ROQUETTE FRERES

Overview

ROQUETTE FRERES is an active pharmaceutical ingredient (API) supplier with 6 active FDA Type II Drug Master Files, covering DEXTROSE MONOHYDRATE USP GRADE (LYCADEX® PF); HYDROXYPROPYL BETADEX; MANNITOL USP GRADE (PEARLITOL PF); ROQUETTE® POLYDEXTRIN (Icodextrin); SODIUM GLUCONATE; SORBITOL POWDER PYROGEN FREE.

Core services & business areas

Active pharmaceutical ingredients supplied

Substances ROQUETTE FRERES 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

ROQUETTE FRERES holds 6 active (10 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.

• ROQUETTE® POLYDEXTRIN (Icodextrin)Active2022-12-20
• SORBITOL POWDER PYROGEN FREEActive2020-06-09
• SODIUM GLUCONATEActive2020-01-15
• HYDROXYPROPYL BETADEXActive2016-08-29
• MANNITOL USP GRADE (PEARLITOL PF)Active1998-02-26
• DEXTROSE MONOHYDRATE USP GRADE (LYCADEX® PF)Active1982-10-27
• MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN LESTREM,FRANCE.Inactive1994-12-05
• MANNITOL GRANULAR G.G.Inactive1986-10-29
• MANNITOLInactive1984-06-29
• SODIUM STARCH GLYOLATE LOW PHInactive1984-02-08

FDA compliance signals

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