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Mankind Pharma — USFDA Status

Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Mankind Pharma (NSE: MANKIND, BSE: 543904), from US FDA records and exchange filings.

60
Compliance score (5 years) · how
3
USFDA-inspected plants on record
0
OAI classifications (5y)
0
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified VAI — 26 Apr 2025 (Kotputli-Behror 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)
Kotputli-Behror
Mankind Pharma Limited
 3014150265 VAI 26 Apr 2025
Gurugram
Mankind Pharma Limited
 3013913573 VAI 13 Apr 2023
Rampur Ghat
Mankind Pharma Limited
 3009083745 VAI 25 Feb 2022

Full USFDA timeline

31 Jul 2026
US approval
USFDA approval: THIAMINE HYDROCHLORIDE
ANDA220513 — THIAMINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
28 Jul 2026
US approval
USFDA approval: SUGAMMADEX SODIUM
ANDA214230 — SUGAMMADEX SODIUM
Source: openFDA Drugs@FDA ↗
01 Jul 2026
US approval
USFDA approval: RIVAROXABAN
ANDA220874 — RIVAROXABAN
Source: openFDA Drugs@FDA ↗
21 May 2026
US approval
USFDA tentative approval: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA218405 — SITAGLIPTIN, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
16 Apr 2026
US approval
USFDA approval: BRIMONIDINE TARTRATE
ANDA220398 — BRIMONIDINE TARTRATE
Source: openFDA Drugs@FDA ↗
06 Feb 2026
US approval
USFDA approval: TICAGRELOR
ANDA217679 — TICAGRELOR
Source: openFDA Drugs@FDA ↗
04 Feb 2026
US approval
USFDA tentative approval:
ANDA212283 —
Source: openFDA Drugs@FDA ↗
27 Jan 2026
US approval
USFDA approval: PROPRANOLOL HYDROCHLORIDE
ANDA216663 — PROPRANOLOL HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
02 Jan 2026
US approval
USFDA approval: EXTENDED PHENYTOIN SODIUM
ANDA219773 — PHENYTOIN SODIUM
Source: openFDA Drugs@FDA ↗
17 Dec 2025
US approval
USFDA approval: LATANOPROST
ANDA220360 — LATANOPROST
Source: openFDA Drugs@FDA ↗
12 Aug 2025
US approval
USFDA approval: DIVALPROEX SODIUM
ANDA217358 — DIVALPROEX SODIUM
Source: openFDA Drugs@FDA ↗
29 May 2025
US approval
USFDA approval: ROCURONIUM BROMIDE
ANDA219674 — ROCURONIUM BROMIDE
Source: openFDA Drugs@FDA ↗
21 May 2025
US approval
USFDA approval: PROPARACAINE HYDROCHLORIDE
ANDA219136 — PROPARACAINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
16 May 2025
US approval
USFDA approval: ROSUVASTATIN CALCIUM
ANDA206603 — ROSUVASTATIN CALCIUM
Source: openFDA Drugs@FDA ↗
26 Apr 2025
VAI — minor issues
USFDA inspection classified VAI
Kotputli-Behror · FEI 3014150265 · Mankind Pharma Limited, Kotputli-Behror — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
03 Apr 2025
US approval
USFDA approval: BUMETANIDE
ANDA219291 — BUMETANIDE
Source: openFDA Drugs@FDA ↗
17 Mar 2025
US approval
USFDA approval: BIMATOPROST
ANDA218196 — BIMATOPROST
Source: openFDA Drugs@FDA ↗
03 Mar 2025
US approval
USFDA approval: TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA218406 — HYDROCHLOROTHIAZIDE, TELMISARTAN
Source: openFDA Drugs@FDA ↗
27 Jan 2025
US approval
USFDA approval: MOXIFLOXACIN HYDROCHLORIDE
ANDA217988 — MOXIFLOXACIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
06 Jan 2025
US approval
USFDA tentative approval: REVEFENACIN
ANDA218089 — REVEFENACIN
Source: openFDA Drugs@FDA ↗
11 Dec 2024
US approval
USFDA tentative approval: SITAGLIPTIN AND METFORMIN HCL
ANDA218971 — SITAGLIPTIN, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
21 Oct 2024
US approval
USFDA approval: LEVALBUTEROL HYDROCHLORIDE
ANDA218770 — LEVALBUTEROL HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
15 Oct 2024
US approval
USFDA approval: TELMISARTAN
ANDA218157 — TELMISARTAN
Source: openFDA Drugs@FDA ↗
10 Jul 2024
US approval
USFDA approval: CYANOCOBALAMIN
ANDA217839 — CYANOCOBALAMIN
Source: openFDA Drugs@FDA ↗
11 Apr 2024
US approval
USFDA approval: HALOPERIDOL
ANDA216918 — HALOPERIDOL
Source: openFDA Drugs@FDA ↗
29 Feb 2024
US approval
USFDA approval: NALOXONE HYDROCHLORIDE
ANDA218404 — NALOXONE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
07 Feb 2024
US approval
USFDA approval: APREMILAST
ANDA211734 — APREMILAST
Source: openFDA Drugs@FDA ↗
08 Jan 2024
US approval
USFDA approval: ATROPINE SULFATE
ANDA218148 — ATROPINE SULFATE
Source: openFDA Drugs@FDA ↗
05 Jan 2024
US approval
USFDA approval: ATORVASTATIN CALCIUM
ANDA217081 — ATORVASTATIN CALCIUM
Source: openFDA Drugs@FDA ↗
02 Jan 2024
US approval
USFDA tentative approval: SITAGLIPTIN
ANDA216919 — SITAGLIPTIN PHOSPHATE
Source: openFDA Drugs@FDA ↗
05 Dec 2023
US approval
USFDA approval: NITROGLYCERIN
ANDA217970 — NITROGLYCERIN
Source: openFDA Drugs@FDA ↗
13 Apr 2023
VAI — minor issues
USFDA inspection classified VAI
Gurugram · FEI 3013913573 · Mankind Pharma Limited, Gurugram — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
25 Feb 2022
VAI — minor issues
USFDA inspection classified VAI
Rampur Ghat · FEI 3009083745 · Mankind Pharma Limited, Rampur Ghat — 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/mankind