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.

Core services & business areas

Active pharmaceutical ingredients supplied

Substances ROLABO OUTSOURCING SL 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

ROLABO OUTSOURCING SL holds 8 active (11 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.

• ZAVEGEPANT HYDROCHLORIDEActive2026-05-21
• 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.