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Sun Pharmaceutical Industries — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Sun Pharmaceutical Industries (NSE: SUNPHARMA, BSE: 524715), from US FDA records and exchange filings.
37
Compliance score (5 years) · how
10
USFDA-inspected plants on record
3
OAI classifications (5y)
2
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified NAI — 11 Sep 2026 (Ahmednagar plant). Source: FDA Data Dashboard.
USFDA events by year
2009
2014
2022
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Ahmednagar Sun Pharmaceutical Industries Limited |
3003227153 | NAI | 11 Sep 2026 | |
| Gurugram Sun Pharmaceutical Industries Limited |
3002871444 | NAI | 31 Jul 2026 | |
| Vadodara Sun Pharmaceutical Industries Ltd |
3004520113 | NAI | 24 Jul 2026 | |
| Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam |
3007627683 | NAI | 18 Jul 2025 | |
| Halol Sun Pharmaceutical Industries Ltd. |
3002809586 | OAI | 13 Jun 2025 | |
| Panoli Sun Pharmaceutical Industries Ltd. |
3003952717 | NAI | 13 Jun 2025 | |
| Bharuch Sun Pharmaceutical Industries Ltd |
3010027135 | VAI | 17 May 2024 | |
| Halol Sun Pharmaceutical Medicare Limited |
3002957541 | NAI | 27 Feb 2024 | |
| New Delhi Sun Pharmaceutical Industries Limited |
3003892973 | VAI | 17 Mar 2023 | |
| Mohali Sun Pharmaceutical Industries Limited |
3002807979 | OAI | 12 Aug 2022 |
Full USFDA timeline
11 Sep 2026
NAI — clean
USFDA inspection classified NAI
Ahmednagar · FEI 3003227153 · Sun Pharmaceutical Industries Limited, Ahmednagar — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
31 Jul 2026
NAI — clean
USFDA inspection classified NAI
Gurugram · FEI 3002871444 · Sun Pharmaceutical Industries Limited, Gurugram — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
24 Jul 2026
NAI — clean
USFDA inspection classified NAI
Vadodara · FEI 3004520113 · Sun Pharmaceutical Industries Ltd, Vadodara — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
28 Apr 2026
US approval
USFDA approval: DOXEPIN HYDROCHLORIDE
ANDA213919 — DOXEPIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
06 Feb 2026
VAI — minor issues
USFDA inspection classified VAI
Vadodara · FEI 3004520113 · Sun Pharmaceutical Industries Ltd, Vadodara — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
18 Jul 2025
NAI — clean
USFDA inspection classified NAI
Kanchipuram · FEI 3007627683 · Sun Pharmaceutical Industries Limited- Madhuranthagam, Kanchipuram — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
13 Jun 2025
NAI — clean
USFDA inspection classified NAI
Panoli · FEI 3003952717 · Sun Pharmaceutical Industries Ltd., Panoli — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
13 Jun 2025
OAI — serious issues
USFDA inspection classified OAI
Halol · FEI 3002809586 · Sun Pharmaceutical Industries Ltd., Halol — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
02 May 2025
US approval
USFDA approval: HALOBETASOL PROPIONATE AND TAZAROTENE
ANDA217190 — HALOBETASOL PROPIONATE, TAZAROTENE
Source: openFDA Drugs@FDA ↗
12 Jun 2024
17 May 2024
VAI — minor issues
USFDA inspection classified VAI
Bharuch · FEI 3010027135 · Sun Pharmaceutical Industries Ltd, Bharuch — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
27 Feb 2024
NAI — clean
USFDA inspection classified NAI
Halol · FEI 3002957541 · Sun Pharmaceutical Medicare Limited, Halol — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
07 Dec 2023
US approval
USFDA approval: LIDOCAINE HYDROCHLORIDE
ANDA218182 — LIDOCAINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
13 Jul 2023
VAI — minor issues
USFDA inspection classified VAI
Halol · FEI 3002957541 · Sun Pharmaceutical Medicare Limited, Halol — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
17 Mar 2023
VAI — minor issues
USFDA inspection classified VAI
New Delhi · FEI 3003892973 · Sun Pharmaceutical Industries Limited, New Delhi — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
17 Feb 2023
NAI — clean
USFDA inspection classified NAI
Kanchipuram · FEI 3007627683 · Sun Pharmaceutical Industries Limited- Madhuranthagam, Kanchipuram — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
07 Dec 2022
Import alert
Added to FDA import alert 66-40
Sun Pharmaceutical Industries Ltd., Halol - Baroda Highway, Halol, Gujarat INDIA
Source: FDA import alerts ↗
12 Aug 2022
Form 483
Form 483: 3 observations
Mohali · FEI 3002807979 · Approval and review of procedures; Complete Test Data; Written Procedures Not Followed
Source: FDA Data Dashboard (citations) ↗
12 Aug 2022
OAI — serious issues
USFDA inspection classified OAI
Mohali · FEI 3002807979 · Sun Pharmaceutical Industries Limited, Mohali — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
09 May 2022
Form 483
Form 483: 5 observations
Halol · FEI 3002809586 · Aseptic Processing Area; Cleaning / Sanitizing / Maintenance; Equipment Design, Size and Location; Scientifically sound laboratory controls; Written program not followed
Source: FDA Data Dashboard (citations) ↗
09 May 2022
OAI — serious issues
USFDA inspection classified OAI
Halol · FEI 3002809586 · Sun Pharmaceutical Industries Ltd., Halol — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
12 Mar 2014
Import alert
Added to FDA import alert 66-40
Sun Pharmaceutical Industries Limited - Karkhadi, A Plot No 817, Village Karkhadi, Padra, Gujarat INDIA
Source: FDA import alerts ↗
10 Sep 2009
Import alert
Added to FDA import alert 66-40
Sun Pharmaceutical Industries (prev. Ranbaxy), 3 Industrial Area, Dewas, Madhya Pradesh INDIA
Source: FDA import alerts ↗
10 Sep 2009
Import alert
Added to FDA import alert 66-40
Sun Pharmaceutical Industries (prev. Ranbaxy), Village Ganguwala, Tehsil-Paonta Sahib, Sirmaur, Himachal Pradesh INDIA
Source: FDA import alerts ↗
📎 Cite this data: Source: PharmaRoz analysis of FDA inspection data and exchange filings, updated 12 Nov 2026 — https://pharmaroz.com/company/sun-pharma