INDENA SPA

Overview

INDENA SPA is an active pharmaceutical ingredient (API) supplier with 17 active FDA Type II Drug Master Files, covering 10-DEACETYLBACCATIN III/R; CABAZITAXEL; CABAZITAXEL ACETONE; CANNABIDIOL; COLCHICINE USP; DOCETAXEL.

API / Drug Master Files

INDENA SPA holds 17 active (21 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.

• CABAZITAXEL ACETONEActive2025-01-27
• VOCLOSPORINActive2024-10-15
• TIRBANIBULINActive2024-10-07
• CANNABIDIOLActive2021-02-16
• CABAZITAXELActive2020-04-17
• RESINIFERATOXINActive2020-03-11
• PACLITAXEL/SWActive2019-10-25
• THIOTEPAActive2019-05-24
• DOCETAXEL TRIHYDRATEActive2018-09-28
• PACLITAXEL/S SEMISYNTHETIC PROCESS, USP/EPActive2013-08-06
• DOCETAXELActive2010-08-30
• N-DEBOC-DOCETAXEL (N-DEBENZOYL-10-DEACETYLPACLITAXEL INTERMEDIATE)Active2010-06-08
• PACLITAXEL/SActive2007-10-22
• PACLITAXEL P.I.Active2002-11-13
• 10-DEACETYLBACCATIN III/RActive1993-08-25

Showing 15 of 21 Drug Master Files.

FDA compliance signals

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