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Lupin — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Lupin (NSE: LUPIN, BSE: 500257), from US FDA records and exchange filings.
64
Compliance score (5 years) · how
14
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 VAI — 21 Nov 2025 (Verna plant). Source: FDA Data Dashboard.
USFDA events by year
2021
2022
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Verna Lupin Limited |
3004819820 | VAI | 21 Nov 2025 | |
| Nagpur Lupin Limited |
3015392060 | VAI | 16 Sep 2025 | |
| Pithampur Lupin Limited |
3007549629 | OAI | 17 Jul 2025 | |
| Pithampur Lupin Limited |
3009107538 | VAI | 17 Jul 2025 | |
| Pithampur Lupin Limited |
3009831799 | VAI | 27 Sep 2024 | |
| Vadodara LUPIN MANUFACTURING SOLUTIONS LIMITED |
3005906909 | NAI | 12 Apr 2024 | |
| Aurangabad Lupin Ltd. |
3004995645 | VAI | 15 Mar 2024 | |
| Mandideep Lupin Limited (Unit II) |
3007756473 | NAI | 11 Aug 2023 | |
| Nagpur Lupin Limited |
3009843207 | VAI | 11 Jul 2023 | |
| Navi Mumbai LUPIN LIMITED |
3012681202 | NAI | 24 Mar 2023 | |
| Anakapalli District Lupin Manufacturing Solutions Limited |
3013127166 | NAI | 10 Mar 2023 | |
| Pune Lupin Bioresearch Center |
3008355456 | NAI | 09 Mar 2023 | |
| Mandideep Lupin Limited |
3002807511 | OAI | 23 Nov 2022 | |
| Tarapur, Thane Lupin Limited |
3002807512 | OAI | 04 Apr 2022 |
Full USFDA timeline
30 Sep 2026
25 Sep 2026
US approval
USFDA tentative approval: APIXABAN
NDA220446 — APIXABAN (Type 3 - New Dosage Form)
Source: openFDA Drugs@FDA ↗
03 Sep 2026
14 Aug 2026
US approval
USFDA approval: PITOLISANT HYDROCHLORIDE
ANDA218846 — PITOLISANT HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
07 Aug 2026
US approval
USFDA approval: SODIUM ZIRCONIUM CYCLOSILICATE
ANDA217549 — SODIUM ZIRCONIUM CYCLOSILICATE
Source: openFDA Drugs@FDA ↗
28 Jul 2026
US approval
USFDA approval: SUGAMMADEX SODIUM
ANDA214338 — SUGAMMADEX SODIUM
Source: openFDA Drugs@FDA ↗
27 Jul 2026
02 Jun 2026
US approval
USFDA approval: RANLUSPEC
BLA761480 — RANIBIZUMAB-HKDZ (Type 2 - New Active Ingredient)
Source: openFDA Drugs@FDA ↗
28 May 2026
US approval
USFDA approval: SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE
ANDA216095 — MAGNESIUM SULFATE, POTASSIUM CHLORIDE, SODIUM SULFATE
Source: openFDA Drugs@FDA ↗
15 May 2026
US approval
USFDA tentative approval: REVEFENACIN
ANDA218088 — REVEFENACIN
Source: openFDA Drugs@FDA ↗
12 May 2026
30 Apr 2026
US approval
USFDA approval: GLYCEROL PHENYLBUTYRATE
ANDA207694 — GLYCEROL PHENYLBUTYRATE
Source: openFDA Drugs@FDA ↗
06 Apr 2026
US approval
USFDA approval: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ANDA211579 — DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
06 Apr 2026
US approval
USFDA tentative approval: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ANDA211579 — DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
06 Apr 2026
23 Feb 2026
28 Nov 2025
21 Nov 2025
VAI — minor issues
USFDA inspection classified VAI
Verna · FEI 3004819820 · Lupin Limited, Verna — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
25 Sep 2025
16 Sep 2025
16 Sep 2025
VAI — minor issues
USFDA inspection classified VAI
Nagpur · FEI 3015392060 · Lupin Limited, Nagpur — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
25 Aug 2025
22 Jul 2025
22 Jul 2025
17 Jul 2025
Form 483
Form 483: 2 observations
Pithampur · FEI 3007549629 · Air Supply; Written in-process control procedures
Source: FDA Data Dashboard (citations) ↗
17 Jul 2025
OAI — serious issues
USFDA inspection classified OAI
Pithampur · FEI 3007549629 · Lupin Limited, Pithampur — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
17 Jul 2025
VAI — minor issues
USFDA inspection classified VAI
Pithampur · FEI 3009107538 · Lupin Limited, Pithampur — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
30 Jun 2025
US approval
USFDA approval: LOTEPREDNOL ETABONATE
ANDA218087 — LOTEPREDNOL ETABONATE
Source: openFDA Drugs@FDA ↗
24 Jun 2025
US approval
USFDA approval: PRUCALOPRIDE SUCCINATE
ANDA218847 — PRUCALOPRIDE SUCCINATE
Source: openFDA Drugs@FDA ↗
06 Jun 2025
US approval
USFDA tentative approval: OXCARBAZEPINE EXTENDED RELEASE TABLETS
ANDA219404 — OXCARBAZEPINE
Source: openFDA Drugs@FDA ↗
14 May 2025
06 May 2025
US approval
USFDA approval: RALTEGRAVIR POTASSIUM
ANDA217990 — RALTEGRAVIR POTASSIUM
Source: openFDA Drugs@FDA ↗
23 Apr 2025
12 Mar 2025
US approval
USFDA tentative approval: AMIFAMPRIDINE PHOSPHATE
ANDA217996 — AMIFAMPRIDINE PHOSPHATE
Source: openFDA Drugs@FDA ↗
03 Mar 2025
07 Feb 2025
US approval
USFDA approval: IPRATROPIUM BROMIDE
ANDA217912 — IPRATROPIUM BROMIDE
Source: openFDA Drugs@FDA ↗
28 Jan 2025
27 Jan 2025
US approval
USFDA approval: IPRATROPIUM BROMIDE
ANDA217886 — IPRATROPIUM BROMIDE
Source: openFDA Drugs@FDA ↗
08 Jan 2025
08 Jan 2025
US approval
USFDA approval: SACUBITRIL AND VALSARTAN
ANDA213808 — SACUBITRIL, VALSARTAN
Source: openFDA Drugs@FDA ↗
31 Dec 2024
13 Dec 2024
US approval
USFDA approval: EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE
ANDA213926 — EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE
Source: openFDA Drugs@FDA ↗
03 Dec 2024
US approval
USFDA tentative approval: ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE
ANDA218383 — ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE
Source: openFDA Drugs@FDA ↗
27 Nov 2024
07 Nov 2024
US approval
USFDA approval: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA214777 — AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE
Source: openFDA Drugs@FDA ↗
29 Oct 2024
US approval
USFDA tentative approval: DROSPIRENONE
ANDA216936 — DROSPIRENONE
Source: openFDA Drugs@FDA ↗
27 Sep 2024
VAI — minor issues
USFDA inspection classified VAI
Pithampur · FEI 3009831799 · Lupin Limited, Pithampur — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
17 Sep 2024
26 Aug 2024
US approval
USFDA approval: BRIMONIDINE TARTRATE
ANDA213215 — BRIMONIDINE TARTRATE
Source: openFDA Drugs@FDA ↗
13 Aug 2024
02 Aug 2024
US approval
USFDA approval: PREDNISOLONE ACETATE
ANDA216935 — PREDNISOLONE ACETATE
Source: openFDA Drugs@FDA ↗
29 Jul 2024
US approval
USFDA tentative approval: EMTRICITABINE; TENOFOVIR ALAFENAMIDE
ANDA215071 — EMTRICITABINE, TENOFOVIR ALAFENAMIDE
Source: openFDA Drugs@FDA ↗
16 Jul 2024
US approval
USFDA approval: DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
ANDA215178 — DOXORUBICIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
11 Jul 2024
08 Jul 2024
26 Jun 2024
13 Jun 2024
NAI — clean
USFDA inspection classified NAI
Nagpur · FEI 3015392060 · Lupin Limited, Nagpur — Compliance: Devices (Devices)
Source: FDA Data Dashboard ↗
31 May 2024
10 May 2024
03 May 2024
24 Apr 2024
US approval
USFDA approval: LOTEPREDNOL ETABONATE
ANDA215719 — LOTEPREDNOL ETABONATE
Source: openFDA Drugs@FDA ↗
12 Apr 2024
NAI — clean
USFDA inspection classified NAI
Vadodara · FEI 3005906909 · LUPIN MANUFACTURING SOLUTIONS LIMITED, Vadodara — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
08 Apr 2024
05 Apr 2024
US approval
USFDA tentative approval: VALBENAZINE TOSYLATE
ANDA216064 — VALBENAZINE TOSYLATE
Source: openFDA Drugs@FDA ↗
05 Apr 2024
US approval
USFDA approval: VALBENAZINE TOSYLATE
ANDA216064 — VALBENAZINE TOSYLATE
Source: openFDA Drugs@FDA ↗
28 Mar 2024
27 Mar 2024
US approval
USFDA approval: ESLICARBAZEPINE ACETATE
ANDA211246 — ESLICARBAZEPINE ACETATE
Source: openFDA Drugs@FDA ↗
18 Mar 2024
15 Mar 2024
VAI — minor issues
USFDA inspection classified VAI
Aurangabad · FEI 3004995645 · Lupin Ltd., Aurangabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
14 Mar 2024
US approval
USFDA approval: DOXYCYCLINE HYCLATE
ANDA217794 — DOXYCYCLINE HYCLATE
Source: openFDA Drugs@FDA ↗
15 Feb 2024
US approval
USFDA approval: MINZOYA
ANDA217087 — ETHINYL ESTRADIOL, LEVONORGESTREL
Source: openFDA Drugs@FDA ↗
02 Feb 2024
US approval
USFDA approval: BROMFENAC SODIUM
ANDA211239 — BROMFENAC SODIUM
Source: openFDA Drugs@FDA ↗
31 Jan 2024
US approval
USFDA approval: DRONEDARONE HYDROCHLORIDE
ANDA205904 — DRONEDARONE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
17 Jan 2024
12 Jan 2024
US approval
USFDA approval: PROPRANOLOL HYDROCHLORIDE
ANDA204349 — PROPRANOLOL HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
03 Jan 2024
US approval
USFDA tentative approval: DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE
ANDA211532 — DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE
Source: openFDA Drugs@FDA ↗
26 Dec 2023
US approval
USFDA approval: LOTEPREDNOL ETABONATE
ANDA215550 — LOTEPREDNOL ETABONATE
Source: openFDA Drugs@FDA ↗
14 Dec 2023
14 Dec 2023
04 Dec 2023
US approval
USFDA approval: VARENICLINE TARTRATE
ANDA211862 — VARENICLINE TARTRATE
Source: openFDA Drugs@FDA ↗
22 Nov 2023
22 Nov 2023
US approval
USFDA approval: BROMFENAC SODIUM
ANDA206027 — BROMFENAC SODIUM
Source: openFDA Drugs@FDA ↗
20 Nov 2023
US approval
USFDA approval: PITAVASTATIN CALCIUM
ANDA206029 — PITAVASTATIN CALCIUM
Source: openFDA Drugs@FDA ↗
16 Nov 2023
US approval
USFDA approval: GANIRELIX ACETATE
ANDA216075 — GANIRELIX ACETATE
Source: openFDA Drugs@FDA ↗
11 Aug 2023
NAI — clean
USFDA inspection classified NAI
Mandideep · FEI 3007756473 · Lupin Limited (Unit II), Mandideep — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
11 Jul 2023
Form 483
Form 483: 1 observation
Nagpur · FEI 3009843207 · Sample identification and other information
Source: FDA Data Dashboard (citations) ↗
11 Jul 2023
VAI — minor issues
USFDA inspection classified VAI
Nagpur · FEI 3009843207 · Lupin Limited, Nagpur — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
24 Mar 2023
NAI — clean
USFDA inspection classified NAI
Navi Mumbai · FEI 3012681202 · LUPIN LIMITED, Navi Mumbai — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
10 Mar 2023
NAI — clean
USFDA inspection classified NAI
Anakapalli District · FEI 3013127166 · Lupin Manufacturing Solutions Limited, Anakapalli District — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
09 Mar 2023
NAI — clean
USFDA inspection classified NAI
Pune · FEI 3008355456 · Lupin Bioresearch Center, Pune — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
23 Nov 2022
OAI — serious issues
USFDA inspection classified OAI
Mandideep · FEI 3002807511 · Lupin Limited, Mandideep — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
04 Apr 2022
OAI — serious issues
USFDA inspection classified OAI
Tarapur, Thane · FEI 3002807512 · Lupin Limited, Tarapur, Thane — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
18 Sep 2021
VAI — minor issues
USFDA inspection classified VAI
Verna · FEI 3004819820 · Lupin Limited, Verna — 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/lupin