Foreign-Trade Zone (FTZ) 35; Authorization of Limited Production Activity; PPL Healthcare dba Piramal Pharma Solutions; (Cholesterol Medication); Philadelphia, Pennsylvania

On February 12, 2025, PPL Healthcare dba Piramal Pharma Solutions (Piramal) submitted a notification of proposed production activity to the FTZ Board for its facility within FTZ 35, in Philadelphia, Pennsylvania.

The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (90 FR 9887, February 19, 2025). On November 13, 2025, the applicant was notified of the FTZ Board's decision authorizing the production activity described in the notification on a limited basis, subject to the FTZ Act and the Board's regulations, including section 400.14, and further subject to a three-year limited authorization and to a requirement that if Piramal changes the supplier or country of origin of its active pharmaceutical ingredients, it must request and receive approval from the FTZ Board that this authorization is still in line with the public interest.