Zydus Lifesciences shares were trading marginally above on 23 October after the company announced receiving approval from USFDA (the United States Food and Drug Administration) for its diabetic drug.

On 20 October, the company announced that it had received approval for its New Drug Application from USFDA for ZITUVIO tablets of 25mg, 50mg, and 100mg strength.

In its regulatory filing, the company said, “ZITUVIO contains active ingredient Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”

The drug has undergone rigorous quality testing for nitrosamines and potential genotoxic impurities that are required as per the current USFDA standards. The drug complies with the current USFDA standards of nitrosamines in sitagliptin-containing products.

Dr Sharvil Patel, managing director of Zydus Lifesciences Limited, said that ZITUVIO approval builds on the company’s long-term commitment to offering healthcare professionals a new affordable treatment option in connection to diabetes management.

Earlier last week, the company had appointed Dr Punit Patel as the president and CEO (Chief Executive Officer) for America. Dr Patel will be responsible for the business operations of all the company’s entities in North America that, would cover injectables and specialty business, generics, rare and orphan disease portfolio, and also future forays into novel therapeutics.

Dr Punit Patel, CEO of Zydus Pharmaceuticals – America, said, “We are pleased to be able to receive such a milestone approval for Zydus. Through our industry leading capabilities, we pride ourselves in finding innovative ways to bring value to the healthcare systems by providing affordable medicines for our patients. We look forward to bringing additional innovative products in the future that align with our purpose to empower patients to live healthier and more fulfilled lives.”

At 10:46 am, the shares of Zydus Lifesciences were trading 0.26% below at Rs 577.40 on NSE.