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 6 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Glenmark Pharmaceuticals and its 3 subsidiaries with 218 drug applications, 149 drug recalls, 4 warning letters and 1 complete response letter. The most recent is a warning letter dated Sep 23, 2026: Warning letter: Drugs.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Glenmark Pharmaceuticals and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 23, 2026 | Warning letter: DrugsCDER | Warning letters |
| Jul 11, 2025 | Warning letter: Cleaning validation, Process validation, Method validationCDER | Warning letters |
| May 1, 2023 | Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made inClass II · Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed | Drug recalls |
| Nov 22, 2022 | Warning letter: Process validation, Method validation, Out-of-specificationCDER | Warning letters |
| Oct 3, 2019 | Warning letter: Stability, Out-of-specification, Quality unitCDER | Warning letters |
| Jun 20, 2019 | Complete response letter, NDA 211746Approved | Complete response letters |
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
