Zydus receives tentative approval from USFDA for Enzalutamide Tablets
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus’ injectable portfolio for the US market
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development
ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA
Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure
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