HELSINN THERAPEUTICS US INC

Pazzallo, Ticino, Switzerland helsinn.com

Overview

HELSINN THERAPEUTICS US INC is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering ANAMORELIN HYDROCHLORIDE (API); ANAMORELIN HYDROCHLORIDE, 100 MG TABLETS.

API / Drug Master Files

HELSINN THERAPEUTICS US INC holds 2 active (2 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.

  • ANAMORELIN HYDROCHLORIDE (API)Active2016-11-16
  • ANAMORELIN HYDROCHLORIDE, 100 MG TABLETSActive2016-11-16

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to HELSINN THERAPEUTICS US INC in our records. PharmaTek screens the full directory against live FDA enforcement data.

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