RN LABORATORIES EUROPE BV

Overview

RN LABORATORIES EUROPE BV is an active pharmaceutical ingredient (API) supplier with 7 active FDA Type II Drug Master Files, covering CHLORHEXIDINE ACETATE ( 1,1-HEXAMETHYLENEBIS[5-(P-CHLOROPHENYL)BIGUANIDE] DIACETATE); CHLORHEXIDINE BASE (1,1'-HEXAMETHYLENEBIS[5-(4-CHLOROPHENYL) BIGUANIDE]); CHLORHEXIDINE HYDROCHLORIDE USP (2,4,11,13-TETRAAZATETRADECANEDIIMIDAMIDE, N,N”-BIS(4- CHLOROPHENYL)-3,12-DIIMINO-,DIHYDROCHLORIDE; 1,1’-HEXAMETHYLENEBIS[5-(PCHLOROPHENYL) BIGUANIDE]DIHYDROCHLORIDE); CLOBETASOL PROPIONATE USP (21-CHLORO-9-FLUORO-11, 17-DIHYDROXY-16-METHYLPREGNA-1,4-DIENE3,20-DIONE 17-PROPIONATE); N-octyl-1-[10-(4-octyliminopyridin-1-yl) decyl] pyridin-4-imine dihydrochloride (Octenidine Dihydrochloride); POVIDONE-IODINE USP (1-VINYL-2-PYRROLIDINONE POLYMER, COMPOUND WITH IODINE).

API / Drug Master Files

RN LABORATORIES EUROPE BV holds 7 active (7 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.

• CLOBETASOL PROPIONATE USP (21-CHLORO-9-FLUORO-11, 17-DIHYDROXY-16-METHYLPREGNA-1,4-DIENE3,20-DIONE 17-PROPIONATE)Active2020-02-11
• STRONG CETRIMIDE 40% SOLUTION BP (HEXADECY(TRIMETHYL) AZANIUM BROMIDE (40% SOLUTION)Active2020-02-11
• CHLORHEXIDINE HYDROCHLORIDE USP (2,4,11,13-TETRAAZATETRADECANEDIIMIDAMIDE, N,N”-BIS(4- CHLOROPHENYL)-3,12-DIIMINO-,DIHYDROCHLORIDE; 1,1’-HEXAMETHYLENEBIS[5-(PCHLOROPHENYL) BIGUANIDE]DIHYDROCHLORIDE)Active2020-02-03
• CHLORHEXIDINE BASE (1,1'-HEXAMETHYLENEBIS[5-(4-CHLOROPHENYL) BIGUANIDE])Active2020-02-03
• POVIDONE-IODINE USP (1-VINYL-2-PYRROLIDINONE POLYMER, COMPOUND WITH IODINE)Active2020-02-03
• CHLORHEXIDINE ACETATE ( 1,1-HEXAMETHYLENEBIS[5-(P-CHLOROPHENYL)BIGUANIDE] DIACETATE)Active2020-02-03
• N-octyl-1-[10-(4-octyliminopyridin-1-yl) decyl] pyridin-4-imine dihydrochloride (Octenidine Dihydrochloride)Active2019-12-11

FDA compliance signals

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