HELSINN THERAPEUTICS US INC
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.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances HELSINN THERAPEUTICS US INC 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
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, 100 MG TABLETSActive2016-11-16
- ANAMORELIN HYDROCHLORIDE (API)Active2016-11-16
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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