Centrient Pharma announces 100 per cent compliance for clean manufacturing of its oral antibiotic products

Centrient Pharma announces 100 per cent compliance with the stringent Predicted No Effect Concentration (PNEC) discharge targets set by the AMR Industry Alliance for clean manufacturing of its full oral antibiotics product range. The standard covers both Centrient’s sites and its suppliers’ sites. This achievement positions the company as a frontrunner in the industry with the delivery of responsibly-produced antibiotics, which minimise the possible contribution to antimicrobial resistance, a company statement said.

The statement notified that the PNEC discharge target is the concentration of an antibiotic in water at which there is unlikely to be a risk of adverse environmental effects or of antimicrobial resistance (AMR) developing. These scientific, risk-based targets were developed by the AMR Industry Alliance and cover around 120 Active Pharmaceutical Ingredients (APIs) used in antibiotic manufacturing. Each individual antibiotic has a corresponding PNEC value, published in the AMR Industry Alliance table of Recommended PNECs for Risk Assessments (updated periodically).

High concentrations of antibiotic residues in factory wastewater can create hotspots of resistant bacteria which may lead to AMR. While manufacturing is just one of the contributors to the emergence of AMR in the environment, its impact cannot be overlooked. AMR is a major threat to global public health as well as to the healthcare industry. Many standard medical procedures such as organ transplants, chemotherapy, and surgeries such as caesarean sections become much more dangerous without effective antibiotics to prevent and treat infections. Antibiotics are the cornerstone of our modern healthcare system, and complying with PNEC standards enables manufacturers to ensure supply of these critically important medicines does not contribute to the risk of AMR, the statement added.

It further mentioned that the PNEC values are increasingly being recognised as the standard for antibiotic discharge concentrations in water and are expanding beyond alliance companies and their supply chains. For example, tenders in the UK and Germany (health insurer AOK) include a specific reference to the PNEC discharge targets. In addition, companies assessed externally by organisations such as the Access to Medicine Foundation will have public exposure for their performance on PNECs.