IBA Molecular North America, a radiopharmaceuticals company, announced that it has received Food and Drug Administration approval of abbreviated new drug applications for Fludeoxyglucose F-18 Injection, USP and Sodium Fluoride F-18 Injection, USP.
The company has also been busy upgrading its radiopharmaceutical facilities, transitioning its manufacturing and distribution network so it complies with 21 CFR Part 212 CGMP requirements.
Ken Smithmier, president and CEO of IBA Molecular North America, said these changes are all part of the company’s plan to push forward as a key player in the radiopharmaceuticals industry.
“For IBA, this transformation and the FDA approvals are much more than just meeting current regulations,” Smithmier said in a statement. “It is our pathway to the future of molecular imaging. We elected to put in place equipment and procedures that meet the very rigorous requirements (EC GMP standards) of our worldwide institutional and biotechnology associates, making IBA the premier partner in developing and introducing new, targeted radiopharmaceutical products.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.