Federal Register #2026-14692

Proposed Peptide Manufacturing Activity by PolyPeptide Laboratories Inc. under FTZ 202

This notice from the Foreign-Trade Zones Board announces a proposed production activity at PolyPeptide Laboratories Inc. in Torrance, California. - Government Buyer: - U.S. Department of Commerce, Foreign-Trade Zones Board - OEMs and Vendors: - PolyPeptide Laboratories Inc. (highlighted as the primary manufacturer) - Products/Services Requested: - Manufacture of peptides, including: - Liraglutide (sodium) - Nectin - Linaclotide - Use of various foreign-status materials and components, such as: - Fmoc-linker, phenylalanine, threonine, Fmoc-Lys(Mtt)-OH, histidine, Fmoc-Phe-Thr(Psi(Me,Me)pro)-OH, Fmoc-Leu-Ser(Psi(Me,Me)pro)-OH, pGlu-OH, diisopropylcarbodiimide, ethyl cyanoglyoxylate-2-oxime, tryptophan, Boc-His(Trt)-Ala-Glu(OtBu)-Gly-OH, arginine, Fmoc-His(Trt)-OH, D-valine, glutamine, glycine, valine, Fmoc-Lys(Boc)-OH, cysteine, methionine, aspartic acid, alanine, isoleucine, O(6)-NPE-N(2)iBu protected G PMO Monomer, Fmoc-Glu(OtBu)-OH.H20, MBH-Br Resin, Rink Amide-MBHA Resin, 2CTC Resin - Unique or Notable Requirements: - Finished peptides are duty-free; input materials have duty rates from duty-free up to 6.5% - Some materials are subject to special trade act provisions (sections 122, 232, and 301), requiring privileged foreign status depending on country of origin - Public comment is invited on the proposed activity

Description

Notification of proposed production activity at PolyPeptide Laboratories Inc. in Torrance, California, under FTZ 202. The production activity involves the use of specific foreign-status materials and components to manufacture peptides including liraglutide, sodium; nectin; and linaclotide. The materials have varying duty rates and some are subject to special trade act provisions. Public comments are invited until August 31, 2026.

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