Zydus Lifesciences Gets Tentative Approval for Sugammadex from USFDA

HQ Team

Sept 16, 2022: Zydus Lifesciences Ltd (formerly known as Cadila Healthcare Limited) announced Friday that its U.S. subsidiary, Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the US Food and Drug Administration (USFDA) to market the generic version of its Sugammadex injection.

Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. The cautious approval is for Sugammadex Injection of strengths 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), single-dose vial, the company said in a regulatory filing.

Zydus said that the drug will be manufactured at the group’s injectables manufacturing facility at Jarod, India.

According to available data, the Sugammadex injection’s annual sales stood at $772 million in the United States.

Zydus now has 323 approvals from the regulatory body.

Zydus recently also acquired rights to market MonoFerric (iron isomaltoside) injections in India and Nepal from Pharmacosmos, a Denmark-based company.

MonoFerric injection is a rapid, single-dose intravenous therapy used to treat iron deficiency in adult patients who do not respond to oral doses. 

 MonoFerric is available in over 30 countries, including the US and Europe, and over 28 million doses have been administered since launch, says the company press release.

Zydus Lifesciences is a global life sciences company with a strong presence across the spectrum of the pharmaceutical value chain. It has products ranging from formulations to active pharmaceutical ingredients and animal healthcare products to wellness products. Zydus provides comprehensive and complete healthcare solutions. 

 Zydus Lifesciences achieved compound earnings per share growth of 9.1% per year in the last three years. The company’s consolidated net profit fell 11.7% to Rs 518.3 crore on a 1.8% increase in total income from operations to Rs 4,072.7 crore in Q1 FY23 over Q1 FY22.

Shares of Zydus Lifesciences were down 1.89% to Rs 364.05 on the BSE.

If interested, get a detailed peep into Zydus Lifesciences’s earnings and revenue performances here.