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The US FDA has placed Sun Pharma’s Halol unit under ‘import alert’ , concluding that all future shipments of the products manufactured from this facility will be deemed unfit to enter the US market until it becomes compliant with the cGMP standards.
The Gujarat Food and Drug Control Administration (FDCA) notified that it had issued a license to set up 784 new manufacturing units during the last year in the State. Gujarat has 6.9 lakh product licenses and has issued 5,203 manufacturing licenses till date.
A few months ago Takeda’s Dengue fever vaccine received approval for use in Indonesia and recently has been approved by the EU to market it across Europe. The European Commission endorsed ‘Qdenga’ to protect people aged 4 and older from dengue fever.
‘Touchlight’ , a biotechnology firm excelling in producing enzymatic DNA for genetic medicines, announced its development and supply agreement with France-based ‘Odimma Therapeutics’ to develop personalized Cancer therapy.
Vertex Pharmaceuticals is all set to enter into a collaboration deal with Entrada Therapeutics to develop intracellular Endosomal Escape Vehicle (EEV) therapeutics. With the inlicensing agreement, Entrada will receive a whopping cash payment of $224 million and an equity investment of $26 million.
On Thursday, Lupin limited declared the appointment of Spiro Gavaris as the president, of US Generics Business. He will now be responsible for implementing strategies, taking decisions, and growth of Lupin’s generic business in the US.
Visiox Pharma, a privately funded Biopharmaceutical company dealing with the development and commercialization of Ophthalmic products, announced the acceptance of their NDA for their new Glaucoma drug by the US FDA.
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