💊Indivior Inc. Seeks Registration for Importing Controlled Substances
Indivior Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More🚀DOJ Notice on Membership Changes in Rapid Response Partnership Vehicle
The Department of Justice's notice announces changes in the membership of the Rapid Response Partnership Vehicle (RRPV) under the National Cooperative Research and Production Act. New members have been added, while one has withdrawn. The notice emphasizes that no other changes in the group's activities or membership status were made, and future notifications are anticipated.
Learn More🏭EPA NESHAP for Pharmaceuticals Production Renewal Notice
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Pharmaceuticals Production (EPA ICR Number 1781.10, OMB Control Number 2060-0358) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through February 28, 2025. Public comments were previously requested via the Federal Register on May 18, 2023 during a 60-day comment period. This notice allows for an additional 30 days for public comments.
Learn More💊Merck Authorized for Production in Foreign-Trade Zone 49
The Foreign-Trade Zones Board has authorized Merck, Sharp & Dohme LLC to conduct production activities for pharmaceutical products within FTZ 49 in Rahway, New Jersey. This decision follows a review process, indicating compliance with federal regulations and allowing for enhanced operational support in the pharmaceutical sector.
Learn More⚖️USITC Investigation 337-TA-1352 on Trade Secrets in Pharma
Notice is hereby given that the U.S. International Trade Commission ("Commission") has determined to review a final initial determination ("FID") issued by the presiding Chief Administrative Law Judge ("Chief ALJ"), finding a violation of section 337 of the Tariff Act of 1930, as amended. The Commission requests written submissions from the parties, interested government agencies, and other interested persons on the issues of remedy, the public interest, and bonding, under the schedule set forth below.
Learn More💊Foreign-Trade Zone Notice for Piramal Pharma Solutions Production
The Department of Commerce announces Piramal Pharma Solutions' proposed production activity for cholesterol medication in Foreign-Trade Zone 35. The notification details the specific duty-free products and invites public comments, providing insight into production limitations and opportunities for businesses involved in pharmaceutical manufacturing.
Learn More💊Scottsdale Research Institute Seeks Registration for Controlled Substances
Scottsdale Research Institute has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More💊Janssen Pharmaceuticals' Application for Controlled Substances Registration
Janssen Pharmaceuticals, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More💊Mylan Pharmaceuticals Applies for Controlled Substances Import Registration
Mylan Pharmaceuticals, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More💊Lonza Tampa
Lonza Tampa, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
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