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Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations

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Abstract

Since the awareness of adverse effects associated with pharmaceutical excipients in drug formulations, these excipients are no longer considered inert substances. Numerous countries have recognized the potential risks that they pose to patients and have implemented diverse regulations to evaluate their safety, compatibility, toxicity, and quality. Regulatory authorities have proactively implemented measures to evaluate excipients and have formulated comprehensive guidelines that manufacturers are obligated to follow. This review primarily highlights the different provisions governing the utilization of excipients in drug formulation by regulatory authorities worldwide. Nonetheless, it is worth noting that there are still many countries that do not perceive excipients as posing a potential threat.

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Authors and Affiliations

  1. Department of Drug Regulatory Affairs, Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be University), Pune, Maharashtra, 411038, India

    Ashwin Mali, Vijaykumar Kuvar & Saily Bharadwaj

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  1. Ashwin Mali
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  2. Vijaykumar Kuvar
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  3. Saily Bharadwaj
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Correspondence to Ashwin Mali.

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Mali, A., Kuvar, V. & Bharadwaj, S. Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations. Ther Innov Regul Sci 58, 258–272 (2024). https://doi.org/10.1007/s43441-023-00597-z

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