The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market
This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years
Parecoxib Sodium is the first parenteral selective COX-2 inhibitor available for clinical use in pain management
Tiotropium (as bromide monohydrate) 18 micrograms powder for inhalation in capsule
The company plans to expand its portfolio in regulated markets aggressively
The products will be manufactured in Goa India and marketed & distributed in Australian markets
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
Aims to achieve CDMO sales of US$ 400 million by 2028
The recent inspection covered both cGMP and PAI processes
This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.
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