ROLABO OUTSOURCING SL

Overview

ROLABO OUTSOURCING SL is an active pharmaceutical ingredient (API) supplier with 7 active FDA Type II Drug Master Files, covering ATROPINE SULFATE USP; ATROPINE USP; CANNABIDIOL; LORATADINE USP; PALONOSETRON HYDROCHLORIDE; SIROLIMUS INTERMEDIATE.

API / Drug Master Files

ROLABO OUTSOURCING SL holds 7 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.

• SIROLIMUS INTERMEDIATEActive2025-10-02
• CANNABIDIOLActive2024-12-03
• TETRABENAZINEActive2015-10-09
• ATROPINE USPActive2015-09-25
• ATROPINE SULFATE USPActive2015-05-25
• PALONOSETRON HYDROCHLORIDEActive2010-12-23
• LORATADINE USPActive1999-05-26
• DOLASETRON MESYLATEInactive2008-07-31
• ATOVAQUONE USPInactive2008-02-15
• TRANDOLAPRILInactive2005-11-08

FDA compliance signals

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