The public registers hold a second record for Apicore Us. The fuller profile, with 35 active US DMFs and 1 valid CEPs, is at Apicore. Figures on this page cover only this record.
Apicore Us is an API manufacturer based in United States. It holds 4 active US drug master files and one valid CEP across a filed portfolio of 4 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 2 April 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Somerset, United States | Not on file |
| East Windsor Township, United States | 3004864046 |
| Molecule | Regulators | Docs |
|---|---|---|
| Busulfan | EDQM, US FDA | 2 |
| Bexarotene | US FDA | 1 |
| Bortezomib | US FDA | 1 |
| Tirzepatide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
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