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Zydus Lifesciences — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Zydus Lifesciences (NSE: ZYDUSLIFE, BSE: 532321), from US FDA records and exchange filings.
65
Compliance score (5 years) · how
12
USFDA-inspected plants on record
2
OAI classifications (5y)
2
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: Form 483: 1 observation — 05 May 2026 (Ahmedabad plant). Source: FDA Data Dashboard (citations).
USFDA events by year
2022
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Ahmedabad Zydus Lifesciences Limited |
3012977526 | VAI | 05 May 2026 | |
| Matoda Zydus Lifesciences Limited |
3007621329 | VAI | 17 Jun 2025 | |
| Dabhasa, Vadodara Zydus Lifesciences Limited |
3002806475 | VAI | 25 Apr 2025 | |
| Ankleshwar Zydus Lifesciences Limited |
3003696998 | NAI | 14 Mar 2025 | |
| Ahmedabad Zydus Lifesciences Limited |
3006026405 | NAI | 14 Feb 2025 | |
| Kalyan Zydus Lifesciences Limited |
3006809732 | NAI | 14 Feb 2025 | |
| Ahmedabad Zydus Lifesciences Limited |
3008957483 | VAI | 19 Jul 2024 | |
| Jarod Zydus Lifesciences Limited |
3013712903 | OAI | 23 Apr 2024 | |
| Ahmedabad Zydus Hospira Oncology Private Ltd. |
3007869619 | VAI | 30 Jun 2023 | |
| Matoda, Ahmedabad Zydus Animal Health and Investments Limited |
3015849306 | NAI | 02 Jun 2023 | |
| Matoda Zydus Lifesciences Limited |
3007938603 | VAI | 24 Mar 2023 | |
| Ahmedabad Zydus Lifesciences Limited |
3002984011 | VAI | 05 Aug 2022 |
Full USFDA timeline
27 Oct 2026
US approval
USFDA approval: TRANEXAMIC ACID
ANDA221213 — TRANEXAMIC ACID
Source: openFDA Drugs@FDA ↗
20 Oct 2026
19 Oct 2026
US approval
USFDA approval: ESTRADIOL AND LEVONORGESTREL
ANDA220407 — ESTRADIOL, LEVONORGESTREL
Source: openFDA Drugs@FDA ↗
19 Oct 2026
15 Oct 2026
29 Sep 2026
US approval
USFDA approval: MUPIROCIN CALCIUM
ANDA218361 — MUPIROCIN CALCIUM
Source: openFDA Drugs@FDA ↗
23 Sep 2026
US approval
USFDA approval: MEXILETINE HYDROCHLORIDE
ANDA214598 — MEXILETINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
15 Sep 2026
14 Sep 2026
14 Sep 2026
01 Sep 2026
21 Aug 2026
20 Aug 2026
18 Aug 2026
03 Aug 2026
US approval
USFDA approval: INDOCYANINE GREEN
ANDA219139 — INDOCYANINE GREEN
Source: openFDA Drugs@FDA ↗
22 Jul 2026
21 Jul 2026
US approval
USFDA approval: FLUVOXAMINE MALEATE
ANDA220447 — FLUVOXAMINE MALEATE
Source: openFDA Drugs@FDA ↗
30 Jun 2026
30 Jun 2026
US approval
USFDA tentative approval: METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE
ANDA208535 — METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE
Source: openFDA Drugs@FDA ↗
26 Jun 2026
US approval
USFDA tentative approval: CARBIDOPA; LEODOPA
ANDA210911 — CARBIDOPA, LEODOPA
Source: openFDA Drugs@FDA ↗
05 Jun 2026
US approval
USFDA approval: TOFACITINIB CITRATE
ANDA209829 — TOFACITINIB CITRATE
Source: openFDA Drugs@FDA ↗
01 Jun 2026
US approval
USFDA approval: FLUORESCEIN SODIUM
ANDA218651 — FLUORESCEIN SODIUM
Source: openFDA Drugs@FDA ↗
28 May 2026
15 May 2026
US approval
USFDA approval: AMMONIUM LACTATE
ANDA217758 — AMMONIUM LACTATE
Source: openFDA Drugs@FDA ↗
14 May 2026
US approval
USFDA tentative approval: UBROGEPANT
ANDA218662 — UBROGEPANT
Source: openFDA Drugs@FDA ↗
07 May 2026
US approval
USFDA approval: HYDROCORTISONE SODIUM SUCCINATE
ANDA217191 — HYDROCORTISONE SODIUM SUCCINATE
Source: openFDA Drugs@FDA ↗
05 May 2026
Form 483
Form 483: 1 observation
Ahmedabad · FEI 3012977526 · Floors, walls, ceiling surfaces
Source: FDA Data Dashboard (citations) ↗
05 May 2026
VAI — minor issues
USFDA inspection classified VAI
Ahmedabad · FEI 3012977526 · Zydus Lifesciences Limited, Ahmedabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
06 Apr 2026
11 Mar 2026
US approval
USFDA approval: CEVIMELINE HYDROCHLORIDE
ANDA220267 — CEVIMELINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
04 Mar 2026
US approval
USFDA approval: CALCITONIN-SALMON
ANDA215864 — CALCITONIN SALMON
Source: openFDA Drugs@FDA ↗
26 Feb 2026
26 Feb 2026
17 Feb 2026
13 Feb 2026
12 Feb 2026
US approval
USFDA approval: AMMONIUM LACTATE
ANDA217815 — AMMONIUM LACTATE
Source: openFDA Drugs@FDA ↗
29 Jan 2026
US approval
USFDA approval: SERTRALINE HYDROCHLORIDE
ANDA220275 — SERTRALINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
14 Jan 2026
US approval
USFDA approval: ELTROMBOPAG OLAMINE
ANDA216281 — ELTROMBOPAG OLAMINE
Source: openFDA Drugs@FDA ↗
25 Nov 2025
US approval
USFDA tentative approval: EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
ANDA217049 — EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
25 Nov 2025
24 Nov 2025
US approval
USFDA approval: VERAPAMIL HYDROCHLORIDE
ANDA219252 — VERAPAMIL HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
13 Nov 2025
US approval
USFDA approval: LEUPROLIDE ACETATE
ANDA215826 — LEUPROLIDE ACETATE
Source: openFDA Drugs@FDA ↗
12 Nov 2025
US approval
USFDA approval: DIROXIMEL FUMARATE
ANDA218596 — DIROXIMEL FUMARATE
Source: openFDA Drugs@FDA ↗
06 Nov 2025
03 Nov 2025
03 Oct 2025
08 Aug 2025
US approval
USFDA tentative approval: CARBIDOPA; LEODOPA
ANDA210911 — CARBIDOPA, LEODOPA
Source: openFDA Drugs@FDA ↗
08 Aug 2025
US approval
USFDA approval: DILTIAZEM HYDROCHLORIDE
ANDA219253 — DILTIAZEM HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
07 Aug 2025
US approval
USFDA approval: PRUCALOPRIDE SUCCINATE
ANDA218056 — PRUCALOPRIDE SUCCINATE
Source: openFDA Drugs@FDA ↗
22 Jul 2025
14 Jul 2025
17 Jun 2025
VAI — minor issues
USFDA inspection classified VAI
Matoda · FEI 3007621329 · Zydus Lifesciences Limited, Matoda — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
30 May 2025
22 May 2025
28 Apr 2025
25 Apr 2025
VAI — minor issues
USFDA inspection classified VAI
Dabhasa, Vadodara · FEI 3002806475 · Zydus Lifesciences Limited, Dabhasa, Vadodara — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
08 Apr 2025
17 Mar 2025
14 Mar 2025
14 Mar 2025
NAI — clean
USFDA inspection classified NAI
Ankleshwar · FEI 3003696998 · Zydus Lifesciences Limited, Ankleshwar — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
10 Mar 2025
US approval
USFDA approval: METHENAMINE HIPPURATE
ANDA219661 — METHENAMINE HIPPURATE
Source: openFDA Drugs@FDA ↗
07 Mar 2025
03 Mar 2025
20 Feb 2025
US approval
USFDA approval: IBUPROFEN AND FAMOTIDINE
ANDA218684 — FAMOTIDINE, IBUPROFEN
Source: openFDA Drugs@FDA ↗
14 Feb 2025
NAI — clean
USFDA inspection classified NAI
Kalyan · FEI 3006809732 · Zydus Lifesciences Limited, Kalyan — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
14 Feb 2025
NAI — clean
USFDA inspection classified NAI
Ahmedabad · FEI 3006026405 · Zydus Lifesciences Limited, Ahmedabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
17 Dec 2024
US approval
USFDA approval: LIDOCAINE AND PRILOCAINE
ANDA219120 — LIDOCAINE, PRILOCAINE
Source: openFDA Drugs@FDA ↗
16 Oct 2024
US approval
USFDA approval: FLUDROCORTISONE ACETATE
ANDA219251 — FLUDROCORTISONE ACETATE
Source: openFDA Drugs@FDA ↗
08 Oct 2024
30 Sep 2024
US approval
USFDA tentative approval: ENZALUTAMIDE
ANDA217322 — ENZALUTAMIDE
Source: openFDA Drugs@FDA ↗
26 Sep 2024
29 Aug 2024
29 Aug 2024
Warning letter
USFDA warning letter
Zydus Lifesciences Limited — CGMP/Finished Pharmaceuticals/Adulterated (close-out issued)
Source: FDA warning letters ↗
26 Aug 2024
US approval
USFDA tentative approval: AMANTADINE, AMANTADINE HYDROCHLORIDE
ANDA214897 — AMANTADINE, AMANTADINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
26 Aug 2024
US approval
USFDA approval: AMANTADINE, AMANTADINE HYDROCHLORIDE
ANDA214897 — AMANTADINE, AMANTADINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
07 Aug 2024
US approval
USFDA approval: VALBENAZINE TOSYLATE
ANDA216137 — VALBENAZINE TOSYLATE
Source: openFDA Drugs@FDA ↗
22 Jul 2024
19 Jul 2024
VAI — minor issues
USFDA inspection classified VAI
Ahmedabad · FEI 3008957483 · Zydus Lifesciences Limited, Ahmedabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
18 Jul 2024
US approval
USFDA approval: ZITUVIMET XR
NDA216778 — METFORMIN HYDROCHLORIDE, SITAGLIPTIN (Type 5 - New Formulation or New Manufacturer)
Source: openFDA Drugs@FDA ↗
09 Jul 2024
US approval
USFDA approval: SACUBITRIL AND VALSARTAN
ANDA213719 — SACUBITRIL, VALSARTAN
Source: openFDA Drugs@FDA ↗
03 Jul 2024
12 Jun 2024
05 Jun 2024
21 May 2024
09 May 2024
08 May 2024
25 Apr 2024
23 Apr 2024
OAI — serious issues
USFDA inspection classified OAI
Jarod · FEI 3013712903 · Zydus Lifesciences Limited, Jarod — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
02 Apr 2024
US approval
USFDA tentative approval: VORTIOXETINE HYDROBROMIDE
ANDA211146 — VORTIOXETINE HYDROBROMIDE
Source: openFDA Drugs@FDA ↗
27 Mar 2024
OAI — serious issues
USFDA inspection classified OAI
Matoda · FEI 3007621329 · Zydus Lifesciences Limited, Matoda — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
22 Mar 2024
US approval
USFDA tentative approval: LETERMOVIR
ANDA216799 — LETERMOVIR
Source: openFDA Drugs@FDA ↗
15 Mar 2024
US approval
USFDA approval: FINASTERIDE AND TADALAFIL
ANDA218232 — FINASTERIDE, TADALAFIL
Source: openFDA Drugs@FDA ↗
13 Mar 2024
US approval
USFDA approval: CHLORPROMAZINE HYDROCHLORIDE
ANDA217275 — CHLORPROMAZINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
15 Feb 2024
US approval
USFDA approval: ISOSORBIDE MONONITRATE
ANDA218255 — ISOSORBIDE MONONITRATE
Source: openFDA Drugs@FDA ↗
07 Feb 2024
07 Feb 2024
24 Jan 2024
16 Jan 2024
US approval
USFDA approval: PIMAVANSERIN
ANDA214502 — PIMAVANSERIN TARTRATE
Source: openFDA Drugs@FDA ↗
16 Jan 2024
US approval
USFDA approval: PIMAVANSERIN
ANDA214493 — PIMAVANSERIN TARTRATE
Source: openFDA Drugs@FDA ↗
15 Dec 2023
13 Dec 2023
US approval
USFDA approval: CYCLOPHOSPHAMIDE
ANDA211552 — CYCLOPHOSPHAMIDE
Source: openFDA Drugs@FDA ↗
13 Dec 2023
13 Dec 2023
05 Dec 2023
29 Nov 2023
US approval
USFDA approval: IVABRADINE HYDROCHLORIDE
ANDA213442 — IVABRADINE HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
30 Jun 2023
VAI — minor issues
USFDA inspection classified VAI
Ahmedabad · FEI 3007869619 · Zydus Hospira Oncology Private Ltd., Ahmedabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
13 Jun 2023
NAI — clean
USFDA inspection classified NAI
Ahmedabad · FEI 3012977526 · Zydus Lifesciences Limited, Ahmedabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
02 Jun 2023
NAI — clean
USFDA inspection classified NAI
Matoda, Ahmedabad · FEI 3015849306 · Zydus Animal Health and Investments Limited, Matoda, Ahmedabad — Pre-Approval Eval. of Animal Drugs and Food Additives (Veterinary)
Source: FDA Data Dashboard ↗
24 Mar 2023
VAI — minor issues
USFDA inspection classified VAI
Matoda · FEI 3007938603 · Zydus Lifesciences Limited, Matoda — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
29 Sep 2022
VAI — minor issues
USFDA inspection classified VAI
Matoda, Ahmedabad · FEI 3015849306 · Zydus Animal Health and Investments Limited, Matoda, Ahmedabad — Pre-Approval Eval. of Animal Drugs and Food Additives (Veterinary)
Source: FDA Data Dashboard ↗
05 Aug 2022
Form 483
Form 483: 2 observations
Ahmedabad · FEI 3002984011 · Establishment of time limitations; Procedures To Be in Writing
Source: FDA Data Dashboard (citations) ↗
05 Aug 2022
VAI — minor issues
USFDA inspection classified VAI
Ahmedabad · FEI 3002984011 · Zydus Lifesciences Limited, Ahmedabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
10 Mar 2022
VAI — minor issues
USFDA inspection classified VAI
Jarod · FEI 3013712903 · Zydus Lifesciences Limited, Jarod — 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/zydus-lifesciences