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Strides Pharma Science — USFDA Status

Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Strides Pharma Science (NSE: STAR, BSE: 532531), from US FDA records and exchange filings.

60
Compliance score (5 years) · how
3
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 — 20 May 2026 (Bangalore 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)
Bangalore
Strides Pharma Science Limited
 3004554612 VAI 20 May 2026
Chengalpattu
Strides Pharma Private Limited
 3005151016 VAI 05 Apr 2024
Puducherry
Strides Pharma Science Limited
 3012448465 VAI 24 Feb 2023

Full USFDA timeline

13 Oct 2026
US approval
USFDA approval: MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
ANDA208359 — DONEPEZIL HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
15 Sep 2026
US approval
USFDA approval: MILNACIPRAN HYDROCHLORIDE
ANDA207399 — MILNACIPRAN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
20 May 2026
VAI — minor issues
USFDA inspection classified VAI
Bangalore · FEI 3004554612 · Strides Pharma Science Limited, Bangalore — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
29 Apr 2025
US approval
USFDA approval: CELECOXIB
ANDA213127 — CELECOXIB
Source: openFDA Drugs@FDA ↗
28 Apr 2025
US approval
USFDA tentative approval:
ANDA216731 —
Source: openFDA Drugs@FDA ↗
17 Jan 2025
US approval
USFDA approval: ACETAMINOPHEN AND IBUPROFEN
ANDA217241 — ACETAMINOPHEN, IBUPROFEN
Source: openFDA Drugs@FDA ↗
13 Sep 2024
US approval
USFDA approval: FLUOXETINE HYDROCHLORIDE
ANDA212683 — FLUOXETINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
05 Sep 2024
US approval
USFDA approval: THEOPHYLLINE
ANDA215312 — THEOPHYLLINE
Source: openFDA Drugs@FDA ↗
21 May 2024
US approval
USFDA approval: SUCRALFATE
ANDA216474 — SUCRALFATE
Source: openFDA Drugs@FDA ↗
09 May 2024
US approval
USFDA approval: SEVELAMER CARBONATE
ANDA211915 — SEVELAMER CARBONATE
Source: openFDA Drugs@FDA ↗
05 Apr 2024
US approval
USFDA approval: FLUOXETINE HYDROCHLORIDE
ANDA212684 — FLUOXETINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
05 Apr 2024
Form 483
Form 483: 1 observation
Chengalpattu · FEI 3005151016 · Records not made readily available to FDA
Source: FDA Data Dashboard (citations) ↗
05 Apr 2024
VAI — minor issues
USFDA inspection classified VAI
Chengalpattu · FEI 3005151016 · Strides Pharma Private Limited, Chengalpattu — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
04 Mar 2024
US approval
USFDA approval: GABAPENTIN
ANDA211313 — GABAPENTIN
Source: openFDA Drugs@FDA ↗
24 Jan 2024
US approval
USFDA approval: PREGABALIN
ANDA209883 — PREGABALIN
Source: openFDA Drugs@FDA ↗
21 Dec 2023
US approval
USFDA approval: ATORVASTATIN CALCIUM
ANDA217634 — ATORVASTATIN CALCIUM
Source: openFDA Drugs@FDA ↗
22 Nov 2023
US approval
USFDA approval: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
ANDA215469 — MAGNESIUM SULFATE, POTASSIUM SULFATE, SODIUM SULFATE
Source: openFDA Drugs@FDA ↗
20 Nov 2023
US approval
USFDA approval: LEVETIRACETAM
ANDA214673 — LEVETIRACETAM
Source: openFDA Drugs@FDA ↗
24 Feb 2023
Form 483
Form 483: 1 observation
Puducherry · FEI 3012448465 · Complete instructions, procedures, specifications et. al.
Source: FDA Data Dashboard (citations) ↗
24 Feb 2023
VAI — minor issues
USFDA inspection classified VAI
Puducherry · FEI 3012448465 · Strides Pharma Science Limited, Puducherry — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
09 Dec 2022
VAI — minor issues
USFDA inspection classified VAI
Bangalore · FEI 3004554612 · Strides Pharma Science Limited, Bangalore — 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/strides