Shares of Zydus Lifesciences, on 6 December, announced that it had received final approval from the USFDA (United States Food and Drug Administration) for manufacturing and marketing Methylene Blue Injection, available in 10mg/2ml and 50mg/5ml variants.

The Methylene Blue Injection is the generic equivalent to the Reference Listed Drug (RLD) ProvayBlue Injection.

Methylene Blue Injection is an oxidation-reduction agent that is used for treating paediatric and adult patients with acquired methemoglobinemia.

The product had an annual sales of around $73.4 million in the US as of October 2023.

Dr Sharvil Patel, Managing Director of Zydus Lifesciences Limited, said, “Zydus is pleased to introduce Methylene Blue Injection, 10mg/2ml and 50mg/5ml in the US, continuing our commitment to supply affordable complex generic medications to patients in need and strengthening the US supply chain of care.”

He added, “Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product. The efforts of our team who have worked on the development, filing and manufacturing of Methylene Blue Injection reflects our ongoing commitment to bringing complex generic products accessible to patients who need them the most.”

In its quarterly report for July-September, the company reported a 53.2% year-on-year growth in its consolidated net profit to Rs 800.7 crore for the quarter.