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# Zydus Petition on Indocin Suppositories
- URL: https://www.fdaweb.com/zydus-petition-on-indocin-suppositories/
- Published: 2023-09-14T12:00:00.000Z
- Updated: 2026-09-14T18:56:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155336

Zydus Pharmaceuticals submitted a 9/14 petition asking FDA to take certain actions concerning Indocin (indomethacin) suppositories, 50 mg, and its generic equivalent. The [petition](https://downloads.regulations.gov/FDA-2023-P-3944-0001/attachment%5F1.pdf?ref=fdaweb.com) says the International Conference on Harmonization (ICH) standards and established drug product impurity acceptance criteria should be followed by ANDA sponsors and applicants, given the risks associated with impurities exceeding established limits and the therapeutic utility of indomethacin suppositories.

The petition specifically asks that FDA take the following steps considering the risks presented by a high amount of unknown organic impurities in indomethacin suppositories:

- ensure that the currently marketed Indocin suppositories SR for indomethacin suppositories, 50 mg, approved under ANDA 073314 comply with ICH guidelines and established impurity acceptance criteria; and
- ensure compliance as per ICH guideline and established impurity acceptance criteria before approving any ANDA for indomethacin suppositories, 50 mg, which only justifies any higher impurity levels citing the results of the currently marketed Indocin suppositories SR without providing any adequate scientific justification for any higher impurities levels.