AGNO PHARMA USA

Overview

AGNO PHARMA USA is an active pharmaceutical ingredient (API) supplier with 12 active FDA Type II Drug Master Files, covering +(1S,4R)-P-MENTHADIENOL; 3-(N, N-DIMETHYLAMINOMETHYL)-5-METHYL-2-HEXANONE OXALATE; 6,7-DIMETHOXY-3,4-DIHYDROISOQUINOLINE HYDROCHLORIDE; CANNABIDIOL; CARMUSTINE USP; INDOMETHACIN USP.

API / Drug Master Files

AGNO PHARMA USA holds 12 active (14 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.

• SULINDACActive2025-07-11
• INDOMETHACIN USPActive2024-10-10
• TETRABENAZINEActive2024-08-28
• 6,7-DIMETHOXY-3,4-DIHYDROISOQUINOLINE HYDROCHLORIDEActive2024-06-28
• 3-(N, N-DIMETHYLAMINOMETHYL)-5-METHYL-2-HEXANONE OXALATEActive2024-06-28
• POLIDOCANOLActive2024-06-17
• CANNABIDIOLActive2020-08-19
• ISOSULFAN BLUEActive2020-07-15
• OLIVETOLActive2018-12-10
• +(1S,4R)-P-MENTHADIENOLActive2018-12-01
• CARMUSTINE USPActive2017-03-24
• SODIUM TETRADECYL SULFATEActive2016-12-09
• METHYL OLIVETOLATEInactive2025-01-15
• SULINDACInactive2006-12-28

FDA compliance signals

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