Indian regulatory requirements

DOI: https://doi.org/10.70593/978-93-49307-31-5_5

Authors

Anurag R. Panade
Department of Pharmaceutics, Ashokrao Mane College of Pharmacy, Peth-Vadgaon, Kolhapur, 416 112, India
Varda S. Joshi
Department of Pharmaceutics, Ashokrao Mane College of Pharmacy, Peth-Vadgaon, Kolhapur, 416 112, India
https://orcid.org/0009-0009-2900-8632
Sachin S. Mali
Department of Pharmaceutics, Bharati Vidyapeeth college of Pharmacy, Kolhapur 416 013, India
https://orcid.org/0000-0002-8104-5854
Pratik P. Kudale
Department of Pharmaceutics, Ashokrao Mane College of Pharmacy, Peth-Vadgaon, Kolhapur, 416 112, India

Synopsis

Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.
Keywords: Automation, Optimization, Process Control, Quality Assurance, Standardization validation.

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Volume

Technology and Quality in Industrial Pharmacy: Theory and Practice in Pharmaceutical Sciences

Pages

119-157

Published

February 5, 2025

Categories

Copyright (c) 2025 Varda S. Joshi; Anurag R. Panade, Abhishek R. Veer, Ruturaj T. Pawar, Sandip A. Bandgar, Riya R. Patil, Dhanashree R. Davare, Prajakta R. Patil; Sachin S. Mali, Durgacharan A. Bhagwat, Pavan V. Chavan; Pratik P. Kudale

How to Cite

Panade, A. R. ., Joshi, V. S., Mali, S. S. ., & Kudale, P. P. . (2025). Indian regulatory requirements. In V. S. Joshi, S. S. . Mali, D. A. . Bhagwat, & P. V. . Chavan (Eds.), Technology and Quality in Industrial Pharmacy: Theory and Practice in Pharmaceutical Sciences (pp. 119-157). Deep Science Publishing. https://doi.org/10.70593/978-93-49307-31-5_5
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