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Jubilant Pharmova — USFDA Status

Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Jubilant Pharmova (NSE: JUBLPHARMA, BSE: 530019), from US FDA records and exchange filings.

40
Compliance score (5 years) · how
2
USFDA-inspected plants on record
1
OAI classifications (5y)
1
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified VAI — 02 Feb 2024 (Roorkee plant). Source: FDA Data Dashboard.
USFDA events by year
2022
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval

Plants

PlantFEILatest resultLast inspectionHistory (newest first)
Roorkee
Jubilant Generics Limited
 3006895982 VAI 02 Feb 2024
Mysore
Jubilant Pharmova Limited
 3003144728 VAI 13 Dec 2022

Full USFDA timeline

17 Aug 2026
US approval
USFDA approval: TADALAFIL
ANDA210592 — TADALAFIL
Source: openFDA Drugs@FDA ↗
15 May 2026
US approval
USFDA approval: TADALAFIL
ANDA210329 — TADALAFIL
Source: openFDA Drugs@FDA ↗
05 Aug 2025
US approval
USFDA approval: BUMETANIDE
ANDA212470 — BUMETANIDE
Source: openFDA Drugs@FDA ↗
04 Aug 2025
US approval
USFDA approval: ESLICARBAZEPINE ACETATE
ANDA211219 — ESLICARBAZEPINE ACETATE
Source: openFDA Drugs@FDA ↗
20 May 2025
US approval
USFDA approval: PREGABALIN
ANDA209530 — PREGABALIN
Source: openFDA Drugs@FDA ↗
15 Apr 2025
US approval
USFDA approval: RANOLAZINE
ANDA211361 — RANOLAZINE
Source: openFDA Drugs@FDA ↗
11 Apr 2025
US approval
USFDA approval: DEFERASIROX
ANDA211660 — DEFERASIROX
Source: openFDA Drugs@FDA ↗
18 Mar 2025
US approval
USFDA approval: PERPHENAZINE
ANDA213694 — PERPHENAZINE
Source: openFDA Drugs@FDA ↗
06 Mar 2025
US approval
USFDA approval: SILDENAFIL CITRATE
ANDA202954 — SILDENAFIL CITRATE
Source: openFDA Drugs@FDA ↗
03 Mar 2025
US approval
USFDA approval: OSELTAMIVIR PHOSPHATE
ANDA213695 — OSELTAMIVIR PHOSPHATE
Source: openFDA Drugs@FDA ↗
20 Dec 2024
US approval
USFDA approval: SILDENAFIL CITRATE
ANDA201156 — SILDENAFIL CITRATE (Not Applicable)
Source: openFDA Drugs@FDA ↗
06 Dec 2024
US approval
USFDA approval: LURASIDONE HYDROCHLORIDE
ANDA210388 — LURASIDONE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
02 Oct 2024
US approval
USFDA approval: SOLIFENACIN SUCCINATE
ANDA205484 — SOLIFENACIN SUCCINATE
Source: openFDA Drugs@FDA ↗
02 Feb 2024
VAI — minor issues
USFDA inspection classified VAI
Roorkee · FEI 3006895982 · Jubilant Generics Limited, Roorkee — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
13 Dec 2022
VAI — minor issues
USFDA inspection classified VAI
Mysore · FEI 3003144728 · Jubilant Pharmova Limited, Mysore — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
01 Aug 2022
Form 483
Form 483: 3 observations
Roorkee · FEI 3006895982 · Following/documenting laboratory controls; No written record of investigation; Written record of investigation incomplete
Source: FDA Data Dashboard (citations) ↗
01 Aug 2022
OAI — serious issues
USFDA inspection classified OAI
Roorkee · FEI 3006895982 · Jubilant Generics Limited, Roorkee — 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/jubilant-pharmova