Foreign-Trade Zone (FTZ) 189, Notification of Proposed Production Activity; Grand River Aseptic Manufacturing; (Pharmaceutical Products); Grand Rapids and Caledonia, Michigan

Kent-Ottawa-Muskegon Foreign-Trade Zone Authority, grantee of FTZ 189, submitted a notification of proposed production activity to the FTZ Board (the Board) on behalf of Grand River Aseptic Manufacturing (GRAM) for GRAM's facilities in Grand Rapids and Caledonia, Michigan within FTZ 189. The notification conforming to the requirements of the Board's regulations (15 CFR 400.22) was received on May 21, 2025.

Pursuant to 15 CFR 400.14(b), FTZ production activity would be limited to the specific foreign-status material(s)/component(s) and specific finished product(s) described in the submitted notification (summarized below) and subsequently authorized by the Board. The benefits that may stem from conducting production activity under FTZ procedures are explained in the background section of the Board's website—accessible via www.trade.gov/​ftz.

The proposed finished product is nivolumab (duty-free).

The proposed foreign-status material is atigotatug—nivolumab (active pharmaceutical ingredient) (duty-free).

Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary and sent to: [email protected]. The closing period for their receipt is July 14, 2025.

A copy of the notification will be available for public inspection in the “Online FTZ Information System” section of the Board's website.

For further information, contact Christopher Wedderburn at [email protected].