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Glenmark Pharmaceuticals — USFDA Status

Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Glenmark Pharmaceuticals (NSE: GLENMARK, BSE: 532296), from US FDA records and exchange filings.

47
Compliance score (5 years) · how
5
USFDA-inspected plants on record
3
OAI classifications (5y)
1
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified VAI — 30 Jun 2026 (Colvale plant). Source: FDA Data Dashboard.
USFDA events by year
2022
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval

Plants

PlantFEILatest resultLast inspectionHistory (newest first)
Colvale
Glenmark Pharmaceuticals Limited
 3004672766 VAI 30 Jun 2026
Dhar
Glenmark Pharmaceuticals Limited
 3008565058 OAI 14 Feb 2025
Aurangabad
Glenmark Pharmaceuticals Limited
 3009915929 NAI 20 Sep 2024
Navi Mumbai
Glenmark Pharmaceuticals Ltd.
 3013139848 NAI 29 Sep 2023
Solan
Glenmark Pharmaceuticals Limited
 3005757050 OAI 22 Jun 2022

Full USFDA timeline

08 Sep 2026
US approval
USFDA tentative approval:
ANDA220307 —
Source: openFDA Drugs@FDA ↗
18 Aug 2026
US approval
USFDA approval: FLUTICASONE PROPIONATE
ANDA219232 — FLUTICASONE PROPIONATE
Source: openFDA Drugs@FDA ↗
09 Jul 2026
US approval
USFDA approval: NINTEDANIB ESYLATE
ANDA212555 — NINTEDANIB ESYLATE
Source: openFDA Drugs@FDA ↗
30 Jun 2026
VAI — minor issues
USFDA inspection classified VAI
Colvale · FEI 3004672766 · Glenmark Pharmaceuticals Limited, Colvale — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
08 Apr 2026
US approval
USFDA approval: PROGESTERONE
ANDA216363 — PROGESTERONE
Source: openFDA Drugs@FDA ↗
16 Mar 2026
US approval
USFDA approval: FLUTICASONE PROPIONATE
ANDA218742 — FLUTICASONE PROPIONATE
Source: openFDA Drugs@FDA ↗
03 Mar 2026
US approval
USFDA approval: FLUTICASONE PROPIONATE
ANDA219602 — FLUTICASONE PROPIONATE
Source: openFDA Drugs@FDA ↗
21 Jan 2026
US approval
USFDA approval: LACOSAMIDE
ANDA220268 — LACOSAMIDE
Source: openFDA Drugs@FDA ↗
05 Jan 2026
US approval
USFDA approval: SUCRALFATE
ANDA212141 — SUCRALFATE
Source: openFDA Drugs@FDA ↗
05 Aug 2025
US approval
USFDA approval: ERIBULIN MESYLATE
ANDA218142 — ERIBULIN MESYLATE
Source: openFDA Drugs@FDA ↗
21 Jul 2025
US approval
USFDA tentative approval:
ANDA213235 —
Source: openFDA Drugs@FDA ↗
28 Feb 2025
US approval
USFDA approval: OLOPATADINE HYDROCHLORIDE
ANDA219557 — OLOPATADINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
14 Feb 2025
OAI — serious issues
USFDA inspection classified OAI
Dhar · FEI 3008565058 · Glenmark Pharmaceuticals Limited, Dhar — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
20 Sep 2024
NAI — clean
USFDA inspection classified NAI
Aurangabad · FEI 3009915929 · Glenmark Pharmaceuticals Limited, Aurangabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
16 Jul 2024
US approval
USFDA approval: TOPIRAMATE
ANDA217869 — TOPIRAMATE
Source: openFDA Drugs@FDA ↗
11 Jun 2024
US approval
USFDA approval: ESOMEPRAZOLE MAGNESIUM
ANDA218092 — ESOMEPRAZOLE MAGNESIUM
Source: openFDA Drugs@FDA ↗
16 May 2024
US approval
USFDA approval: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
ANDA214987 — BRIMONIDINE TARTRATE, TIMOLOL MALEATE
Source: openFDA Drugs@FDA ↗
26 Apr 2024
US approval
USFDA approval: ACETAMINOPHEN AND IBUPROFEN
ANDA218311 — ACETAMINOPHEN, IBUPROFEN
Source: openFDA Drugs@FDA ↗
15 Dec 2023
NAI — clean
USFDA inspection classified NAI
Aurangabad · FEI 3009915929 · Glenmark Pharmaceuticals Limited, Aurangabad — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
29 Sep 2023
NAI — clean
USFDA inspection classified NAI
Navi Mumbai · FEI 3013139848 · Glenmark Pharmaceuticals Ltd., Navi Mumbai — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
25 Oct 2022
Import alert
Added to FDA import alert 66-40
Glenmark Pharmaceuticals Limited, Village Kishanpura, Baddi Nalagarh Road, Baddi, Solan, Himachal Pradesh INDIA
Source: FDA import alerts ↗
04 Aug 2022
NAI — clean
USFDA inspection classified NAI
Navi Mumbai · FEI 3013139848 · Glenmark Pharmaceuticals Ltd., Navi Mumbai — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
22 Jun 2022
Form 483
Form 483: 2 observations
Solan · FEI 3005757050 · Failure to meet specifications; input/output verification
Source: FDA Data Dashboard (citations) ↗
22 Jun 2022
OAI — serious issues
USFDA inspection classified OAI
Solan · FEI 3005757050 · Glenmark Pharmaceuticals Limited, Solan — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
20 May 2022
OAI — serious issues
USFDA inspection classified OAI
Colvale · FEI 3004672766 · Glenmark Pharmaceuticals Limited, Colvale — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
📎 Cite this data: Source: PharmaRoz analysis of FDA inspection data and exchange filings, updated 12 Nov 2026 — https://pharmaroz.com/company/glenmark