Federal Register #2026-10046

Proposed Production of Opdualag Immunotherapy Drug at FTZ 214, Greenville, NC

This notice announces proposed production activity at Patheon Manufacturing Services LLC within Foreign-Trade Zone (FTZ) 214 in Greenville, North Carolina. - Government Buyer: - Department of Commerce, Foreign-Trade Zones Board - OEMs and Vendors: - Patheon Manufacturing Services LLC (production facility) - Relatlimab and Nivolumab (active pharmaceutical ingredients, OEMs not explicitly named but are key components) - Products/Services Requested: - Production of Opdualag, consisting of pre-filled syringes containing Relatlimab and Nivolumab in aqueous solution - No specific part numbers or quantities provided - Unique or Notable Requirements: - Both Relatlimab and Nivolumab are foreign-status materials used in immunotherapy treatments - All finished products and most materials are duty-free; some materials may be subject to section 301 duties depending on country of origin - FTZ production activity is limited to the described materials and products - Public comments are invited regarding this proposed activity - Place of Performance: - Patheon Manufacturing Services LLC, FTZ 214, Greenville, North Carolina

Description

This notice pertains to the proposed production activity at Patheon Manufacturing Services LLC within FTZ 214 in Greenville, North Carolina. The proposed finished product is Opdualag, pre-filled syringes containing Relatlimab and Nivolumab in aqueous solution, which are duty-free. The foreign-status materials/components include Relatlimab and Nivolumab, both aqueous solutions used in immunotherapy treatments, also duty-free. Certain materials/components may be subject to duties under section 301 of the Trade Act of 1974 depending on the country of origin. Public comments are invited until June 29, 2026.

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