Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IndiaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Granules India and its 4 subsidiaries with 71 drug applications, 14 drug recalls and 1 warning letter. The most recent is a warning letter dated Feb 26, 2025: Warning letter: Data integrity, Cleaning validation, Quality unit.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Granules India and its 4 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Feb 26, 2025 | Warning letter: Data integrity, Cleaning validation, Quality unitCDER | Warning letters |
| Aug 11, 2021 | Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village,Class II · CGMP Deviations | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
