Ceftolozane Sulfate Market

Ceftolozane sulfate, a broad-spectrum semi-synthetic cephalosporin antibiotic, is used mostly in combination with tazobactam sodium as brand name Zerbaxa™. This combination is active against multidrug-resistant Gram-negative bacteria, including Pseudomonas aeruginosa, and is indicated for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), and hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).

The ceftolozane sulfate manufacturing process has also made immense progress in being more efficient and sustainable. There were originally three steps involved using hazardous chemicals in the first steps, yielding lower outputs with extended cycle times. Merck constructed a second-generation (Gen 2) route of manufacturing involving the implementation of a crystallization-based purification technology instead of classical chromatography practices. This break-through increased yield, lowered solvents, improved cycle times, and decreased its impact on the environment.

The drug industry has been quite interested in ceftolozane sulfate, as reflected by several requests for its supply. Drug companies from different nations, such as India, China, Egypt, Pakistan, and Bangladesh, have requested ceftolozane sulfate for development and commercialization, reflecting a strong demand for this antibiotic.

Regulatory clearance has been key to the industrial profile of ceftolozane sulfate. The United States Food and Drug Administration (FDA) licensed the ceftolozane/tazobactam combination for therapeutic use, acknowledging its efficacy in curing serious infections. Approval involved thorough scrutiny of the production process, product characteristics, and clinical effectiveness to align with safety and quality criteria..