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 8 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Lupin and its 6 subsidiaries with 373 drug applications, 146 drug recalls, 3 warning letters and 1 complete response letter. The most recent is a complete response letter dated Nov 14, 2024: Complete response letter, BLA 761212.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Lupin and its 6 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Nov 14, 2024 | Complete response letter, BLA 761212Unapproved | Complete response letters |
| Jul 2, 2024 | PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.0Class III · Defective container: potential for non-sealed pouches which can lead to product leakage. | Drug recalls |
| Sep 27, 2022 | Warning letter: Cleaning validation, Out-of-specification, Quality unitCDER | Warning letters |
| Sep 10, 2019 | Warning letter: Cleaning validation, Process validation, Out-of-specificationCDER | Warning letters |
| Nov 6, 2017 | Warning letter: Stability, 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
