STEROID SPA

Overview

STEROID SPA is an active pharmaceutical ingredient (API) supplier with 10 active FDA Type II Drug Master Files, covering CLASCOTERONE; DIFLUPREDNATE; ESTRADIOL VALERATE; ETONOGESTREL; FULVESTRANT; HYDROXYPROGESTERONE CAPROATE.

API / Drug Master Files

STEROID SPA holds 10 active (10 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.

• NORETHINDRONE ACETATEActive2026-01-14
• CLASCOTERONEActive2025-05-16
• ESTRADIOL VALERATEActive2024-03-20
• ETONOGESTRELActive2024-02-28
• FULVESTRANTActive2023-03-16
• TESTOSTERONE CYPIONATEActive2018-06-29
• DIFLUPREDNATEActive2018-05-10
• TESTOSTERONE ENANTHATEActive2018-04-27
• HYDROXYPROGESTERONE CAPROATEActive2017-01-18
• TESTOSTERONE UNDECANOATEActive2013-09-26

FDA compliance signals

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