Alkem Laboratories Ltd - Company Profile
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Business Description
Alkem Laboratories Ltd (Alkem) provides active pharmaceutical ingredients (APIs) products, nutraceuticals, generic and branded products, biologics & biosimilars in advanced dosage forms complying with cGMP requirements.
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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 665 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 Medicines Control Council (MCC) in South Africa. The company also invests in the biosimilars segment through its subsidiary Enzene Biosciences. In FY2025, the company spent INR5,620 million on its R&D activities, which as a percentage of revenue stood at 4.3%. As of March 2025, the company filed 185 cumulative Abbreviated New Drug Application (ANDA) and two new drug applications (NDA) with the US FDA and has approvals for 156 ANDAs, including 13 tentative approvals, two NDAs, and more than 1,100 product registrations in various international markets. 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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