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Aurobindo Pharma — USFDA Status

Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Aurobindo Pharma (NSE: AUROPHARMA, BSE: 524804), from US FDA records and exchange filings.

38
Compliance score (5 years) · how
7
USFDA-inspected plants on record
5
OAI classifications (5y)
3
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: Form 483: 2 observations — 06 Feb 2026 (Sangareddy plant). Source: FDA Data Dashboard (citations).
USFDA events by year
2022
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval

Plants

PlantFEILatest resultLast inspectionHistory (newest first)
Sangareddy
Eugia Pharma Specialities Limited
 3008461619 OAI 06 Feb 2026
Riico Industrial Area
EUGIA Pharma Specialities Limited
 3009883410 OAI 14 Nov 2025
Medchal
Aurobindo Pharma Limited
 3004446312 OAI 05 Sep 2025
Sangareddy
Aurobindo Pharma Limited
 3004021263 VAI 29 Sep 2023
Medchal-Malkajgiri District
EUGIA Pharma Specialities Limited
 3011960448 NAI 26 Jul 2023
Medchal
Aurobindo Pharma Ltd
 3004021229 VAI 21 Jul 2023
Jedcherla Mandal, Mahabubnagar
Aurobindo Pharma Limited
 3007373532 VAI 10 May 2022

Full USFDA timeline

16 Oct 2026
US approval
USFDA approval: UPADACITINIB
ANDA218866 — UPADACITINIB
Source: openFDA Drugs@FDA ↗
06 Oct 2026
US approval
USFDA approval: SOLRIAMFETOL, SOLRIAMFETOL HYDROCHLORIDE
ANDA218725 — SOLRIAMFETOL, SOLRIAMFETOL HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
02 Oct 2026
US approval
USFDA approval: PERAMPANEL
ANDA220492 — PERAMPANEL
Source: openFDA Drugs@FDA ↗
02 Oct 2026
US approval
USFDA tentative approval:
ANDA219349 —
Source: openFDA Drugs@FDA ↗
25 Sep 2026
US approval
USFDA approval: METRONIDAZOLE
ANDA218485 — METRONIDAZOLE
Source: openFDA Drugs@FDA ↗
17 Sep 2026
US approval
USFDA approval: CYCLOSPORINE
ANDA219652 — CYCLOSPORINE
Source: openFDA Drugs@FDA ↗
14 Sep 2026
US approval
USFDA approval: BECLOMETHASONE DIPROPIONATE
ANDA214418 — BECLOMETHASONE DIPROPIONATE
Source: openFDA Drugs@FDA ↗
10 Sep 2026
US approval
USFDA approval: ISOTRETINOIN
ANDA220336 — ISOTRETINOIN
Source: openFDA Drugs@FDA ↗
02 Sep 2026
US approval
USFDA approval: SACUBITRIL AND VALSARTAN
ANDA213631 — SACUBITRIL, VALSARTAN
Source: openFDA Drugs@FDA ↗
11 Aug 2026
US approval
USFDA approval: TRIAMCINOLONE ACETONIDE
ANDA220110 — TRIAMCINOLONE ACETONIDE
Source: openFDA Drugs@FDA ↗
11 Aug 2026
US approval
USFDA tentative approval: CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ANDA213900 — CANAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
10 Aug 2026
US approval
USFDA approval: BRIVARACETAM
ANDA220288 — BRIVARACETAM
Source: openFDA Drugs@FDA ↗
07 Aug 2026
US approval
USFDA approval: VANCOMYCIN HYDROCHLORIDE
ANDA218130 — VANCOMYCIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
05 Aug 2026
US approval
USFDA approval: ESLICARBAZEPINE ACETATE
ANDA216481 — ESLICARBAZEPINE ACETATE
Source: openFDA Drugs@FDA ↗
22 Jul 2026
US approval
USFDA approval: ADAPALENE AND BENZOYL PEROXIDE
ANDA217384 — ADAPALENE, BENZOYL PEROXIDE
Source: openFDA Drugs@FDA ↗
21 Jul 2026
US approval
USFDA approval: BUPROPION HYDROCHLORIDE
ANDA216051 — BUPROPION HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
15 Jul 2026
US approval
USFDA approval: ETODOLAC
ANDA214872 — ETODOLAC
Source: openFDA Drugs@FDA ↗
24 Jun 2026
US approval
USFDA approval: ICOSAPENT ETHYL
ANDA218949 — ICOSAPENT ETHYL
Source: openFDA Drugs@FDA ↗
11 Jun 2026
US approval
USFDA tentative approval: EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ANDA212374 — EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
09 Jun 2026
US approval
USFDA approval: CEPHALEXIN
ANDA213568 — CEPHALEXIN
Source: openFDA Drugs@FDA ↗
03 Jun 2026
US approval
USFDA approval: TOFACITINIB CITRATE
ANDA215356 — TOFACITINIB CITRATE
Source: openFDA Drugs@FDA ↗
02 Jun 2026
US approval
USFDA approval: ELUXADOLINE
ANDA213511 — ELUXADOLINE
Source: openFDA Drugs@FDA ↗
21 May 2026
US approval
USFDA tentative approval: EMPAGLIFLOZIN
ANDA212371 — EMPAGLIFLOZIN
Source: openFDA Drugs@FDA ↗
28 Apr 2026
US approval
USFDA tentative approval: CENOBAMATE
ANDA219473 — CENOBAMATE
Source: openFDA Drugs@FDA ↗
20 Apr 2026
US approval
USFDA approval: PIRFENIDONE
ANDA212597 — PIRFENIDONE
Source: openFDA Drugs@FDA ↗
20 Apr 2026
US approval
USFDA approval: CANAGLIFLOZIN
ANDA210386 — CANAGLIFLOZIN
Source: openFDA Drugs@FDA ↗
15 Apr 2026
US approval
USFDA approval: GLYCEROL PHENYLBUTYRATE
ANDA220313 — GLYCEROL PHENYLBUTYRATE
Source: openFDA Drugs@FDA ↗
15 Apr 2026
US approval
USFDA approval: DEXTROMETHORPHAN POLISTIREX
ANDA218417 — DEXTROMETHORPHAN POLISTIREX
Source: openFDA Drugs@FDA ↗
06 Apr 2026
US approval
USFDA approval: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ANDA211489 — DAPAGLIFLOZIN, DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
06 Apr 2026
US approval
USFDA approval: DAPAGLIFLOZIN
ANDA211468 — DAPAGLIFLOZIN
Source: openFDA Drugs@FDA ↗
23 Mar 2026
US approval
USFDA approval: CEFIXIME
ANDA217607 — CEFIXIME
Source: openFDA Drugs@FDA ↗
18 Mar 2026
US approval
USFDA approval: CLINDAMYCIN PHOSPHATE
ANDA218942 — CLINDAMYCIN PHOSPHATE
Source: openFDA Drugs@FDA ↗
13 Mar 2026
US approval
USFDA approval: CITALOPRAM HYDROBROMIDE
ANDA219985 — CITALOPRAM HYDROBROMIDE
Source: openFDA Drugs@FDA ↗
06 Mar 2026
US approval
USFDA approval: SIPONIMOD
ANDA218459 — SIPONIMOD
Source: openFDA Drugs@FDA ↗
25 Feb 2026
US approval
USFDA approval: EVEROLIMUS
ANDA219533 — EVEROLIMUS
Source: openFDA Drugs@FDA ↗
24 Feb 2026
US approval
USFDA tentative approval: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA214859 — SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
18 Feb 2026
US approval
USFDA approval: ARIPIPRAZOLE
ANDA216208 — ARIPIPRAZOLE
Source: openFDA Drugs@FDA ↗
10 Feb 2026
US approval
USFDA tentative approval:
ANDA217786 —
Source: openFDA Drugs@FDA ↗
06 Feb 2026
Form 483
Form 483: 2 observations
Sangareddy · FEI 3008461619 · Second person sign off; Sterility/pyrogens - test methods written, followed
Source: FDA Data Dashboard (citations) ↗
06 Feb 2026
OAI — serious issues
USFDA inspection classified OAI
Sangareddy · FEI 3008461619 · Eugia Pharma Specialities Limited, Sangareddy — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
04 Feb 2026
US approval
USFDA tentative approval: NINTEDANIB
ANDA215123 — NINTEDANIB
Source: openFDA Drugs@FDA ↗
27 Jan 2026
US approval
USFDA approval: MESNA
ANDA220518 — MESNA
Source: openFDA Drugs@FDA ↗
26 Jan 2026
US approval
USFDA approval: BETAMETHASONE DIPROPIONATE
ANDA219348 — BETAMETHASONE DIPROPIONATE
Source: openFDA Drugs@FDA ↗
21 Jan 2026
US approval
USFDA approval: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ANDA217922 — BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE
Source: openFDA Drugs@FDA ↗
29 Dec 2025
US approval
USFDA approval: LOPERAMIDE HYDROCHLORIDE
ANDA220372 — LOPERAMIDE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
29 Dec 2025
US approval
USFDA approval: PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA218854 — PSEUDOEPHEDRINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
22 Dec 2025
US approval
USFDA tentative approval:
ANDA219328 —
Source: openFDA Drugs@FDA ↗
16 Dec 2025
US approval
USFDA approval: CARIPRAZINE HYDROCHLORIDE
ANDA213982 — CARIPRAZINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
20 Nov 2025
US approval
USFDA approval: POTASSIUM CHLORIDE
ANDA216536 — POTASSIUM CHLORIDE
Source: openFDA Drugs@FDA ↗
14 Nov 2025
US approval
USFDA approval: FOSFOMYCIN TROMETHAMINE
ANDA217608 — FOSFOMYCIN TROMETHAMINE
Source: openFDA Drugs@FDA ↗
14 Nov 2025
OAI — serious issues
USFDA inspection classified OAI
Riico Industrial Area · FEI 3009883410 · EUGIA Pharma Specialities Limited, Riico Industrial Area — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
03 Nov 2025
US approval
USFDA approval: LINAGLIPTIN
ANDA208415 — LINAGLIPTIN
Source: openFDA Drugs@FDA ↗
03 Oct 2025
US approval
USFDA approval: NAPROXEN
ANDA216504 — NAPROXEN
Source: openFDA Drugs@FDA ↗
08 Sep 2025
US approval
USFDA approval: PROCHLORPERAZINE MALEATE
ANDA218734 — PROCHLORPERAZINE MALEATE
Source: openFDA Drugs@FDA ↗
08 Sep 2025
US approval
USFDA approval: DEFERASIROX
ANDA215137 — DEFERASIROX
Source: openFDA Drugs@FDA ↗
05 Sep 2025
OAI — serious issues
USFDA inspection classified OAI
Medchal · FEI 3004446312 · Aurobindo Pharma Limited, Medchal — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
11 Aug 2025
US approval
USFDA approval: PIRFENIDONE
ANDA212596 — PIRFENIDONE
Source: openFDA Drugs@FDA ↗
29 Jul 2025
US approval
USFDA approval: LIDOCAINE HYDROCHLORIDE
ANDA219759 — LIDOCAINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
17 Jul 2025
US approval
USFDA approval: FUROSEMIDE
ANDA218831 — FUROSEMIDE
Source: openFDA Drugs@FDA ↗
09 Jul 2025
US approval
USFDA approval: FAMOTIDINE
ANDA219091 — FAMOTIDINE
Source: openFDA Drugs@FDA ↗
09 Jul 2025
US approval
USFDA approval: METRONIDAZOLE
ANDA219295 — METRONIDAZOLE
Source: openFDA Drugs@FDA ↗
30 Jun 2025
US approval
USFDA approval: IBUPROFEN AND FAMOTIDINE
ANDA219538 — FAMOTIDINE, IBUPROFEN
Source: openFDA Drugs@FDA ↗
09 Jun 2025
US approval
USFDA approval: SAPROPTERIN DIHYDROCHLORIDE
ANDA216797 — SAPROPTERIN DIHYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
30 May 2025
US approval
USFDA approval: ACETAZOLAMIDE
ANDA212089 — ACETAZOLAMIDE
Source: openFDA Drugs@FDA ↗
28 May 2025
US approval
USFDA tentative approval: UBROGEPANT
ANDA219088 — UBROGEPANT
Source: openFDA Drugs@FDA ↗
15 May 2025
US approval
USFDA approval: RIVAROXABAN
ANDA208544 — RIVAROXABAN
Source: openFDA Drugs@FDA ↗
14 May 2025
US approval
USFDA approval: DABIGATRAN ETEXILATE MESYLATE
ANDA208039 — DABIGATRAN ETEXILATE MESYLATE
Source: openFDA Drugs@FDA ↗
02 May 2025
US approval
USFDA approval: VARENICLINE TARTRATE
ANDA214595 — VARENICLINE TARTRATE
Source: openFDA Drugs@FDA ↗
30 Apr 2025
US approval
USFDA approval: OXCARBAZEPINE
ANDA219241 — OXCARBAZEPINE
Source: openFDA Drugs@FDA ↗
25 Apr 2025
US approval
USFDA approval: CHLORPROMAZINE HYDROCHLORIDE
ANDA216788 — CHLORPROMAZINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
22 Apr 2025
US approval
USFDA approval: DASATINIB
ANDA216547 — DASATINIB
Source: openFDA Drugs@FDA ↗
17 Apr 2025
US approval
USFDA approval: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA215232 — FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
15 Apr 2025
US approval
USFDA approval: ESOMEPRAZOLE MAGNESIUM
ANDA219213 — ESOMEPRAZOLE MAGNESIUM
Source: openFDA Drugs@FDA ↗
15 Apr 2025
US approval
USFDA approval: ESOMEPRAZOLE MAGNESIUM
ANDA218948 — ESOMEPRAZOLE MAGNESIUM
Source: openFDA Drugs@FDA ↗
14 Apr 2025
US approval
USFDA approval: ALLOPURINOL
ANDA215091 — ALLOPURINOL
Source: openFDA Drugs@FDA ↗
10 Apr 2025
US approval
USFDA approval: RIVAROXABAN
ANDA208544 — RIVAROXABAN
Source: openFDA Drugs@FDA ↗
04 Apr 2025
US approval
USFDA approval: DAPSONE
ANDA218457 — DAPSONE
Source: openFDA Drugs@FDA ↗
31 Mar 2025
US approval
USFDA approval: PANTOPRAZOLE SODIUM
ANDA217923 — PANTOPRAZOLE SODIUM
Source: openFDA Drugs@FDA ↗
26 Mar 2025
US approval
USFDA tentative approval: LUMATEPERONE
ANDA219085 — LUMATEPERONE
Source: openFDA Drugs@FDA ↗
21 Mar 2025
US approval
USFDA approval: NYSTATIN
ANDA219527 — NYSTATIN
Source: openFDA Drugs@FDA ↗
27 Feb 2025
US approval
USFDA approval: TRETINOIN
ANDA218245 — TRETINOIN
Source: openFDA Drugs@FDA ↗
12 Feb 2025
US approval
USFDA tentative approval:
ANDA216733 —
Source: openFDA Drugs@FDA ↗
11 Feb 2025
US approval
USFDA tentative approval:
ANDA212952 —
Source: openFDA Drugs@FDA ↗
27 Jan 2025
US approval
USFDA approval: AZELASTINE HYDROCHLORIDE ALLERGY
ANDA216561 — AZELASTINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
27 Jan 2025
US approval
USFDA tentative approval: AZELASTINE HYDROCHLORIDE ALLERGY
ANDA216561 — AZELASTINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
13 Jan 2025
US approval
USFDA approval: TRETINOIN
ANDA218246 — TRETINOIN
Source: openFDA Drugs@FDA ↗
31 Dec 2024
US approval
USFDA approval: GLYCOPYRROLATE
ANDA214847 — GLYCOPYRROLATE
Source: openFDA Drugs@FDA ↗
26 Dec 2024
US approval
USFDA approval: DEUTETRABENAZINE
ANDA215971 — DEUTETRABENAZINE
Source: openFDA Drugs@FDA ↗
12 Dec 2024
US approval
USFDA approval: CLOZAPINE
ANDA212923 — CLOZAPINE
Source: openFDA Drugs@FDA ↗
04 Dec 2024
US approval
USFDA approval: PAZOPANIB HYDROCHLORIDE
ANDA219034 — PAZOPANIB HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
22 Nov 2024
US approval
USFDA approval: MOMETASONE FUROATE
ANDA217498 — MOMETASONE FUROATE
Source: openFDA Drugs@FDA ↗
12 Nov 2024
US approval
USFDA approval: CIMETIDINE
ANDA218997 — CIMETIDINE
Source: openFDA Drugs@FDA ↗
30 Oct 2024
US approval
USFDA tentative approval:
ANDA217086 —
Source: openFDA Drugs@FDA ↗
18 Oct 2024
US approval
USFDA approval: METFORMIN HYDROCHLORIDE
ANDA209694 — METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
15 Oct 2024
US approval
USFDA approval: METRONIDAZOLE
ANDA218941 — METRONIDAZOLE
Source: openFDA Drugs@FDA ↗
27 Sep 2024
US approval
USFDA approval: CEPHALEXIN
ANDA218817 — CEPHALEXIN
Source: openFDA Drugs@FDA ↗
26 Sep 2024
US approval
USFDA approval: MYCOPHENOLATE MOFETIL
ANDA218227 — MYCOPHENOLATE MOFETIL
Source: openFDA Drugs@FDA ↗
23 Sep 2024
US approval
USFDA tentative approval:
ANDA210770 —
Source: openFDA Drugs@FDA ↗
02 Aug 2024
US approval
USFDA approval: ESTRADIOL
ANDA216550 — ESTRADIOL
Source: openFDA Drugs@FDA ↗
25 Jul 2024
US approval
USFDA approval: DOXEPIN HYDROCHLORIDE
ANDA216041 — DOXEPIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
22 Jul 2024
US approval
USFDA approval: BARICITINIB
ANDA217542 — BARICITINIB
Source: openFDA Drugs@FDA ↗
18 Jul 2024
US approval
USFDA approval: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
ANDA213300 — DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
18 Jul 2024
US approval
USFDA approval: POSACONAZOLE
ANDA217119 — POSACONAZOLE
Source: openFDA Drugs@FDA ↗
16 Jul 2024
US approval
USFDA approval: LEVOTHYROXINE SODIUM
ANDA216414 — LEVOTHYROXINE SODIUM
Source: openFDA Drugs@FDA ↗
25 Jun 2024
US approval
USFDA approval: BUSULFAN
ANDA215102 — BUSULFAN
Source: openFDA Drugs@FDA ↗
18 Jun 2024
US approval
USFDA approval: LIDOCAINE
ANDA217117 — LIDOCAINE
Source: openFDA Drugs@FDA ↗
03 Jun 2024
US approval
USFDA approval: TOFACITINIB CITRATE
ANDA218462 — TOFACITINIB CITRATE
Source: openFDA Drugs@FDA ↗
10 May 2024
US approval
USFDA approval: OSELTAMIVIR PHOSPHATE
ANDA218131 — OSELTAMIVIR PHOSPHATE
Source: openFDA Drugs@FDA ↗
10 May 2024
US approval
USFDA approval: FLUTICASONE PROPIONATE
ANDA217088 — FLUTICASONE PROPIONATE
Source: openFDA Drugs@FDA ↗
03 May 2024
OAI — serious issues
USFDA inspection classified OAI
Riico Industrial Area · FEI 3009883410 · EUGIA Pharma Specialities Limited, Riico Industrial Area — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
29 Apr 2024
US approval
USFDA approval: COLCHICINE
ANDA215463 — COLCHICINE
Source: openFDA Drugs@FDA ↗
22 Apr 2024
US approval
USFDA approval: MINOXIDIL (FOR MEN), MINOXIDIL (FOR WOMEN)
ANDA218616 — MINOXIDIL
Source: openFDA Drugs@FDA ↗
19 Apr 2024
US approval
USFDA approval: HALOPERIDOL
ANDA218789 — HALOPERIDOL
Source: openFDA Drugs@FDA ↗
10 Apr 2024
US approval
USFDA approval: BETAMETHASONE DIPROPIONATE
ANDA218289 — BETAMETHASONE DIPROPIONATE
Source: openFDA Drugs@FDA ↗
08 Apr 2024
US approval
USFDA approval: IBUPROFEN
ANDA213506 — IBUPROFEN
Source: openFDA Drugs@FDA ↗
26 Mar 2024
US approval
USFDA approval: ACETAMINOPHEN AND IBUPROFEN
ANDA218359 — ACETAMINOPHEN, IBUPROFEN
Source: openFDA Drugs@FDA ↗
21 Mar 2024
US approval
USFDA approval: DESMOPRESSIN ACETATE
ANDA213095 — DESMOPRESSIN ACETATE
Source: openFDA Drugs@FDA ↗
18 Mar 2024
US approval
USFDA approval: MOMETASONE FUROATE
ANDA215878 — MOMETASONE FUROATE
Source: openFDA Drugs@FDA ↗
14 Mar 2024
US approval
USFDA approval: SUNITINIB MALATE
ANDA218615 — SUNITINIB MALATE
Source: openFDA Drugs@FDA ↗
01 Mar 2024
US approval
USFDA approval: DOCOSANOL
ANDA217090 — DOCOSANOL
Source: openFDA Drugs@FDA ↗
28 Feb 2024
US approval
USFDA approval: FINGOLIMOD HYDROCHLORIDE
ANDA207983 — FINGOLIMOD HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
28 Feb 2024
US approval
USFDA approval: TESTOSTERONE ENANTHATE
ANDA212659 — TESTOSTERONE ENANTHATE
Source: openFDA Drugs@FDA ↗
27 Feb 2024
US approval
USFDA approval: MYCOPHENOLATE SODIUM
ANDA218603 — MYCOPHENOLATE SODIUM
Source: openFDA Drugs@FDA ↗
20 Feb 2024
US approval
USFDA approval: MYCOPHENOLATE MOFETIL
ANDA217937 — MYCOPHENOLATE MOFETIL
Source: openFDA Drugs@FDA ↗
13 Feb 2024
US approval
USFDA approval: ATORVASTATIN CALCIUM
ANDA217118 — ATORVASTATIN CALCIUM
Source: openFDA Drugs@FDA ↗
09 Feb 2024
US approval
USFDA approval: DEFLAZACORT
ANDA217123 — DEFLAZACORT
Source: openFDA Drugs@FDA ↗
02 Feb 2024
OAI — serious issues
USFDA inspection classified OAI
Sangareddy · FEI 3008461619 · Eugia Pharma Specialities Limited, Sangareddy — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
29 Jan 2024
US approval
USFDA approval: ISOTRETINOIN
ANDA218194 — ISOTRETINOIN
Source: openFDA Drugs@FDA ↗
24 Jan 2024
US approval
USFDA approval: LACOSAMIDE
ANDA209224 — LACOSAMIDE
Source: openFDA Drugs@FDA ↗
08 Jan 2024
US approval
USFDA approval: GENTAMICIN SULFATE
ANDA215237 — GENTAMICIN SULFATE
Source: openFDA Drugs@FDA ↗
08 Jan 2024
US approval
USFDA approval: GENTAMICIN SULFATE
ANDA215236 — GENTAMICIN SULFATE
Source: openFDA Drugs@FDA ↗
08 Jan 2024
US approval
USFDA approval: ENALAPRIL MALEATE
ANDA216458 — ENALAPRIL MALEATE
Source: openFDA Drugs@FDA ↗
05 Jan 2024
US approval
USFDA approval: MYCOPHENOLATE MOFETIL
ANDA217828 — MYCOPHENOLATE MOFETIL
Source: openFDA Drugs@FDA ↗
26 Dec 2023
US approval
USFDA approval: POSACONAZOLE
ANDA214842 — POSACONAZOLE
Source: openFDA Drugs@FDA ↗
14 Dec 2023
US approval
USFDA approval: DIAZEPAM
ANDA217843 — DIAZEPAM
Source: openFDA Drugs@FDA ↗
06 Dec 2023
US approval
USFDA approval: OSHIH
ANDA216558 — ETHINYL ESTRADIOL, NORETHINDRONE ACETATE
Source: openFDA Drugs@FDA ↗
29 Nov 2023
US approval
USFDA approval: BUDESONIDE
ANDA216667 — BUDESONIDE
Source: openFDA Drugs@FDA ↗
28 Nov 2023
US approval
USFDA approval: DARUNAVIR
ANDA210677 — DARUNAVIR
Source: openFDA Drugs@FDA ↗
27 Nov 2023
US approval
USFDA approval: ZAFIRLUKAST
ANDA213163 — ZAFIRLUKAST
Source: openFDA Drugs@FDA ↗
29 Sep 2023
VAI — minor issues
USFDA inspection classified VAI
Sangareddy · FEI 3004021263 · Aurobindo Pharma Limited, Sangareddy — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
26 Jul 2023
NAI — clean
USFDA inspection classified NAI
Medchal-Malkajgiri District · FEI 3011960448 · EUGIA Pharma Specialities Limited, Medchal-Malkajgiri District — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
21 Jul 2023
Form 483
Form 483: 1 observation
Medchal · FEI 3004021229 · Sanitation--buildings not clean, free of infestation
Source: FDA Data Dashboard (citations) ↗
21 Jul 2023
VAI — minor issues
USFDA inspection classified VAI
Medchal · FEI 3004021229 · Aurobindo Pharma Ltd, Medchal — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
09 Mar 2023
VAI — minor issues
USFDA inspection classified VAI
Medchal · FEI 3004446312 · Aurobindo Pharma Limited, Medchal — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
25 Nov 2022
VAI — minor issues
USFDA inspection classified VAI
Medchal-Malkajgiri District · FEI 3011960448 · EUGIA Pharma Specialities Limited, Medchal-Malkajgiri District — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
24 Jun 2022
VAI — minor issues
USFDA inspection classified VAI
Riico Industrial Area · FEI 3009883410 · EUGIA Pharma Specialities Limited, Riico Industrial Area — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
10 May 2022
Form 483
Form 483: 4 observations
Jedcherla Mandal, Mahabubnagar · FEI 3007373532 · Absence of Written Procedures; Computer control of master formula records; Extent of discrepancy, failure investigations; Prepared for each batch, include complete information
Source: FDA Data Dashboard (citations) ↗
10 May 2022
VAI — minor issues
USFDA inspection classified VAI
Jedcherla Mandal, Mahabubnagar · FEI 3007373532 · Aurobindo Pharma Limited, Jedcherla Mandal, Mahabubnagar — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
12 Jan 2022
Warning letter
USFDA warning letter
Aurobindo Pharmaceutical Limited — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (close-out issued)
Source: FDA warning letters ↗
📎 Cite this data: Source: PharmaRoz analysis of FDA inspection data and exchange filings, updated 12 Nov 2026 — https://pharmaroz.com/company/aurobindo