RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA

Overview

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA is an active pharmaceutical ingredient (API) supplier with 18 active FDA Type II Drug Master Files, covering ACYCLOVIR; CARGLUMIC ACID; CYSTEAMINE BITARTRATE; CYSTEAMINE HYDROCHLORIDE; DIMENHYDRINATE; DIPHENHYDRAMINE CITRATE.

API / Drug Master Files

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA holds 18 active (37 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.

• OSILODROSTAT PHOSPHATEActive2025-01-07
• CYSTEAMINE BITARTRATEActive2023-04-17
• CYSTEAMINE HYDROCHLORIDEActive2019-01-18
• CARGLUMIC ACIDActive2013-03-06
• PHENYTOINActive2009-10-29
• KETOROLAC TROMETHAMINE ACTIVE PHARMACEUTICAL INGREDIENTActive2007-07-26
• DIPHENHYDRAMINE CITRATEActive2007-02-23
• PYRIDOXAL-5-PHOSPHATEActive2000-06-26
• ACYCLOVIRActive1993-01-12
• DOBUTAMINE HYDROCHLORIDEActive1992-07-02
• FLAVOXATE HYDROCHLORIDEActive1986-07-31
• DOPAMINE HClActive1983-06-10
• VERAPAMIL HYDROCHLORIDEActive1983-01-24
• DIMENHYDRINATEActive1982-07-13
• PHENYTOIN MICROActive1982-04-07

Showing 15 of 37 Drug Master Files.

FDA compliance signals

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