Drug Approval | July 22, 2024
Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
Cyclosporine Ophthalmic Nanoemulsion is a preservative-free Nanoemulsion that has been approved in South Korea, Peru and several countries in the Middle East for treatment of dry eye syndrome
Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)
Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
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€ 6.6 million investment at Nantong site expands production capabilities for cell culture media
Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension
Protein research is key to advancing our understanding of human biology and delivering on the promise of precision medicine
The approved ANDA is therapeutically equivalent to the reference listed drug product
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