Shaivee Gautam, Abhay Kumar Gupta*, Satakshi Katiyar, Satyendra Mishra, Sonia Pandey and Divya Dwivedi

Faculty of Pharmaceutical Sciences, Rama University, Mandhana, Kanpur, Uttar Pradesh, India

*Corresponding Author: Abhay Kumar Gupta, Faculty of Pharmaceutical Sciences, Rama University, Mandhana, Kanpur, Uttar Pradesh, India.

Received: November 27, 2023; Published: December 11, 2023

Abstract

The formulation and development of pharmaceutical dosage forms are critical stages in the path from medication discovery to market availability. This study focuses on the manufacturing and approval processes related with the development of a new pharmaceutical dosage form. It explores into the complexities of production, quality control, and regulatory compliance to assure the safe and effective distribution of a medicine to patients. The investigation begins with the selection of an active pharmaceutical ingredient (API) and the optimization of its formulation to suit therapeutic criteria. Following that, the emphasis moves to translating this formulation into a scalable production method. To establish a repeatable, cost-effective, and high-quality dosage form, several production processes such as granulation, extrusion, and tableting are investigated. Throughout the production process, stringent quality control methods are undertaken to ensure uniformity in drug content, dissolving rates, and physical features. These actions are critical for meeting severe regulatory criteria and obtaining regulatory clearances. The study further highlights the importance of regulatory affairs in the pharmaceutical business. It goes on regulatory processes, current Good Manufacturing Practices (cGMP), and preparing dossiers for submission to regulatory agencies. The fact that these authorities approved the designed dosage form attests to its safety, effectiveness, and quality. Ultimately, this study emphasizes the need of thorough planning and execution in the pharmaceutical dosage form formulation, production, and approval procedures. A complete understanding of these processes is required to bring novel and safe drug delivery systems to market, eventually helping patients and improving the pharmaceutical sector.

Keywords: Investigation; API; Regulatory Compliance; Clearances; cGMP; Emphasizes; Novel

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Citation

Citation: Abhay Kumar Gupta., et al. “Study on Formulation and Development with New Drug Application and Investigational New Drug Application Process".Acta Scientific Pharmaceutical Sciences 8.1 (2024): 35-51.

Copyright

Copyright: © 2024 Abhay Kumar Gupta., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.