The Indian Pharmaceutical Landscape in 2025: CDSCO-Approved Small Molecules and Synthetic Approaches

In 2025, the Central Drugs Standard Control Organization (CDSCO) strengthened India’s pharmaceutical regulatory landscape through selective approval of novel drugs and intensified quality surveillance. Key approvals included tafamidis (amyloidosis), letermovir (post-transplant prophylaxis) and fexuprazan (erosive esophagitis). Concurrently, CDSCO flagged over 145 selected batches of drugs for failing quality standards, reflecting stricter enforcement of the New Drugs and Clinical Trials Rules (2019). This review discusses 20 small-molecule (<1000 Da) drugs approved in 2025 (from January to October) and the synthetic pathway for each therapeutic agent. Also, small molecules approved in the two previous years will be discussed. Peptides, radiopharmaceuticals, biologics, and inorganic compounds were excluded from the analysis. The review also highlights the most common impurities arising from the synthetic routes described and provides a comparative assessment of each drug against its main market competitors.