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Dr. Reddy's Laboratories — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Dr. Reddy's Laboratories (NSE: DRREDDY, BSE: 500124), from US FDA records and exchange filings.
71
Compliance score (5 years) · how
12
USFDA-inspected plants on record
0
OAI classifications (5y)
1
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified NAI — 14 Nov 2025 (Ransthalam Mandal, Srikakulam District plant). Source: FDA Data Dashboard.
USFDA events by year
2021
2022
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Ransthalam Mandal, Srikakulam District Dr. Reddy's Laboratories Limited |
3005336882 | NAI | 14 Nov 2025 | |
| Pydibhimavaram Dr. Reddy's Laboratories Limited |
3012414462 | VAI | 18 Jul 2025 | |
| Nalgonda Dr. Reddy's Laboratories Limited |
3005447965 | VAI | 24 May 2025 | |
| Jinnaram Mandal, Hyderabad Dr. Reddy's Laboratories Limited (Unit II) |
3005448030 | VAI | 19 Nov 2024 | |
| Medchal-Malkajgiri DR. REDDY'S LABORATORIES LTD |
3014250111 | NAI | 20 Sep 2024 | |
| Srikakulam Dr. Reddy's Laboratories Limited CTO VI |
3002949085 | VAI | 07 Jun 2024 | |
| Visakhapatnam Dr. Reddy's Laboratories Ltd. |
3006549835 | VAI | 17 May 2024 | |
| Medchal-Malkajgiri District Dr. Reddy's Laboratories Ltd. |
3002949099 | VAI | 27 Oct 2023 | |
| Jinnaram Dr. Reddy's Laboratories Limited (Chemical Tech Ops - III) |
3003184497 | NAI | 16 Jun 2023 | |
| Ranasthalam Mandal, Srikakulam Dr. Reddy's Laboratories Ltd. |
3011171511 | VAI | 12 May 2023 | |
| Sangareddy, Hyderabad Dr. Reddy's Laboratories Ltd, CTO Unit 1 |
3002806851 | VAI | 05 May 2023 | |
| Srikakulam Dr Reddy's Laboratories Limited |
3009193040 | VAI | 20 May 2022 |
Full USFDA timeline
23 Oct 2026
16 Oct 2026
US approval
USFDA approval: LORATADINE AND PSEUDOEPHEDRINE SULFATE
ANDA220432 — LORATADINE, PSEUDOEPHEDRINE SULFATE
Source: openFDA Drugs@FDA ↗
31 Aug 2026
18 Aug 2026
US approval
USFDA tentative approval: CARBIDOPA AND LEVODOPA
ANDA219231 — CARBIDOPA, LEVODOPA
Source: openFDA Drugs@FDA ↗
06 Aug 2026
US approval
USFDA approval: LORATADINE AND PSEUDOEPHEDRINE SULFATE
ANDA220448 — LORATADINE, PSEUDOEPHEDRINE SULFATE
Source: openFDA Drugs@FDA ↗
06 Aug 2026
31 Jul 2026
30 Jul 2026
US approval
USFDA approval: FEXOFENADINE HYDROCHLORIDE
ANDA220413 — FEXOFENADINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
28 Jul 2026
US approval
USFDA approval: SUGAMMADEX SODIUM
ANDA214236 — SUGAMMADEX SODIUM
Source: openFDA Drugs@FDA ↗
17 Jul 2026
US approval
USFDA tentative approval: SITAGLIPTIN PHOSPHATE
ANDA214700 — SITAGLIPTIN PHOSPHATE
Source: openFDA Drugs@FDA ↗
26 Jun 2026
15 May 2026
15 May 2026
US approval
USFDA tentative approval: PALBOCICLIB
ANDA220444 — PALBOCICLIB
Source: openFDA Drugs@FDA ↗
15 May 2026
07 May 2026
17 Apr 2026
02 Apr 2026
US approval
USFDA approval: NINTEDANIB ESYLATE
ANDA219283 — NINTEDANIB ESYLATE
Source: openFDA Drugs@FDA ↗
16 Mar 2026
US approval
USFDA approval: ELTROMBOPAG, ELTROMBOPAG OLAMINE
ANDA219121 — ELTROMBOPAG, ELTROMBOPAG OLAMINE
Source: openFDA Drugs@FDA ↗
25 Feb 2026
US approval
USFDA approval: DEXMEDETOMIDINE HYDROCHLORIDE
ANDA220315 — DEXMEDETOMIDINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
19 Nov 2025
US approval
USFDA approval: NILOTINIB HYDROCHLORIDE
ANDA218350 — NILOTINIB HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
14 Nov 2025
NAI — clean
USFDA inspection classified NAI
Ransthalam Mandal, Srikakulam District · FEI 3005336882 · Dr. Reddy's Laboratories Limited, Ransthalam Mandal, Srikakulam District — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
03 Nov 2025
03 Nov 2025
US approval
USFDA approval: LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA208427 — LINAGLIPTIN, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
28 Oct 2025
23 Oct 2025
03 Oct 2025
01 Oct 2025
06 Aug 2025
US approval
USFDA tentative approval: LUMATEPERONE
ANDA219229 — LUMATEPERONE
Source: openFDA Drugs@FDA ↗
18 Jul 2025
VAI — minor issues
USFDA inspection classified VAI
Pydibhimavaram · FEI 3012414462 · Dr. Reddy's Laboratories Limited, Pydibhimavaram — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
17 Jul 2025
03 Jul 2025
US approval
USFDA approval: ERIBULIN MESYLATE
ANDA217473 — ERIBULIN MESYLATE
Source: openFDA Drugs@FDA ↗
01 Jul 2025
US approval
USFDA approval: DOXYCYCLINE HYCLATE
ANDA218753 — DOXYCYCLINE HYCLATE
Source: openFDA Drugs@FDA ↗
12 Jun 2025
US approval
USFDA approval: PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE
ANDA208175 — PHENTERMINE HYDROCHLORIDE, TOPIRAMATE
Source: openFDA Drugs@FDA ↗
05 Jun 2025
30 May 2025
US approval
USFDA approval: PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
NDA216830 — PHENYLEPHRINE HYDROCHLORIDE (Type 5 - New Formulation or New Manufacturer)
Source: openFDA Drugs@FDA ↗
30 May 2025
24 May 2025
VAI — minor issues
USFDA inspection classified VAI
Nalgonda · FEI 3005447965 · Dr. Reddy's Laboratories Limited, Nalgonda — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
19 May 2025
US approval
USFDA approval: PROCHLORPERAZINE MALEATE
ANDA217847 — PROCHLORPERAZINE MALEATE
Source: openFDA Drugs@FDA ↗
14 May 2025
11 Apr 2025
US approval
USFDA approval: TRIAMCINOLONE ACETONIDE
ANDA218421 — TRIAMCINOLONE ACETONIDE
Source: openFDA Drugs@FDA ↗
09 Apr 2025
12 Mar 2025
US approval
USFDA approval: TRIAMCINOLONE ACETONIDE
ANDA218773 — TRIAMCINOLONE ACETONIDE
Source: openFDA Drugs@FDA ↗
10 Mar 2025
03 Mar 2025
19 Feb 2025
30 Jan 2025
US approval
USFDA approval: FORMOTEROL FUMARATE
ANDA215907 — FORMOTEROL FUMARATE
Source: openFDA Drugs@FDA ↗
28 Jan 2025
US approval
USFDA approval: DABIGATRAN ETEXILATE MESYLATE
ANDA208048 — DABIGATRAN ETEXILATE MESYLATE
Source: openFDA Drugs@FDA ↗
13 Jan 2025
US approval
USFDA approval: SACUBITRIL AND VALSARTAN
ANDA213627 — SACUBITRIL, VALSARTAN
Source: openFDA Drugs@FDA ↗
19 Nov 2024
VAI — minor issues
USFDA inspection classified VAI
Jinnaram Mandal, Hyderabad · FEI 3005448030 · Dr. Reddy's Laboratories Limited (Unit II), Jinnaram Mandal, Hyderabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
29 Oct 2024
01 Oct 2024
US approval
USFDA approval: VARENICLINE TARTRATE
ANDA215931 — VARENICLINE TARTRATE
Source: openFDA Drugs@FDA ↗
20 Sep 2024
NAI — clean
USFDA inspection classified NAI
Medchal-Malkajgiri · FEI 3014250111 · DR. REDDY'S LABORATORIES LTD, Medchal-Malkajgiri — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
23 Aug 2024
US approval
USFDA approval: ACETAMINOPHEN AND IBUPROFEN
ANDA218247 — ACETAMINOPHEN, IBUPROFEN
Source: openFDA Drugs@FDA ↗
18 Jul 2024
05 Jul 2024
28 Jun 2024
07 Jun 2024
VAI — minor issues
USFDA inspection classified VAI
Srikakulam · FEI 3002949085 · Dr. Reddy's Laboratories Limited CTO VI, Srikakulam — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
03 Jun 2024
US approval
USFDA approval: ARFORMOTEROL TARTRATE
ANDA215032 — ARFORMOTEROL TARTRATE
Source: openFDA Drugs@FDA ↗
17 May 2024
VAI — minor issues
USFDA inspection classified VAI
Visakhapatnam · FEI 3006549835 · Dr. Reddy's Laboratories Ltd., Visakhapatnam — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
09 May 2024
US approval
USFDA approval: OMEPRAZOLE AND SODIUM BICARBONATE
ANDA217784 — OMEPRAZOLE, SODIUM BICARBONATE
Source: openFDA Drugs@FDA ↗
08 May 2024
US approval
USFDA approval: VASOPRESSIN, VASOPRESSIN IN DEXTROSE 5%
ANDA213988 — VASOPRESSIN
Source: openFDA Drugs@FDA ↗
06 May 2024
30 Apr 2024
US approval
USFDA approval: ESOMEPRAZOLE MAGNESIUM
ANDA207198 — ESOMEPRAZOLE MAGNESIUM
Source: openFDA Drugs@FDA ↗
11 Apr 2024
US approval
USFDA approval: CALCITONIN-SALMON
ANDA215715 — CALCITONIN SALMON
Source: openFDA Drugs@FDA ↗
08 Apr 2024
25 Mar 2024
16 Feb 2024
US approval
USFDA approval: BRIMONIDINE TARTRATE
ANDA216361 — BRIMONIDINE TARTRATE
Source: openFDA Drugs@FDA ↗
17 Jan 2024
US approval
USFDA approval: SUCCINYLCHOLINE CHLORIDE
ANDA218467 — SUCCINYLCHOLINE CHLORIDE
Source: openFDA Drugs@FDA ↗
08 Dec 2023
VAI — minor issues
USFDA inspection classified VAI
Medchal-Malkajgiri · FEI 3014250111 · DR. REDDY'S LABORATORIES LTD, Medchal-Malkajgiri — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
28 Nov 2023
17 Nov 2023
27 Oct 2023
Form 483
Form 483: 1 observation
Medchal-Malkajgiri District · FEI 3002949099 · Instruments, apparatus, et. al. not meeting specs
Source: FDA Data Dashboard (citations) ↗
27 Oct 2023
VAI — minor issues
USFDA inspection classified VAI
Medchal-Malkajgiri District · FEI 3002949099 · Dr. Reddy's Laboratories Ltd., Medchal-Malkajgiri District — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
19 Jul 2023
NAI — clean
USFDA inspection classified NAI
Srikakulam · FEI 3002949085 · Dr. Reddy's Laboratories Limited CTO VI, Srikakulam — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
16 Jun 2023
NAI — clean
USFDA inspection classified NAI
Jinnaram · FEI 3003184497 · Dr. Reddy's Laboratories Limited (Chemical Tech Ops - III), Jinnaram — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
12 May 2023
VAI — minor issues
USFDA inspection classified VAI
Ranasthalam Mandal, Srikakulam · FEI 3011171511 · Dr. Reddy's Laboratories Ltd., Ranasthalam Mandal, Srikakulam — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
05 May 2023
VAI — minor issues
USFDA inspection classified VAI
Sangareddy, Hyderabad · FEI 3002806851 · Dr. Reddy's Laboratories Ltd, CTO Unit 1, Sangareddy, Hyderabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
20 May 2022
VAI — minor issues
USFDA inspection classified VAI
Srikakulam · FEI 3009193040 · Dr Reddy's Laboratories Limited, Srikakulam — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
29 Oct 2021
VAI — minor issues
USFDA inspection classified VAI
Visakhapatnam · FEI 3006549835 · Dr. Reddy's Laboratories Ltd., Visakhapatnam — 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/dr-reddys