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N363467 · 2026-08-17 — RE: The tariff classification of ZIEXTENZO® (pegfilgrastim-bmez) Injection in dosage form, from Austria
ZIEXTENZO (pegfilgrastim-bmez), imported in 6 mg/0.6 mL prefilled syringes, is a leukocyte growth factor biosimilar to Neulasta®. It is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It is also indicated to increase survival in adults and pediatric patients aged newborn and older acutely exposed to myelosuppressive doses of radiation. The…
N350948 · 2025-12-18 — The tariff classification of HEC88473 Drug Product (also known as APL-18881) in dosage form, from China
We apologize for the delay as the information was submitted to our laboratory for analysis. HEC88473 (also known as APL-18881) is a biological bi-specific protein targeting glucagon-like peptide-1 (GLP-1) and fibroblast growth factors 21 (FGF21). It is being developed for the treatment of non-alcoholic steatohepatitis (NASH) and Alcohol Use Disorder (AUD). In your letter, you stated the HEC88473 drug product will be imported in 15 mg, 30 mg and 45 mg pre-filled syringes for subcutaneous administration in clinical trials. According to our laboratory, HEC88473 is a modified immunological…
N331005 · 2023-03-07 — The tariff classification of clinical trial kits from the United States
Both products will be imported from Ireland. The first product, MK-5592 clinical trial kit contains Noxafil, a brand name antifungal medication containing Posaconazole, as the active pharmaceutical ingredient (API). The MK-5592 clinical trial kit contains the following items: 1) 300 mg PFS Sachet of Posaconazole (CAS-171228-49-2) 2) Ora-Blend SF 3) 28 mm Press In Bottle Adapter Wrapped 4) Oraldisp 3 mL Non-Ster Notch Green Plunge 5) Oral Disp 10 mL Non-Ster Blue Plunge 6) Cup Round 7/8 oz Nonsterile Hingelid The second product, MK-7962 clinical trial kit contains the API, Sotatercept, which…
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