SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD

Overview

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD is an active pharmaceutical ingredient (API) supplier with 7 active FDA Type II Drug Master Files, covering BETAMETHASONE DIPROPIONATE; CLOBETASOL PROPIONATE; DEXAMETHASONE SODIUM PHOSPHATE; EXEMESTANE; HALOBETASOL PROPIONATE; HYDROCORTISONE VALERATE USP.

API / Drug Master Files

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD holds 7 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.

• HYDROCORTISONE VALERATE USPActive2017-02-01
• HALOBETASOL PROPIONATEActive2016-08-22
• MOMETASONE FUROATEActive2012-06-01
• EXEMESTANEActive2011-07-25
• BETAMETHASONE DIPROPIONATEActive2010-10-12
• DEXAMETHASONE SODIUM PHOSPHATEActive2010-09-22
• CLOBETASOL PROPIONATEActive2010-07-23
• BETHAMETHASONE VALERATEInactive2013-06-03

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD in our records. PharmaTek screens the full directory against live FDA enforcement data.