Sandoz Withdraws from Salbutamol Production Amid EU Regulations

In a significant shift for asthma treatment, Sandoz has announced its intention to cease production of salbutamol-containing emergency inhalers, citing regulatory changes mandated by the European Union. The decision stems from the recent enforcement of the F-Gas Regulation, which aims to phase out fluorinated greenhouse gases in pharmaceutical manufacturing, specifically hydrofluorocarbons (HFCs).

This announcement follows an ongoing shortage of salbutamol inhalers that has been affecting the market since late 2023. The Federal Institute for Drugs and Medical Devices (BfArM) has indicated that this shortage is not directly linked to the new regulations but rather to a surge in global demand. Challenges in sourcing and maintaining quality standards for the materials used in inhaler production have further compounded these supply issues.

While BfArM has not confirmed any specific withdrawals from the market by existing license holders, Sandoz has reiterated its plans to phase out production at its facility in Rudolstadt. The company has indicated that the costs associated with upgrading its production processes to comply with the new environmental standards are prohibitively high and unsustainable.

The transition away from salbutamol production raises concerns about the availability of effective asthma treatments in the coming years. Sandoz is currently exploring alternative supply solutions to mitigate potential impacts on patient access to essential medications.

In response to the evolving landscape, BfArM has noted that there are two applications for new drug approvals currently under review. These approvals could pave the way for improved supply conditions in the future, although specific details about the applicants or the nature of the products remain undisclosed.

As the pharmaceutical industry grapples with these changes, stakeholders are closely monitoring the situation. The implications of the EU's regulatory framework are being debated, particularly regarding their potential to disrupt access to vital medications. Industry experts are calling for a balanced approach that addresses environmental concerns while ensuring that patients have access to necessary treatments.