Ono Pharmaceutical Co., Ltd.

Overview

Ono Pharmaceutical Co., Ltd. is a Japanese pharmaceutical company primarily involved in research, development, manufacture, and sales of pharmaceuticals. The company's innovative medicines target a wide array of diseases and conditions, including those in oncology and autoimmune disorders.

Therapeutic areas

API / Drug Master Files

Ono Pharmaceutical Co., Ltd. holds 100 active (144 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• DAROLUTAMIDEActive2026-03-30
• CARFILZOMIBActive2025-12-31
• TIRZEPATIDE TETRAPEPTIDE FRAGMENTActive2025-09-28
• ORFORGLIPRON INTERMEDIATE IIIActive2025-09-12
• ORFORGLIPRON INTERMEDIATE IVActive2025-09-04
• TIRZEPATIDE SIDE CHAIN FRAGMENTActive2025-08-22
• UBROGEPANTActive2025-06-24
• ORFORGLIPRON INTERMEDIATE IIActive2025-06-08
• ORFORGLIPRON INTERMEDIATE IActive2025-06-05
• ORFORGLIPRONActive2025-05-29
• FONDAPARINUX SODIUMActive2025-05-25
• FASUDIL HYDROCHLORIDE HYDRATEActive2025-05-06
• MOXIFLOXACIN HYDROCHLORIDEActive2025-04-29
• GEFITINIBActive2025-03-27
• SEMAGLUTIDE FERMENTATION SIDE CHAINActive2025-03-18

Showing 15 of 144 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Ono Pharmaceutical Co., Ltd. in our records. PharmaTek screens the full directory against live FDA enforcement data.