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Cipla — USFDA Status

Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Cipla (NSE: CIPLA, BSE: 500087), from US FDA records and exchange filings.

33
Compliance score (5 years) · how
6
USFDA-inspected plants on record
2
OAI classifications (5y)
1
Form 483s on record (5y)
1
Open warning letters
Latest USFDA record: USFDA inspection classified VAI — 30 May 2025 (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
Cipla Ltd.
 3005857289 VAI 30 May 2025
Bengaluru
Cipla Limited
 3002806691 VAI 13 Nov 2024
Salcette
Cipla Limited
 3004081307 VAI 21 Jun 2024
Kurkumbh Village, Dist. Pune
Cipla, Ltd.
 3002806702 VAI 08 May 2024
Raigad
Cipla Limited
 3002806710 VAI 04 Apr 2024
Pithampur, District Dhar
Cipla Limited
 3008581988 OAI 17 Feb 2023

Full USFDA timeline

16 Oct 2026
US approval
USFDA approval: CABOZANTINIB S-MALATE
ANDA217870 — CABOZANTINIB S-MALATE
Source: openFDA Drugs@FDA ↗
17 Sep 2026
US approval
USFDA approval: CALCIUM GLUCONATE IN SODIUM CHLORIDE
ANDA217891 — CALCIUM GLUCONATE
Source: openFDA Drugs@FDA ↗
31 Aug 2026
US approval
USFDA approval: POMALIDOMIDE
ANDA219718 — POMALIDOMIDE
Source: openFDA Drugs@FDA ↗
27 Jul 2026
US approval
USFDA approval: FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
ANDA213087 — FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE
Source: openFDA Drugs@FDA ↗
22 Apr 2026
US approval
USFDA approval: ALBUTEROL SULFATE
ANDA219409 — ALBUTEROL SULFATE
Source: openFDA Drugs@FDA ↗
06 Apr 2026
US approval
USFDA approval: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ANDA211595 — DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
06 Apr 2026
US approval
USFDA approval: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ANDA211536 — DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
06 Apr 2026
US approval
USFDA approval: DAPAGLIFLOZIN
ANDA211535 — DAPAGLIFLOZIN
Source: openFDA Drugs@FDA ↗
02 Apr 2026
US approval
USFDA approval: NINTEDANIB ESYLATE
ANDA212609 — NINTEDANIB ESYLATE
Source: openFDA Drugs@FDA ↗
16 Mar 2026
US approval
USFDA tentative approval: RIFAXIMIN
ANDA219570 — RIFAXIMIN
Source: openFDA Drugs@FDA ↗
25 Feb 2026
US approval
USFDA tentative approval: PALBOCICLIB
ANDA212980 — PALBOCICLIB
Source: openFDA Drugs@FDA ↗
02 Feb 2026
US approval
USFDA approval: LENALIDOMIDE
ANDA213165 — LENALIDOMIDE
Source: openFDA Drugs@FDA ↗
03 Nov 2025
US approval
USFDA tentative approval:
ANDA215897 —
Source: openFDA Drugs@FDA ↗
14 Oct 2025
US approval
USFDA tentative approval: BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
ANDA218766 — BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Source: openFDA Drugs@FDA ↗
10 Oct 2025
US approval
USFDA tentative approval: EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
ANDA211680 — EMTRICITABINE, TENOFOVIR ALAFENAMIDE
Source: openFDA Drugs@FDA ↗
15 Sep 2025
US approval
USFDA approval: GLUCAGON
ANDA218813 — GLUCAGON
Source: openFDA Drugs@FDA ↗
21 Jul 2025
US approval
USFDA approval: SELENIOUS ACID
ANDA218661 — SELENIOUS ACID
Source: openFDA Drugs@FDA ↗
30 Jun 2025
US approval
USFDA tentative approval: ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE
ANDA210391 — ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE
Source: openFDA Drugs@FDA ↗
24 Jun 2025
US approval
USFDA tentative approval: BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
ANDA216914 — BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Source: openFDA Drugs@FDA ↗
12 Jun 2025
US approval
USFDA tentative approval: DOLUTEGRAVIR SODIUM AND ABACAVIR SULFATE AND LAMIVUDINE
ANDA210811 — ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE
Source: openFDA Drugs@FDA ↗
02 Jun 2025
US approval
USFDA tentative approval: OLAPARIB
ANDA219410 — OLAPARIB
Source: openFDA Drugs@FDA ↗
30 May 2025
VAI — minor issues
USFDA inspection classified VAI
Bangalore · FEI 3005857289 · Cipla Ltd., Bangalore — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
16 May 2025
US approval
USFDA approval: GEFITINIB
ANDA211826 — GEFITINIB
Source: openFDA Drugs@FDA ↗
02 May 2025
US approval
USFDA approval: ACYCLOVIR
ANDA212981 — ACYCLOVIR
Source: openFDA Drugs@FDA ↗
10 Apr 2025
US approval
USFDA approval: PACLITAXEL
ANDA209657 — PACLITAXEL
Source: openFDA Drugs@FDA ↗
03 Apr 2025
US approval
USFDA tentative approval:
ANDA213495 —
Source: openFDA Drugs@FDA ↗
31 Mar 2025
US approval
USFDA approval: PANTOPRAZOLE SODIUM
ANDA217458 — PANTOPRAZOLE SODIUM
Source: openFDA Drugs@FDA ↗
13 Mar 2025
US approval
USFDA tentative approval:
NDA212205 — (Type 4 - New Combination)
Source: openFDA Drugs@FDA ↗
19 Feb 2025
US approval
USFDA approval: NILOTINIB D-TARTRATE
NDA218922 — NILOTINIB D-TARTRATE (Type 3 - New Dosage Form)
Source: openFDA Drugs@FDA ↗
24 Jan 2025
US approval
USFDA approval: POTASSIUM PHOSPHATES
ANDA217892 — POTASSIUM PHOSPHATE, DIBASIC, POTASSIUM PHOSPHATE, MONOBASIC
Source: openFDA Drugs@FDA ↗
10 Jan 2025
US approval
USFDA tentative approval: SIPONIMOD
ANDA218228 — SIPONIMOD
Source: openFDA Drugs@FDA ↗
07 Jan 2025
US approval
USFDA approval: ESOMEPRAZOLE MAGNESIUM
ANDA217714 — ESOMEPRAZOLE MAGNESIUM
Source: openFDA Drugs@FDA ↗
03 Jan 2025
US approval
USFDA approval: PHYTONADIONE
ANDA214966 — PHYTONADIONE
Source: openFDA Drugs@FDA ↗
26 Dec 2024
US approval
USFDA tentative approval: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
ANDA212243 — EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
20 Dec 2024
US approval
USFDA tentative approval:
NDA209628 — (Type 4 - New Combination)
Source: openFDA Drugs@FDA ↗
10 Dec 2024
US approval
USFDA approval: BEXAROTENE
ANDA210352 — BEXAROTENE
Source: openFDA Drugs@FDA ↗
10 Dec 2024
US approval
USFDA approval: ELIGLUSTAT TARTRATE
ANDA212369 — ELIGLUSTAT TARTRATE
Source: openFDA Drugs@FDA ↗
13 Nov 2024
VAI — minor issues
USFDA inspection classified VAI
Bengaluru · FEI 3002806691 · Cipla Limited, Bengaluru — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
01 Nov 2024
US approval
USFDA tentative approval:
ANDA218028 —
Source: openFDA Drugs@FDA ↗
24 Sep 2024
US approval
USFDA approval: NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
ANDA215592 — NICARDIPINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
20 Sep 2024
US approval
USFDA approval: DIHYDROERGOTAMINE MESYLATE
ANDA212334 — DIHYDROERGOTAMINE MESYLATE
Source: openFDA Drugs@FDA ↗
20 Sep 2024
US approval
USFDA approval: CALCITONIN-SALMON
ANDA213766 — CALCITONIN SALMON
Source: openFDA Drugs@FDA ↗
05 Sep 2024
US approval
USFDA approval: HYDROCORTISONE SODIUM SUCCINATE
ANDA214050 — HYDROCORTISONE SODIUM SUCCINATE
Source: openFDA Drugs@FDA ↗
21 Jun 2024
VAI — minor issues
USFDA inspection classified VAI
Salcette · FEI 3004081307 · Cipla Limited, Salcette — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
08 May 2024
VAI — minor issues
USFDA inspection classified VAI
Kurkumbh Village, Dist. Pune · FEI 3002806702 · Cipla, Ltd., Kurkumbh Village, Dist. Pune — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
04 Apr 2024
VAI — minor issues
USFDA inspection classified VAI
Raigad · FEI 3002806710 · Cipla Limited, Raigad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
11 Mar 2024
US approval
USFDA tentative approval:
ANDA216607 —
Source: openFDA Drugs@FDA ↗
06 Dec 2023
US approval
USFDA approval: VASOPRESSIN
ANDA217987 — VASOPRESSIN
Source: openFDA Drugs@FDA ↗
28 Nov 2023
US approval
USFDA tentative approval: DARUNAVIR
ANDA206288 — DARUNAVIR
Source: openFDA Drugs@FDA ↗
28 Nov 2023
US approval
USFDA approval: DARUNAVIR
ANDA206288 — DARUNAVIR
Source: openFDA Drugs@FDA ↗
17 Nov 2023
Warning letter
USFDA warning letter
Cipla Limited — CGMP/Finished Pharmaceuticals/Adulterated
Source: FDA warning letters ↗
17 Feb 2023
OAI — serious issues
USFDA inspection classified OAI
Pithampur, District Dhar · FEI 3008581988 · Cipla Limited, Pithampur, District Dhar — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
26 Aug 2022
Form 483
Form 483: 2 observations
Salcette · FEI 3004081307 · Cleaning SOPs/schedules; Cleaning System
Source: FDA Data Dashboard (citations) ↗
26 Aug 2022
OAI — serious issues
USFDA inspection classified OAI
Salcette · FEI 3004081307 · Cipla Limited, Salcette — 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/cipla