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Granules India — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Granules India (NSE: GRANULES, BSE: 532482), from US FDA records and exchange filings.
80
Compliance score (5 years) · how
4
USFDA-inspected plants on record
0
OAI classifications (5y)
0
Form 483s on record (5y)
1
Open warning letters
Latest USFDA record: USFDA inspection classified VAI — 20 Jun 2025 (Sangareddy District plant). Source: FDA Data Dashboard.
USFDA events by year
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Sangareddy District Granules India Limited |
3003723146 | VAI | 20 Jun 2025 | |
| Parawada Mandal Granules India Limited |
3012884557 | NAI | 12 Apr 2024 | |
| Visakhapatnam Granules India Limited |
3006583291 | NAI | 30 Jun 2023 | |
| Secunderabad Granules India Limited |
3001319869 | NAI | 23 Jun 2023 |
Full USFDA timeline
07 Jan 2026
US approval
USFDA tentative approval: AMPHETAMINE
ANDA220284 — AMPHETAMINE
Source: openFDA Drugs@FDA ↗
19 Dec 2025
US approval
USFDA tentative approval: AMPHETAMINE
ANDA219800 — AMPHETAMINE
Source: openFDA Drugs@FDA ↗
20 Jun 2025
VAI — minor issues
USFDA inspection classified VAI
Sangareddy District · FEI 3003723146 · Granules India Limited, Sangareddy District — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
26 Feb 2025
Warning letter
USFDA warning letter
Granules India Limited — CGMP/Finished Pharmaceuticals/Adulterated
Source: FDA warning letters ↗
12 Apr 2024
NAI — clean
USFDA inspection classified NAI
Parawada Mandal · FEI 3012884557 · Granules India Limited, Parawada Mandal — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
30 Jun 2023
NAI — clean
USFDA inspection classified NAI
Visakhapatnam · FEI 3006583291 · Granules India Limited, Visakhapatnam — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
23 Jun 2023
NAI — clean
USFDA inspection classified NAI
Secunderabad · FEI 3001319869 · Granules India Limited, Secunderabad — 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/granules