Euticals Limited has halted API production at its Welsh site after local authorities found it was housing “substantial” quantities of a potentially explosive chemical.
The chemical in question – Isosorbide Dinitrate (ISDN Pure) – is a by-product of ISMN Isosorbide Mononitrate which is the active pharmaceutical ingredient used in angina treatment, and the site's main.
The materials were discovered during an Environment Agency Wales inspection following a chemical spill which resulted in three workers being taken to hospital.
Speaking to in-PharmaTechnologist.com, the firm’s on-site director Timothy Dowd said: “ISMN is a back- bone product of the site," adding, “the amount of material held is not significantly different to levels held in previous years.”
When asked how long the break in production is expected to last, Dowd replied: “This is unknown. We are working with the authorities to treat the material and remove from site. The method of treatment and disposal has to be agreed with the UK authorities and executed before we can contemplate restarting production.”
in-PharmaTechnologist.com also spoke to Flintshire Country Council chief executive, Colin Everett, and asked why the high levels of highly-flammable materials had not been discovered before, and whether regulations will be upped in response to the incident.
He replied: “The HSE and Environment Agency Wales are the responsible authorities under the Control of Major Accident Regulations 1999, and it is for them to determine the frequency of site inspections to comply with the regulations.
“The UK has a comprehensive set of regulations covering industrial site operations and these are updated in line with European Legislation.”
In a statement, Euticals said ISMN is recognised as a crucial part of the manufacturing supply chain for a “very important medication.”
Dowd was unable to comment on which manufacturers will be affected by the stopped production, or how many countries the temporary gap in the supply chain could affect. He explained: “This is commercially sensitive infomation and unfortunately we cannot comment on this question.”
As for working with the regulators to resolve the issues, he added: “We have worked over the last week with the UK regulators and authorities in the direct resolution of this issue. Pharmaceutical regulators will now be informed as necessary.”