Federal Register #B-45-2026

Pharmaceutical Manufacturing at FTZ 21 by Patheon API, Inc. (Meloxicam, Xeloda, Tamiflu)

The Department of Commerce, through the Foreign-Trade Zones Board, is reviewing a request for new pharmaceutical production at Patheon API, Inc.'s facility in Florence, South Carolina (FTZ 21). - Government Buyer: - Department of Commerce, Foreign-Trade Zones Board - OEMs and Vendors: - Patheon API, Inc. (primary OEM and facility operator) - Manufacturers of Meloxicam, Xeloda (Capecitabine), and Tamiflu (Oseltamivir Phosphate Shikimic Acid) - Products/Services Requested: - Manufacture of pharmaceutical products: - Meloxicam Spray Dried Intermediate - Capecitabine (Xeloda) - Oseltamivir Phosphate Shikimic Acid (Tamiflu) - Use of specific foreign-status materials/components: - Eeccetamidoazide Shikimic Acid - Aromatic crystalline acetylfuranoside - Nonaromatic crystalline acetylfuranoside - Sulphobutyl-ether-b cyclodextrin - Flucytosine - Meloxicam (as a component) - Unique/Notable Requirements: - Some materials/components are subject to duties under section 122 or section 301 of the Trade Act of 1974, depending on country of origin - Certain materials must be admitted to the Foreign-Trade Zone in privileged foreign status - The opportunity is open for public comment as part of the regulatory process - Place of Performance: - Patheon API, Inc. facility, Foreign-Trade Zone 21, Florence, South Carolina

Description

The Department of Commerce's Foreign-Trade Zones Board has announced a proposed production activity at Patheon API, Inc., located in Florence, South Carolina, within Foreign-Trade Zone 21. The activity involves the manufacturing of Meloxicam, Xeloda, and Tamiflu. The notification includes details about the specific foreign-status materials and finished products involved. Interested parties are invited to review the details and submit comments by June 22, 2026.

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