NEWCHEM SPA

Overview

NEWCHEM SPA is an active pharmaceutical ingredient (API) supplier with 19 active FDA Type II Drug Master Files, covering ALCLOMETASONE DIPROPIONATE MICRONIZED; BIMATOPROST; BUDESONIDE MICRONIZED; CICLESONIDE; CLOBETASOL PROPIONATE; DEFLAZACORT.

Core services & business areas

Active pharmaceutical ingredients supplied

Substances NEWCHEM SPA is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

API / Drug Master Files

NEWCHEM SPA holds 19 active (24 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.

• ALCLOMETASONE DIPROPIONATE MICRONIZEDActive2026-02-17
• CLOBETASOL PROPIONATEActive2025-12-17
• LATANOPROSTENE BUNODActive2025-11-18
• MOMETASONE FUROATE MONOHYDRATE MICRONISEDActive2025-10-05
• CICLESONIDEActive2025-08-05
• DIENOGEST MICRONIZED AND NON-MICRONIZEDActive2025-07-08
• BIMATOPROSTActive2025-06-27
• ESTETROL MONOHYDRATEActive2025-06-26
• FLUTICASONE FUROATEActive2025-06-13
• LATANOPROSTActive2024-05-23
• DEFLAZACORTActive2023-05-19
• DROSPIRENONE EP/USPActive2022-01-26
• ULIPRISTAL ACETATEActive2017-11-17
• BUDESONIDE MICRONIZEDActive2011-08-22
• TRIAMCINOLONE ACETONIDE MICRONIZEDActive2011-01-07

Showing 15 of 24 Drug Master Files.

FDA compliance signals

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