Orchid Pharma to launch Enmetazobactam drug in the US in the next couple of quarters
Chennai-based pharma company, Orchid Pharma Ltd, announced on Friday that it will be launching its Enmetazobactam drug in the US market within the next couple of quarters. The company has received approval from the USFDA for Enmetazobactam, a Beta Lactamase Inhibitor. This development has led to a surge in the company’s shares at the BSE.
The USFDA approval for Enmetazobactam is a significant milestone for Orchid Pharma as it paves the way for the introduction of the drug in the world’s largest pharmaceutical market. The company expects to launch the product within the next couple of quarters, following the recent recommendation for approval by the European Medicines Agency (EMA).
According to the company, the New Drug Approval (NDA) allows the use of Exblifep (Cefepime and Enmetazobactam) as an injection for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis caused by specific microorganisms.
Manish Dhanuka, Managing Director of Orchid Pharma, expressed his satisfaction with the USFDA approval, stating, “While the EMA recommendation for grant of marketing authorisation last month was a big achievement, the USFDA approval reinforces Orchid’s position on the safety of the drug and its innate need in the times of increasing Antimicrobial resistance.”
Enmetazobactam, invented by Orchid Pharma in India and out licensed to Allecra Therapeutics for further development, has garnered attention after the Dhanuka Group acquired Orchid Pharma through CIRP (Corporate Insolvency Resolution Process) under IBC (Insolvency and Bankruptcy Code) on March 31, 2020.
The company’s foray into the US market with the launch of Enmetazobactam marks a significant step for Orchid Pharma, reaffirming its position as a vertically integrated pharma player. With the USFDA approval, the company is poised to make further inroads into the global pharmaceutical market.
–IANS
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