Drug Approval | July 08, 2022
Lupin’s Somerset manufacturing plant Receives EIR from US FDA
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
H Clinical is the leader in decentralized clinical trial support and home visits in Latin America
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S
This facility will produce higher efficacy products that enjoy greater acceptance and enhanced profit marginsg
An interim analysis of this data shows no significant safety issues and a 91% seroconversion rate at Day 56.
TAK-003 is currently undergoing regulatory review for potential licensure in both the European Union
Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine
The partners also aim to expand their work to Latin America for the first time
This is the first major brand refresh of CanSinoBIO since its inception in 2009
Launch of novel stent technology with 10-year safety and efficacy data adds further momentum to the company's global growth journey
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