Pharmaceutical companyLabelled 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., part of Sun Pharma. FDA records under 13 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Sun Pharmaceutical Industries with 422 drug applications, 141 drug recalls, 4 complete response letters, 2 warning letters and 1 510(k) clearance. The most recent is a complete response letter dated Jun 25, 2025: Complete response letter, NDA 215644.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 25, 2025 | Complete response letter, NDA 215644Unapproved | Complete response letters |
| Oct 25, 2024 | Complete response letter, NDA 215644Unapproved | Complete response letters |
| Jun 18, 2024 | Warning letter: Cleaning validation, Out-of-specification, Quality unitCDER | Warning letters |
| Jun 13, 2024 | BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170EK241358 · GEX | 510(k) clearances |
| Oct 16, 2023 | Warning letter: Aseptic processing, Sterility assurance, Cleaning validationCDER | Warning letters |
| Apr 19, 2023 | Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, StClass II · Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. | Drug recalls |
| May 23, 2017 | Complete response letter, NDA 208313Approved | Complete response letters |
| Nov 24, 2015 | Complete response letter, NDA 208313Approved | 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
