Orchid Pharma bags FDA approval for Enmetazobactam, first Indian-invented beta lactamase inhibitor

Chennai-based Orchid Pharma has achieved a significant milestone by receiving approval from the United States Food and Drug Administration (USFDA) for Enmetazobactam, marking a pivotal moment in the pharmaceutical industry. This approval comes shortly after the European Medicines Agency (EMA) recommended the drug for approval, highlighting the global recognition of this innovative treatment. Enmetazobactam stands out as the first Beta Lactamase Inhibitor completely developed in India, showcasing the country’s growing capabilities in pharmaceutical research and development.

The USFDA’s green light for Enmetazobactam signifies a major leap forward for Orchid Pharma, enabling the company to introduce this critical drug into the United States, the world’s largest pharmaceutical market. The product launch is anticipated within the next few quarters, offering a new solution for patients suffering from complicated urinary tract infections (cUTI), including pyelonephritis. The approval of Exblifep (Cefepime and Enmetazobactam) as an injection highlights its effectiveness against various microorganisms such as Escherichia coli and Klebsiella pneumoniae, among others.

Orchid Pharma’s achievement is not just a win for the company but a landmark event for India’s pharmaceutical sector, marking the first time an Indian company has received a New Drug Approval (NDA) from the USFDA. This development is particularly significant in the fight against Anti-Microbial Resistance (AMR), offering an affordable and efficacious option in the global drug market.

On this remarkable occasion, Manish Dhanuka, Managing Director of Orchid Pharma, expressed his pride in the USFDA approval and the EMA’s recommendation, underscoring the drug’s safety and its critical role in addressing the challenge of increasing antimicrobial resistance. “First discovered in 2008, it has taken 16 years of painstaking work to bring this product to market,” he noted, highlighting the extensive research and testing that underpinned the drug’s development.

Orchid’s collaboration with Allecra Therapeutics for the further development of Enmetazobactam underlines the global partnership and innovation driving this project. This USFDA approval not only celebrates Indian innovation but also reinforces India’s position as a leading player in the global pharmaceutical industry, capable of developing groundbreaking drugs.