SUPAC OF IMMEDIATE-RELEASE, MODIFIED- RELEASE AND SEMI-SOLID: A REGULATORY NOTE

  • Kalpesh C. Ashara
  • Vishal P. Mendapara
  • Nitin M. Mori
  • J. K. Badjatya
DOI https://doi.org/10.22270/ijdra.v2i3.142

Abstract

In today scenario, as per market demand there is definitely carry out an increment or decrease in production, this is called SUPAC. Different guidelines are provided for those different types of SUPAC in by different regulatory authority for manufacturing of product. Here SUPAC guidelines for USFDA are elaborated for production in this review article.

Keywords: SUPAC-Guideline for IR, MR, SS, SUPAC Regulations.

Downloads

Download data is not yet available.

References

1. Mendapara VP SN, Purohit PV, Sanghavi G, Ashara KC. SUPAC of Immediate Release Solid Oral Dosage Form-Eplerenone. Inventi Rapid: Pharm Tech. 2013;3:1-7.
2. Azeem S and Sharma S, et al. Immediate release drug delivery systems: a review. Int J Biopharm Toxicol Res. 2011;1(1):24-46.
3. Lawrance MJ. Monographs & Excipients. In: Convection USP, editor. US 2008.
4. Wiley-Liss inc. The American Pharmacists Association. J Pharm Sci. 2000; 97:1350-60.
5. Carstensen JT, Rhodes CT. Drug Stability: Principles and Practices. 3rd ed; 2006. p. 227-35.
6. Expert Consultation for 2nd Addendum to the 3rd Edn of the Guidelines for Drinking-water Quality. Geneva; 15-19 May 2006.
7. Wiley-Liss inc. The American Pharmacists Association. J Pharm Sci. 2000; 97:1350-60.
8. WHO drug information book, Malta, Vol 12, 3rd ed; 1998.
9. Ashara KC, Paun JS, Soniwala MM, Chavda JR and Badjatiya JK. Nanoparticulate drug delivery system: A novel approach, International Journal of Drug Regulatory Affairs. 2013; 1(2): 39-48.
10. Patel R, Patel KR, Patel NM. Supac guidance for immediate release solid oral dosage forms. Internationale Pharmaceutica Sciencia. 2012; 2(2):35-44.
Statistics
594 Views | 613 Downloads
How to Cite
1.
Ashara KC, Mendapara VP, Mori NM, Badjatya JK. SUPAC OF IMMEDIATE-RELEASE, MODIFIED- RELEASE AND SEMI-SOLID: A REGULATORY NOTE. Int J Drug Reg Affairs [Internet]. 2018Feb.13 [cited 2025Mar.20];2(3):52-1. Available from: https://www.ijdra.com/index.php/journal/article/view/142
Issue
Vol 2 No 3 (2014): VOLUME 2, ISSUE 3, 2014
Section
Review
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.

I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.

Download link for COPYRIGHT FORM