Skip to Content


Foreign-Trade Zone (FTZ) 7-Mayaguez, Puerto Rico; Notification of Proposed Production Activity; Romark Global Pharma, LLC; Subzone 7P; Manatí, Puerto Rico (Pharmaceuticals)

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

Romark Global Pharma, LLC (Romark), operator of Subzone 7P, submitted a notification of proposed production activity to the FTZ Board for its facility within Subzone 7P, in Manatí, Puerto Rico. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on February 6, 2017.

The Romark facility, currently under construction, will be used to produce finished pharmaceutical products and active ingredients. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

Production under FTZ procedures could exempt Romark from customs duty payments on the foreign-status components used in export production. On its domestic sales, Romark would be able to choose the duty rates during customs entry procedures that apply to Alinia® (nitazoxanide) tablets and oral suspension, nitazoxanide controlled release bilayer tablets, and nitazoxanide (active pharmaceutical ingredient) (duty rates—free and 6.5%) for the foreign-status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

The components and materials sourced from abroad include: Croscarmellose sodium; microcrystalline cellulose; plastic bottles; container labels; glass bottles; plastic caps; paper board cartons; colloidal silicon dioxide; cotton coil packaging; desiccant bags; dibasic calcium phosphate; hydroxypropyl cellulose; hydroxypropylmethylcellulose; hypromellose; product information paper inserts; magnesium stearate; pregelatinized corn starch; anhydrous citric acid; corn starch; strawberry flavoring with alcohol; sodium carboxymethylcellulose; nitazoxanide; sodium benzoate; sodium citrate dihydrate; sodium starch glycolate; talc; purified water; and, xanthan gum (duty rates range from free to 6.5%).

Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is April 10, 2017.

A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via​ftz.

For further information, contact Diane Finver at or (202) 482-1367.

Start Signature

Dated: February 21, 2017.

Andrew McGilvray,

Executive Secretary.

End Signature End Preamble

[FR Doc. 2017-03777 Filed 2-24-17; 8:45 am]