OLON SPA

Overview

OLON SPA is an active pharmaceutical ingredient (API) supplier with 167 active FDA Type II Drug Master Files, covering 7 AMINO CEPHALOSPORANIC ACID; ABACAVIR SULFATE; ABIRATERONE ACETATE; ACAMPROSATE CALCIUM; ACECLIDINE BASE; ACECLIDINE HYDROCHLORIDE.

API / Drug Master Files

OLON SPA holds 167 active (189 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.

• TEDUGLUTIDEActive2026-01-26
• ACECLIDINE BASEActive2025-11-25
• LEVOKETOCONAZOLEActive2025-07-31
• AZACITIDINEActive2025-07-17
• EPINEPHRINEActive2024-12-13
• TRILACICLIB DIHYDROCHLORIDEActive2024-06-20
• PRALSETINIBActive2024-05-24
• NINTEDANIB BASEActive2023-12-18
• VALGANCICLOVIR HCL AMORPHOUS TYPE IIActive2023-08-04
• TERBINAFINE HYDROCHLORIDE TYPE-2Active2023-07-27
• ZANUBRUTINIBActive2023-05-12
• CLOFAZIMINE ORTHORHOMBICActive2023-03-23
• UMECLIDINIUM BROMIDEActive2023-03-08
• VALGANCICLOVIR HCL CRYSTALLINE TYPE IIActive2023-02-23
• OLAPARIB FORM AActive2023-02-09

Showing 15 of 189 Drug Master Files.

FDA compliance signals

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