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Gland Pharma — USFDA Status

Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Gland Pharma (NSE: GLAND, BSE: 543245), from US FDA records and exchange filings.

75
Compliance score (5 years) · how
4
USFDA-inspected plants on record
0
OAI classifications (5y)
2
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified VAI — 25 Jul 2024 (Hyderabad 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)
Hyderabad
Gland Pharma Limited
 3002647489 VAI 25 Jul 2024
Parawada, Anakapalli
Gland Pharma Limited
 3010142300 NAI 24 May 2024
Sangareddy District, Hyderabad
Gland Pharma Limited
 3009864167 VAI 26 Aug 2023
Visakhapatnam
Gland Pharma Limited
 3009056604 NAI 28 Jul 2023

Full USFDA timeline

02 Mar 2026
US approval
USFDA tentative approval:
ANDA220091 —
Source: openFDA Drugs@FDA ↗
25 Jun 2025
US approval
USFDA tentative approval: ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
ANDA219632 — ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Source: openFDA Drugs@FDA ↗
05 Feb 2025
US approval
USFDA tentative approval:
ANDA216965 —
Source: openFDA Drugs@FDA ↗
30 Jan 2025
US approval
USFDA tentative approval:
ANDA216836 —
Source: openFDA Drugs@FDA ↗
25 Jul 2024
VAI — minor issues
USFDA inspection classified VAI
Hyderabad · FEI 3002647489 · Gland Pharma Limited, Hyderabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
24 May 2024
NAI — clean
USFDA inspection classified NAI
Parawada, Anakapalli · FEI 3010142300 · Gland Pharma Limited, Parawada, Anakapalli — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
05 Jan 2024
US approval
USFDA tentative approval: NETARSUDIL MESYLATE
ANDA216855 — NETARSUDIL
Source: openFDA Drugs@FDA ↗
26 Aug 2023
Form 483
Form 483: 1 observation
Sangareddy district, Hyderabad · FEI 3009864167 · Equipment Installation, Placement, Specified Requirements
Source: FDA Data Dashboard (citations) ↗
26 Aug 2023
VAI — minor issues
USFDA inspection classified VAI
Sangareddy district, Hyderabad · FEI 3009864167 · Gland Pharma Limited, Sangareddy district, Hyderabad — Compliance: Devices (Devices)
Source: FDA Data Dashboard ↗
28 Jul 2023
NAI — clean
USFDA inspection classified NAI
Visakhapatnam · FEI 3009056604 · Gland Pharma Limited, Visakhapatnam — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
14 Jul 2023
VAI — minor issues
USFDA inspection classified VAI
Hyderabad · FEI 3002647489 · Gland Pharma Limited, Hyderabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
27 Jun 2023
VAI — minor issues
USFDA inspection classified VAI
Sangareddy district, Hyderabad · FEI 3009864167 · Gland Pharma Limited, Sangareddy district, Hyderabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
27 Jan 2023
NAI — clean
USFDA inspection classified NAI
Parawada, Anakapalli · FEI 3010142300 · Gland Pharma Limited, Parawada, Anakapalli — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
25 Aug 2022
Form 483
Form 483: 1 observation
Hyderabad · FEI 3002647489 · Design control - no procedures
Source: FDA Data Dashboard (citations) ↗
25 Aug 2022
VAI — minor issues
USFDA inspection classified VAI
Hyderabad · FEI 3002647489 · Gland Pharma Limited, Hyderabad — Compliance: Devices (Devices)
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/gland