Dr Reddy’s Laboratories touched a day high of ₹1,182 after the company disclosed in an exchange filing that it received US FDA approval.

The approval marks the company’s entry into the US market with this particular product.

Rituximab is a lab-made antibody that targets B-cell cancers such as non-Hodgkin lymphoma and chronic lymphocytic leukaemia, and it’s also used for autoimmune diseases like rheumatoid arthritis.

Dr Reddy’s developed, manufactured, and filed for approval on this drug entirely in-house.

Before granting the approval, the FDA inspected Dr Reddy’s biologics manufacturing facility in Bachupally, on the outskirts of Hyderabad.

Passing that inspection matters because it shows regulators that the company can reliably produce complex biologic medicines to the standard the US market demands, not just simpler generic drugs.

Sridevi Khambhampaty, Global Head of Biologics at Dr Reddy’s, said the approval landing on the FDA’s goal date reflects the company’s ability to develop and manufacture complex biologic medicines for global markets.

This isn’t the drug’s first market. Dr Reddy’s version of rituximab is already sold in India, the European Union, the United Kingdom, and more than 25 emerging markets, and it holds marketing approval in Switzerland and Canada as well.

In the US specifically, the product will be commercialised exclusively by Fresenius Kabi under an existing partnership between the two companies.

By 14:40 PM on Monday, Dr Reddy’s shares were trading at ₹1,168.40, up 1.77% for the day.

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