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Zydus Lifesciences has received final assent from the USFDA to manufacture and market methylene blue Injection. The company’s methylene blue injection — 10mg/2ml and 50mg/5ml — is the generic version of the reference listed drug (RLD) ProvayBlue Injection.
Zydus said in its regulatory filing that the injection is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. The company also observed that it had an annual sale of approximately $73.4 million in the US.
The company’s stock inched up by 0.61 per cent on the NSE, trading at ₹637.90 at 2:25 pm.
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