Hovione shows off Irish API plant

By Gareth Macdonald

- Last updated on GMT

Related tags Pharmacology Active ingredient Pharmaceutical drug

API maker Hovione’s manufacturing facility in Cork, Ireland was unveiled at an opening ceremony yesterday just two weeks after the previous owner, global drug giant Pfizer, formally handed over the keys.

The plant can handle a large number of specialised operations such as hydrogenation and low temperature chemistry, and boasts a new, €70m ($91m) spray-dried formulations unit.

Under Pfizer the facility's main focus was the production of the active ingredient for the firm's biggest seller, the world leading hypertension blockbuster Lipitor (atorvastatin).

Before Hovione bought the plant last year Pfizer had been trying to sell it for 12 months as part of a wide-ranging to cut manufacturing capacity and prepare for the loss of patents on key products, including Lipitor.

Hovione said it will continue to make some active pharmaceutical ingredients (API) on Pfizer’s behalf, but stressed the production of its roster of drug actives as well as contract manufacture will be the main focus of activities at the site.

In a press statement, Lorcan MacGarry, Hovione’s general manager in Ireland said: "We will be transferring to the Cork site a number of compounds over the next 18 month​s,” including approved APIs made at its plant in the Loures, Portugal.

Cork and China

Over the last few years Hovione has increased API manufacturing capacity by around 50 per cent in response to the rising demand for outsourced manufacture that currently dominates the drug industry.

While the firm has established manufacturing operations in Portugal and China, the latter through its majority ownership of Hisyn Pharmaceutical, the Cork plant is the first it owns in Ireland's API producing hub.

A Hovione spokesperson told in-PharmaTechnologist that the high proportion of available capacity, excellent engineering standards and the "large number of 6 sigma green and black belt [trained] individuals,​" were key factors in the decision to buy the facility.

"We expect to have 80 team members running the plant for the first 18 months, this is the time it will take for the plant to be qualified and registration validation batches to be produced and put on stability. After this time we will have actual routine manufacturing campaigns; when we have a good percentage of the site filled headcount will increase.​"

She went on to say that: "Adding the Cork site to the Hovione group provided our customers with the best of both worlds: access to the kind of facilities that only Large Pharma can afford, with all the benefits associated with Hovione flexibility and speed, service and compliance.

Another factor in the decision to set up in Ireland were growing industry-wide concerns about some APIs and drugs sourced in Asia, which was a problem alluded to by Hovione CEO Guy Villax in December when the plant acquisition was announced.

He said that: “We have been manufacturing in China for over 25 years - we know very well what China can do for the Pharma industry, but we also know what it can't do - and it is for those reasons that we are now in Cork​.”

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