Mumbai-based pharmaceutical company Cipla has received approval from the Central Drugs Standard Control Organization (CDSCO) to market plazomicin, an antibiotic, in India for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis (kidney infection).
Plazomicin is a new intravenous (IV) aminoglycoside that has demonstrated efficacy and safety in clinical trials compared to meropenem (antibacterial agent). It also retains activity against strains resistant to older aminoglycosides.
Cipla USA, a subsidiary of Cipla, holds the patent for plazomicin sulfate and markets the product under the brand name ZEMDRI in the USA, where it received approval from the US FDA in 2018.
"The introduction of plazomicin in India is an important step forward in bringing solutions that address the evolving healthcare challenges of our time," said Umang Vohra, Managing Director, and Global CEO, Cipla. "Cipla remains steadfast in building capabilities and driving stewardship activities to counter the global threat of antimicrobial resistance (AMR). Our focus remains on developing a robust antimicrobial portfolio, forging partnerships with thought leaders and industry alliances to ensure global access to antimicrobial drugs for a healthier life."
Cipla is also implementing programs to address AMR, including Environmental, Health, and Safety (EHS) management programs, strengthening wastewater and solid waste management, and providing training towards its sustainability initiatives.
Established in 1935, Cipla is a global pharmaceutical company with a focus on complex generics, and deepening its portfolio in key markets. With 47 manufacturing sites globally, producing 50+ dosage forms and 1,500+ products, Cipla ranks as the 3rd largest pharma company in India and the 3rd largest in the pharma private market in South Africa.