Drug Approval | April 28, 2024
Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal
The USFDA has issued 5 observations pursuant to the completion of audit
The USFDA has issued 5 observations pursuant to the completion of audit
The QC Lab is equipped with advanced instruments to ensure rigorous quality control across all manufacturing processes
Keimed is a leading wholesale pharma distribution with industry leading operating metrics
The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
Additional data in pregnant adults who are Virologically suppressed reinforce safety and tolerability profile of Biktarvy in broad range of people with HIV
The company will closely work with the USFDA to address and respond to the observations in an expeditious manner
Approval from Colombia's INVIMA will accelerate growth in Colombia, by registering our product and getting regular supplies
Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US
Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market
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