One batch has 11.4 million units of Naproxen tablets out of which 0.9 million units that were released into the market were recalled
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.
Zydus’ Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (Sitagliptin Phosphate)
The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India
The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India
Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older
The approval allows it to market its products in the country
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The antiviral technology involves the presence of active positive charges on the fabric, as binding sites for viruses and on contact with the fabric, virus cells that are negatively charged are neutralised, leading to the rapid destruction of their glycoprotein layers and the release of non-infectious ribonucleic acid (RNA)
The company is eligible for 12 months exclusivity from launch
OptumRx to make Pear’s three commercial Prescription Digital Therapeutics accessible to patients with Optum formulary access.
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