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Glenmark Pharmaceuticals Limited

FDA Regulatory Profile

Glenmark Pharmaceuticals Limited has 0 FDA recalls, 32 inspections, 0 510(k) clearances and 3 compliance actions on record.

Latest inspection
Jun 30, 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
Inspections32Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions3Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 30, 2026Colvale, IndiaDrugsVoluntary Action Indicated (VAI)3004672766
Feb 14, 2025Dhar, IndiaDrugsOfficial Action Indicated (OAI)3008565058
Sep 20, 2024Aurangabad, IndiaDrugsNo Action Indicated (NAI)3009915929
Dec 15, 2023Aurangabad, IndiaDrugsNo Action Indicated (NAI)3009915929
Sep 29, 2023Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3013139848
Aug 4, 2022Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3013139848
Jun 22, 2022Solan, IndiaDrugsOfficial Action Indicated (OAI)3005757050
May 20, 2022Colvale, IndiaDrugsOfficial Action Indicated (OAI)3004672766
Feb 25, 2020Dhar, IndiaDrugsNo Action Indicated (NAI)3008565058
Feb 21, 2020Aurangabad, IndiaDrugsNo Action Indicated (NAI)3009915929
Jan 17, 2020Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3004109039
Sep 13, 2019Dhar, IndiaDrugsNo Action Indicated (NAI)3008565058
Jun 21, 2019Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3007086147
Jun 6, 2019Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3013139848
Mar 15, 2019Colvale, IndiaDrugsVoluntary Action Indicated (VAI)3004672766
Nov 13, 2018Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3004109039
Sep 21, 2018Solan, IndiaDrugsNo Action Indicated (NAI)3005757050
Aug 17, 2018Aurangabad, IndiaDrugsVoluntary Action Indicated (VAI)3009915929
May 24, 2018Dhar, IndiaDrugsVoluntary Action Indicated (VAI)3008565058
Nov 11, 2017Solan, IndiaDrugsVoluntary Action Indicated (VAI)3005757050

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 3004672766Colvale, India7Jun 30, 2026
FEI 3008565058Dhar, India8Feb 14, 2025
FEI 3009915929Aurangabad, India5Sep 20, 2024
FEI 3013139848Navi Mumbai, India3Sep 29, 2023
FEI 3005757050Solan, India6Jun 22, 2022
FEI 3004109039Navi Mumbai, India2Jan 17, 2020
FEI 3007086147Navi Mumbai, India1Jun 21, 2019

FDA data resources

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