FLAMMA SPA

Overview

FLAMMA SPA is an active pharmaceutical ingredient (API) supplier with 7 active FDA Type II Drug Master Files, covering AZELAIC ACID; L-PHOSPHOSERINE; LABETALOL HYDROCHLORIDE; LAUROYL-L-CARNITINE HYDROCHLORIDE; MELATONIN; MINOXIDIL.

API / Drug Master Files

FLAMMA SPA holds 7 active (11 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.

• L-PHOSPHOSERINEActive2024-08-06
• LAUROYL-L-CARNITINE HYDROCHLORIDEActive2023-12-20
• AZELAIC ACIDActive2023-02-24
• MELATONINActive2009-03-12
• VALACYCLOVIR HYDROCHLORIDEActive2004-10-25
• LABETALOL HYDROCHLORIDEActive2002-12-17
• MINOXIDILActive2002-03-29
• LOSARTAN POTASSIUMInactive2009-11-23
• SULINDACInactive2007-07-30
• LANSOPRAZOLEInactive2006-03-03
• MODAFINILInactive2005-02-03

FDA compliance signals

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