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 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Emcure Pharmaceuticals and its 3 subsidiaries with 145 drug applications, 27 drug recalls, 1 warning letter and 1 complete response letter. The most recent is a complete response letter dated Jul 28, 2025: Complete response letter, NDA 205508.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Emcure Pharmaceuticals and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 28, 2025 | Complete response letter, NDA 205508Unapproved | Complete response letters |
| Mar 26, 2020 | Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-6Class II · CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product a | Drug recalls |
| Mar 26, 2020 | Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) boClass II · CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product a | Drug recalls |
| Mar 23, 2020 | Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816.Class I · Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules. | Drug recalls |
| Mar 23, 2020 | Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816.Class I · Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules. | Drug recalls |
| Aug 2, 2019 | Warning letter: Aseptic processing, Sterility assurance, Out-of-specificationCDER | Warning 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
