Saturday, June 22, 2024

Bacterial Infections Breakthrough: Orchid Pharma Gains DCGI Approval for Enmetazobactam

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Orchid Pharma has recently received approval from the Drugs Controller General of India (DCGI) to manufacture and market Enmetazobactam for severe bacterial infections, a new chemical entity (NCE) and active pharmaceutical ingredient (API). The DCGI has also sanctioned the production and marketing of the finished dosage form (FDF) of Enmetazobactam in combination with Cefepime as a dry powder injectable. This approval marks a significant development in the treatment of severe bacterial infections, setting a new standard in the healthcare industry and potentially changing the clinical management of resistant bacterial infections.

TThe new antibiotic combination is designated for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. Additionally, it is indicated for more severe conditions such as hospital-acquired pneumonia (HAP), ventilator-associated pneumonia, and bacteremia that are associated with or suspected to be linked to either cUTI or HAP. This broad spectrum of applications highlights the critical role the new drug is expected to play in managing serious bacterial infections, thereby providing new hope for patients who suffer from these debilitating conditions.

Bacterial Infections and AMR: Orchid Pharma’s Strategic Response to a Global Health Crisis

Addressing the Global Challenge of AMR Antimicrobial resistance (AMR) is an escalating global health crisis, which the United Nations and the World Health Organization have declared a “silent pandemic.” Orchid Pharma’s combination drug emerges as a vital response to the urgent need for effective treatments against infections caused by resistant bacteria. The development is particularly crucial, considering AMR’s substantial threat to global health, contributing to an estimated five million deaths in 2019 alone, and signaling a call to action for healthcare providers worldwide.

Strategic Impact and Market Potential Orchid Pharma anticipates a successful launch and distribution of Enmetazobactam and its combination with Cefepime. The company aims to enhance the arsenal of treatment options available for serious bacterial infections in India, thereby addressing both a significant market and medical need. As the only Indian pharmaceutical company to have developed an NCE, Orchid Pharma underscores its commitment to pioneering significant healthcare advancements, poised to make a substantial impact on public health and patient outcomes.

Bacterial Infections

Leading Innovation in Bacterial Infections with Global Approvals and Quality Manufacturing

Global Approvals and Quality Manufacturing The molecule, which is out-licensed on a royalty basis, has already garnered approval in the US and Europe, affirming its international viability and efficacy. Orchid Pharma maintains one of the three US Food and Drug Administration (FDA)-approved facilities globally for the production of high-quality cephalosporins, particularly sterile products. This facility is the only one approved in India, highlighting the company’s capability in adhering to stringent global manufacturing standards and setting a benchmark for pharmaceutical manufacturing in the region.

Leadership and Commitment to Innovation Manish Dhanuka, the managing director of Orchid Pharma, expressed personal fulfillment with the DCGI’s approval, emphasizing the company’s intent to expand access to advanced and affordable treatment options in India. “Orchid Pharma is committed to innovation and is poised to provide an effective solution for patients suffering from severe bacterial infections, particularly in the face of rising antimicrobial resistance,” stated Dhanuka. This commitment is part of the company’s broader strategy to continue its dedicated efforts toward research and development to meet unmet medical needs, affirming its role as a leader in pharmaceutical innovation.

 

Resource: Pharmaceutical Technology, June 06, 2024

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