Swedish Orphan Biovitrum AB

Overview

Swedish Orphan Biovitrum AB, commonly known as Sobi, is a biopharmaceutical company headquartered in Sweden. The company specializes in rare diseases and is dedicated to developing and delivering innovative therapies for patients with high unmet medical needs around the globe.

Therapeutic areas

API / Drug Master Files

Swedish Orphan Biovitrum AB holds 1 active (1 total) FDA Type II Drug Master File — 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.

• SEL-110.36 BIODEGRADABLE NANOPARTICLE CONTAINING RAPAMYCINActive2020-08-19

FDA compliance signals

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