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Laurus Labs — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Laurus Labs (NSE: LAURUSLABS, BSE: 540222), from US FDA records and exchange filings.
63
Compliance score (5 years) · how
6
USFDA-inspected plants on record
1
OAI classifications (5y)
0
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified VAI — 31 Jan 2025 (Lalam Koduru plant). Source: FDA Data Dashboard.
USFDA events by year
2022
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Lalam Koduru Laurus Labs Limited |
3014255847 | VAI | 31 Jan 2025 | |
| Medchal-Malkajgiri Laurus Labs Limited |
3006527015 | NAI | 13 Sep 2024 | |
| Anikapalli District Laurus Labs Limited |
3007083664 | NAI | 19 Apr 2024 | |
| Visakhapatnam Laurus Synthesis Private Limited |
3011524794 | OAI | 12 Dec 2023 | |
| Anakapalli Laurus Labs Limited |
3011538548 | VAI | 10 Feb 2023 | |
| Anakapalli Laurus Labs Limited (Unit-5) |
3017037090 | VAI | 28 Oct 2022 |
Full USFDA timeline
09 Jul 2026
US approval
USFDA tentative approval: TENOFOVIR ALAFENAMIDE FUMARATE
ANDA214030 — TENOFOVIR ALAFENAMIDE FUMARATE
Source: openFDA Drugs@FDA ↗
12 Nov 2025
US approval
USFDA tentative approval: SITAGLIPTIN
ANDA216057 — SITAGLIPTIN
Source: openFDA Drugs@FDA ↗
29 Sep 2025
US approval
USFDA tentative approval: CANAGLIFLOZIN
ANDA210503 — CANAGLIFLOZIN
Source: openFDA Drugs@FDA ↗
31 Jan 2025
VAI — minor issues
USFDA inspection classified VAI
Lalam Koduru · FEI 3014255847 · Laurus Labs Limited, Lalam Koduru — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
13 Sep 2024
NAI — clean
USFDA inspection classified NAI
Medchal-Malkajgiri · FEI 3006527015 · Laurus Labs Limited, Medchal-Malkajgiri — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
19 Apr 2024
NAI — clean
USFDA inspection classified NAI
Anikapalli District · FEI 3007083664 · Laurus Labs Limited, Anikapalli District — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
02 Feb 2024
12 Dec 2023
OAI — serious issues
USFDA inspection classified OAI
Visakhapatnam · FEI 3011524794 · Laurus Synthesis Private Limited, Visakhapatnam — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
10 Feb 2023
VAI — minor issues
USFDA inspection classified VAI
Anakapalli · FEI 3011538548 · Laurus Labs Limited, Anakapalli — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
28 Oct 2022
VAI — minor issues
USFDA inspection classified VAI
Anakapalli · FEI 3017037090 · Laurus Labs Limited (Unit-5), Anakapalli — Pre-Approval Eval. of Animal Drugs and Food Additives (Veterinary)
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/laurus