and accelerate the launch of new products. The company's R&D activities focus on a strategic shift towards biosimilars and other complex molecules to align with evolving industry dynamics and opportunities. Alkem’s R&D team comprises over 595 scientists who strive to continuously develop new products with cutting-edge technology at its three R&D centers across India and the US. All the R&D centers are equipped with state-of-the-art infrastructure and have been accredited by international regulatory authorities namely WHO, the US Food and Drug Administration (FDA), the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the Brazil Agencia Nacional de Vigilancia Sanitaria (ANVISA), Australia Therapeutic Goods Administration (TGA) and the Medicines Control Council (MCC) in South Africa. The company also invests in the biosimilars segment through its subsidiary Enzene Biosciences. In FY2026, the company spent INR6,173 million on its R&D activities, which, as a percentage of revenue, stood at 4.1%. As of March 2026, the company offers more than 800 brands and over 1500Stock Keeping Units. As of March 2026, the company filed 192 cumulative Abbreviated New Drug Applications (ANDAs) and two New Drug Applications (NDA) with the US FDA and has approvals for 148 ANDAs, including 13 tentative approvals, two NDAs, and more than 1,100 product registrations in various international markets. As of March 2026, the company has 6 granted patents and 55 pending patent applications. The company's clinical research facility is currently focused on bioequivalence and bioavailability studies aimed at proving the bioequivalence of dosage forms. Alkem is developing innovative products in collaboration with academia and research organizations like Harvard, Johns Hopkins University, NIH (USA), Syracuse University, Biosergen (Sweden), and others.




Geographical Segments

Performance

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Performance

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Performance

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