The Indian Pharmaceutical Landscape in 2025: CDSCO-Approved Small Molecules and Synthetic Approaches
- 1Department of Chemistry, Faculty of Science, University of Malta, MSD 2080 Msida, Malta
- 2Group of Catalysis and Organic Green Chemistry, Department of Pharmaceutical Sciences, University of Perugia, Via del Liceo 1, 06100 Perugia, Italy
Abstract
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.
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BibTeX
@article{tiz2026indian,
title = {{The Indian Pharmaceutical Landscape in 2025: CDSCO-Approved Small Molecules and Synthetic Approaches}},
author = {Davide Benedetto Tiz and Luana Bagnoli and Francesca Marini and David C. Magri and Luca Sancineto},
journal = {Molecules},
year = {2026},
month = nov,
doi = {10.3390/molecules31213962},
url = {https://www.mdpi.com/1420-3049/31/21/3962},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - The Indian Pharmaceutical Landscape in 2025: CDSCO-Approved Small Molecules and Synthetic Approaches
AU - Davide Benedetto Tiz
AU - Luana Bagnoli
AU - Francesca Marini
AU - David C. Magri
AU - Luca Sancineto
PY - 2026
DA - 2026/11/03
JO - Molecules
DO - 10.3390/molecules31213962
UR - https://www.mdpi.com/1420-3049/31/21/3962
AB - 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.
SN - 1420-3049
ER -