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USFDA Warning Letters to Indian Pharma Companies
Warning letters from the US FDA to listed Indian pharma companies and their units, newest first, with a link to each letter on fda.gov. A close-out letter means FDA considers the issues resolved.
| Issued | Company | Subject | Issuing office | Close-out | Letter |
|---|---|---|---|---|---|
| 26 Feb 2025 | Granules India Limited | CGMP/Finished Pharmaceuticals/Adulterated | Center for Drug Evaluation and Research (CDER) | — | fda.gov ↗ |
| 16 Dec 2024 | Indoco Remedies Limited | CGMP/Finished Pharmaceuticals/Adulterated | Center for Drug Evaluation and Research (CDER) | — | fda.gov ↗ |
| 29 Aug 2024 | Zydus Lifesciences Limited | CGMP/Finished Pharmaceuticals/Adulterated | Center for Drug Evaluation and Research (CDER) | ✓ Closed out | fda.gov ↗ |
| 08 Apr 2024 | Natco Pharma Limited | CGMP/Finished Pharmaceuticals/Adulterated | Center for Drug Evaluation and Research | CDER | ✓ Closed out | fda.gov ↗ |
| 21 Nov 2023 | Intas Pharmaceuticals Limited | CGMP/Finished Pharmaceuticals/Adulterated | Center for Drug Evaluation and Research | CDER | — | fda.gov ↗ |
| 17 Nov 2023 | Cipla Limited | CGMP/Finished Pharmaceuticals/Adulterated | Center for Drug Evaluation and Research | CDER | — | fda.gov ↗ |
| 12 Jan 2022 | Aurobindo Pharmaceutical Limited | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Center for Drug Evaluation and Research | CDER | ✓ Closed out | fda.gov ↗ |