News | August 27, 2021
Marksans announces US FDA approval for Acetaminophen Extended- Release tablets
The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India
The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India
The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually
The company to receive upfront and milestone payments, in addition to royalties
The software enables real-time communication between patients, caregivers, physicians, and pharmacists and each cartridge in the device has a unique, traceable serial number registered to the patient
The profits were bolstered by the Boehringer Ingelheim MEK program income
India is dependent upon China and other countries for a lot of Key Starting Materials (KSM) for their bulk drug needs.
The company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.
The company expects to see steady performance led by new launches and gradual normalization post the scale-up in vaccination
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
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