Federal Register #B-122-2026

Proposed Drug Product Manufacturing by Eli Lilly at FTZ 93, Durham, NC

The Department of Commerce's Foreign-Trade Zones Board is reviewing a notification from Eli Lilly and Company for proposed production activities at its Durham, North Carolina facility within FTZ 93. - Government Buyer: - Department of Commerce - Foreign-Trade Zones Board - International Trade Administration - OEM Highlight: - Eli Lilly and Company is the sole Original Equipment Manufacturer (OEM) referenced - Products/Services Requested: - Manufacture of various drug products, including: - Incretin-based therapies for blood glucose and weight management - CGRP monoclonal antibodies for migraine prevention - IL-17A monoclonal antibodies for chronic inflammatory conditions - Multi-incretin therapies for metabolic management - IL-13 and IL-23 targeted therapies for atopic dermatitis and inflammatory bowel disease - Amylin receptor-targeted therapies for weight management - Amyloid-targeted therapies for early Alzheimer's disease - Dosage forms include filled syringes, vials, delivery pens, and semi-finished syringes - Use of foreign-status materials and components: - Drug substances - Medicine delivery devices and parts (Cap Cartridge Holder, Dry Side Subassembly, Damping Cup, RNS Puller, Base Cap) - Medicine delivery device needles - Glass vials - Syringes - Unique/Notable Requirements: - Some materials and components are subject to duties under section 232 of the Trade Expansion Act of 1962 or section 301 of the Trade Act of 1974, depending on country of origin - These materials must be admitted to FTZs in privileged foreign status as per 19 CFR 146.41 - Public comments are invited on the proposed production activity - Additional Information: - Notification also references antidumping duty administrative review for superabsorbent polymers from Korea, with zero dumping margin for LG Chem, Ltd.

Description

The Foreign-Trade Zones Board has received a notification from Eli Lilly and Company regarding proposed production activities within FTZ 93 located in Durham, North Carolina. The activities involve the production of various drug products including incretin-based therapies, monoclonal antibodies, and other targeted therapies in dosage/packaged forms such as filled syringes, vials, or delivery pens. The notice details the specific finished products and foreign-status materials/components involved, some of which are subject to duties under trade laws. Public comments are invited on the proposed production activity.

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