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Emcure Pharmaceuticals Limited

FDA Regulatory Profile

Emcure Pharmaceuticals Limited has 0 FDA recalls, 23 inspections, 0 510(k) clearances and 2 compliance actions on record.

Latest inspection
May 15, 2026 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections23Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 15, 2026Ahmedabad, IndiaDrugsVoluntary Action Indicated (VAI)3014595023
Oct 10, 2025Surendranagar, IndiaDrugsNo Action Indicated (NAI)3022175565
Feb 25, 2025Pune, IndiaDrugsVoluntary Action Indicated (VAI)3005782879
Apr 5, 2024Ahmedabad, IndiaDrugsVoluntary Action Indicated (VAI)3014595023
Mar 31, 2023Pune, IndiaDrugsNo Action Indicated (NAI)3006643860
Jun 24, 2022Gandhinagar, IndiaDrugsNo Action Indicated (NAI)3016408148
Mar 17, 2020Ahmedabad, IndiaDrugsVoluntary Action Indicated (VAI)3014595023
Jan 24, 2020Pune, IndiaDrugsVoluntary Action Indicated (VAI)3005782879
Feb 20, 2019Pune, IndiaDrugsOfficial Action Indicated (OAI)3005151215
Oct 30, 2018Pune, IndiaDrugsNo Action Indicated (NAI)3005151215
Aug 17, 2017Pune, IndiaDrugsOfficial Action Indicated (OAI)3005151215
Mar 4, 2016Pune, IndiaDrugsVoluntary Action Indicated (VAI)3005782879
May 8, 2015Pune, IndiaDrugsNo Action Indicated (NAI)3004378927
Feb 4, 2015Pune, IndiaDrugsOfficial Action Indicated (OAI)3005151215
Apr 4, 2014Pune, IndiaDrugsVoluntary Action Indicated (VAI)3005782879
Feb 7, 2014Pune, IndiaDrugsVoluntary Action Indicated (VAI)3005151215
Apr 26, 2013Pune, IndiaDrugsVoluntary Action Indicated (VAI)3005151215
Sep 18, 2012Pune, IndiaDrugsVoluntary Action Indicated (VAI)3005151215
Jun 9, 2011Pune, IndiaDrugsVoluntary Action Indicated (VAI)3005782879
Nov 22, 2010Pune, IndiaDrugsVoluntary Action Indicated (VAI)3005151215

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3014595023Ahmedabad, India3May 15, 2026
FEI 3022175565Surendranagar, India1Oct 10, 2025
FEI 3005782879Pune, India6Feb 25, 2025
FEI 3006643860Pune, India1Mar 31, 2023
FEI 3016408148Gandhinagar, India1Jun 24, 2022
FEI 3005151215Pune, India10Feb 20, 2019
FEI 3004378927Pune, India1May 8, 2015

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.