News | July 21, 2021
EMA grants ODD to Saroglitazar Mg
Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC
Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC
The company has already embarked upon significant expansion in Turkey
The companies anticipate clinical studies to begin in August, subject to regulatory approvals
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
The five pharma companies have entered into a collaboration agreement, wherein the parties will jointly sponsor, supervise and monitor the clinical trial in India
The company has now received the renewed GMP (Good Manufacturing Practices) certificate thereby confirming the successful closure of the inspection
The expanded laboratories and manufacturing facilities at Nansha are expected to come online between Q1 2022 and Q3 2022
Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell certain generic lenalidomide capsules
Entered into a manufacturing partnership with Ocugen, Inc. for manufacturing of COVID-19 vaccine COVAXIN for the US and Canadian markets
The company expects to see steady performance led by new launches and gradual normalization post the scale-up in vaccination
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