Ranbaxy Laboratories has hired Rudy Giuliani, the former mayor of New York, to assist it in overcoming its recent issues with the US Food and Drug Administration (FDA).
Giuliani and Giuliani Partners will provide Ranbaxy with advice and review the good manufacturing practice (GMP) compliance issues that were raised by the FDA.
The FDA has prohibited the import of 30 finished drug products manufactured at two of Ranbaxy’s facilities in India.
Ranbaxy has said that the addition of Giuliani to its advisory team is an indication of its willingness to work cooperatively with the FDA to address the import ban.
It was also keen to reiterate that the FDA said all drugs manufactured by Ranbaxy have tested safe and effective with no adverse incidents reported.
China-based Simcere Pharmaceutical has promoted Jindong Zhou and Xiaojin Yin to the posts of executive vice president and senior vice president, respectively.
Zhou joined Simcere in 1994 and now has over twenty years of experience in the pharmaceutical industry. He was Simcere’s vice president of manufacturing prior to his promotion, in which capacity he oversaw several GMP compliant facilities.
In his new role his responsibilities will broaden to include sales and marketing and other executive office support.
Yin joined Simcere in 2000 and has worked in the company’s R&D department. Over this period he has been involved in the development of Bicun, Endu and many other pipeline products.
BioProcess Technology Consultants, a provider of technical and regulatory services to the biopharmaceutical industry, has appointed Alex Kanarek and Scott Fulton as senior consultants.
Kanarek has experience in large-scale manufacturing, regulatory compliance, and quality assurance and has previously worked as director of product development at Connaught Laboratories.
He is the author of numerous books and reports on regulatory compliance, including guides to GMP and good laboratory practice (GLP).
Fulton’s background is in large-scale purification technology, biomolecule analysis, economic modeling of biopharmaceutical manufacturing and transgenic production.
He has previously worked as vice president of program management at Genzyme Transgenics and has also held senior management positions at Amicon and PerSeptive Biosystems.