Search Results for keywords:"pharmaceutical production"

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Search Results: keywords:"pharmaceutical production"

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  • 2024-31702 — Foreign-Trade Zone (FTZ) 49, Notification of Proposed Production Activity; Sanofi US Services Inc.; (Pharmaceutical Products); Ridgefield, New Jersey
    Type:Notice
    Citation:90 FR 596
    Reading Time:about a minute or two

    Sanofi US Services Inc. has asked the Foreign-Trade Zones Board for permission to start production of pharmaceutical products at its facilities in Ridgefield, New Jersey, within FTZ 49. Specifically, they plan to produce Beyfortus® (Nirsevimab), a vaccine that will be duty-free. The materials needed for this production also include the duty-free Beyfortus® monoclonal antibody active ingredient. The public is invited to comment on this proposal by February 18, 2025, by sending an email to the Board's Executive Secretary.

    Simple Explanation

    Sanofi wants permission to make a special vaccine in New Jersey where they don't have to pay extra taxes, and they are asking people to email their thoughts about this by February 18, 2025.

  • 2025-00543 — Foreign-Trade Zone (FTZ) 49, Notification of Proposed Production Activity; Merck, Sharp & Dohme LLC; (Pharmaceutical Products for Research and Development); Rahway, New Jersey
    Type:Notice
    Citation:90 FR 3173
    Reading Time:about a minute or two

    Merck, Sharp & Dohme LLC has informed the Foreign-Trade Zones (FTZ) Board about proposed production activities at their Rahway, New Jersey, facility, which is part of Subzone 49Y. The proposal includes producing drugs for metabolic and immunological disorders using specific foreign-sourced materials. Interested parties can submit their comments to the FTZ Board by February 24, 2025. More details and the notification can be accessed on the Board's website.

    Simple Explanation

    Merck, Sharp & Dohme wants to make new medicines for certain illnesses in their New Jersey factory using some materials from other countries, and the government is asking anyone who is interested to tell them what they think about this plan by February 24, 2025.

  • 2025-06283 — Foreign-Trade Zone (FTZ) 49, Notification of Proposed Production Activity; Merck, Sharp & Dohme LLC; (Pharmaceutical Products for Research and Development); Rahway, New Jersey
    Type:Notice
    Citation:90 FR 15541
    Reading Time:about a minute or two

    Merck, Sharp & Dohme LLC has submitted a proposal to the Foreign-Trade Zones Board for a production activity in their Rahway, New Jersey facility, which is part of Foreign-Trade Zone 49. The proposal outlines plans to manufacture various pharmaceutical products, including drugs for infectious and neurologic diseases, oncology, immunotherapy, and cardiovascular disease, using foreign materials. Some of these materials are subject to specific trade regulations depending on their country of origin. Public comments on the proposal are welcome until May 27, 2025, and those interested in more information can contact the Board or access documents on their website.

    Simple Explanation

    Merck, Sharp & Dohme LLC wants to make medicines in a special area in Rahway, New Jersey where they can get special rules to help them bring in parts from other countries. They're asking for comments from people to tell what they think about this idea until May 27, 2025.

  • 2025-05115 — Foreign-Trade Zone (FTZ) 35; Authorization of Production Activity; PCI Pharma Services; (Pharmaceutical Products); Croydon and Philadelphia, Pennsylvania
    Type:Notice
    Citation:90 FR 13732
    Reading Time:less than a minute

    PCI Pharma Services submitted a proposal to the Foreign-Trade Zones (FTZ) Board on November 21, 2024, to begin production activities at their facilities in Croydon and Philadelphia, Pennsylvania, within FTZ Subzone 35L. This notification adhered to the FTZ Board's regulations, and the public had the opportunity to comment on it as announced in the Federal Register on November 29, 2024. On March 21, 2025, the FTZ Board decided that no further review was needed, authorizing the proposed production activities in accordance with FTZ regulations.

    Simple Explanation

    PCI Pharma Services wants to make medicines in two places in Pennsylvania, and a special group that helps with trade said it's okay for them to start doing this.