UBE is an API manufacturer based in Japan. It holds 3 active US drug master files across a filed portfolio of 27 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 27 October 2023 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Japan, Japan | 3002808530 |
| Japan, Japan | 3003604942 |
| Molecule | Regulators | Docs |
|---|---|---|
| Methyl Salicylate | PMDA (Japan), US FDA | 2 |
| ピタバスタチンカルシウム | PMDA (Japan) | 2 |
| Bepotastine | US FDA | 1 |
| Etizolam | PMDA (Japan) | 1 |
| Felbinac | PMDA (Japan) | 1 |
| Omidenepag Isopropyl | US FDA | 1 |
| Silodosin | PMDA (Japan) | 1 |
| カルブロック | PMDA (Japan) | 1 |
| クロフェクトン | PMDA (Japan) | 1 |
| サリチル酸ナトリウム | PMDA (Japan) | 1 |
| サリメント | PMDA (Japan) | 1 |
| タスモリン | PMDA (Japan) | 1 |
| チスタニン | PMDA (Japan) | 1 |
| ニフラン | PMDA (Japan) | 1 |
| バイカロン | PMDA (Japan) | 1 |
| ヒバノンＧ－２０ | PMDA (Japan) | 1 |
| ピタバスタチンカルシウム水和物 | PMDA (Japan) | 1 |
| フスタゾール | PMDA (Japan) | 1 |
| フスタゾール散原末 | PMDA (Japan) | 1 |
| ベシル酸ベポタスチン | PMDA (Japan) | 1 |
| メグリン | PMDA (Japan) | 1 |
| メマンチン塩酸塩精製品（解砕品） | PMDA (Japan) | 1 |
| メマンチン塩酸塩（粉砕品） | PMDA (Japan) | 1 |
| レボトミン | PMDA (Japan) | 1 |
| ロスバスタチンカルシウム | PMDA (Japan) | 1 |
| 塩酸ベバントロール－ウベ | PMDA (Japan) | 1 |
| 日本薬局方ニトレンジピン（製造専用） | PMDA (Japan) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
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