NEW HORIZON PHARMA US INC

Overview

NEW HORIZON PHARMA US INC is an active pharmaceutical ingredient (API) supplier with 8 active FDA Type II Drug Master Files, covering ENCLOMIPHENE CITRATE; GEPIRONE HYDROCHLORIDE; INOSITOL USP-NF; MINOXIDIL USP; NICOTINAMIDE ADENINE DINUCLEOTIDE; PITOLISANT HYDROCHLORIDE IN-HOUSE.

API / Drug Master Files

NEW HORIZON PHARMA US INC holds 8 active (8 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.

• GEPIRONE HYDROCHLORIDEActive2025-12-27
• ENCLOMIPHENE CITRATEActive2025-10-17
• SODIUM PHENYLBUTYRATE USPActive2025-09-30
• INOSITOL USP-NFActive2025-09-08
• MINOXIDIL USPActive2025-05-25
• NICOTINAMIDE ADENINE DINUCLEOTIDEActive2025-04-06
• SALSALATE USPActive2025-02-04
• PITOLISANT HYDROCHLORIDE IN-HOUSEActive2024-04-01

FDA compliance signals

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