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great success . “ As of September 2016 , 19 of the 26 meningitis belt countries have rolled out MenAfriVac ®. The remaining countries should introduce the vaccine this year . By 2020 , the vaccine is expected to protect more than 400 million people — preventing 1 million cases of meningitis A ; 150,000 deaths ; and 250,000 cases of severe disability .”
USFDA to lift import alert on Sun Pharma ’ s Mohali facility
Sun Pharma in a statement issued on March 14 , 2017 , mentioned that it was informed by the US FDA a day earlier , about the lifting of the ‘ Import Alert ’ imposed on the Mohali ( Punjab ) manufacturing facility and remove the facility from the Official Action Initiated ( OAI ) status . This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market , subject to normal US FDA regulatory requirements .
The Mohali facility was inherited by Sun Pharma as part of its acquisition of Ranbaxy Laboratories in 2015 . The US FDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy ’ s Consent Decree of Permanent Injunction . Certain conditions of the consent decree will continue to be applicable to the Mohali facility .
This development as per Sun Pharma , illustrates its commitment to work closely with the US FDA and strive for 100 % cGMP compliance at its manufacturing facilities .
Hilleman Lab partners with NICED , ICMR to develop Shigella vaccine
Hilleman Laboratories , a joint-venture partnership between MSD and Wellcome Trust , has signed a Memorandum of Understanding ( MoU ) with the National Institute of Cholera and Enteric Diseases ( NICED ), an ICMR organization for further development and commercialization of the Shigella vaccines and other enteric vaccines for diarrheal diseases . This agreement was signed as an effort of Hilleman ’ s mission to make affordable vaccines for the developing world population .
“ Shigella is the second most fatal organism after Rotavirus that causes severe diarrhea in children with no approved vaccine available at this time . We are pleased at this opportunity to collaborate with NICED and jointly develop Shigella vaccine for a disease whose basic pathology is not yet
72 BioVoiceNews | April 2017