Hovione to Sell iMAX Business, Reports Site Inspections

Portuguese CDMO to Withdraw from Generic Contrast Media Manufacturing, Facilities in Portugal, Macau, Ireland in Full Compliance

08.03.2018 -

Hovione plans to withdraw from generic contrast media manufacturing to focus on other business segments including contract development and manufacturing of innovative therapies and manufacturing of off-patent APIs. In a statement released on Mar. 7, 2018, the Portuguese CDMO reported that it concluded the sale of all of the share capital of iMAX Diagnostic Imaging Holding Limited, ending 24 years of supplying iopamidol and iohexol active pharmaceutical ingredients (APIs) to the generic industry globally. The company initiated expansion plans for its API and drug product business in 2016 and said it will focus on drugs that are difficult to make and formulate.

Hovione entered the generic contrast media business in 1993 and in 2007 moved most of its manufacturing to the iMAX factory in China. The business showed a steady profit growth and for most of that period represented the largest tonnage of Hovione’s product portfolio, the company reported.

“Our contrast media business is growing and has many loyal clients that demand high quality, but it increasingly does not seem a good fit with the rest of our activities. The opportunity to sell iMAX with its manufacturing business of APIs and formulated product to a market leader makes sure this business can continue to develop even better,” stated Guy Villax, Hovione’s CEO.

The Portuguese CDMO also announced that in the last year their manufacturing facilities in Portugal, Macau and Ireland were the object of eight inspections, performed by different health authorities. The inspections revealed that all Hovione sites were in compliance, this reflects a solid quality system and a vibrant quality culture. This is the first press release that in the previous year.  Such reports on the outcomes of inspections will now become a regular feature of Hovione’s commitment to transparency.

“Each inspection at Hovione is considered to be of highest importance for the organization and for our customers. We are considering every audit and every inspection as a learning opportunity to continuously improve our Quality Systems and Operative Mechanisms. The number of inspections and their outcome demonstrate our commitment and capacity in the development of new drugs, and ability to manufacture highest quality products for our customers as well as for millions of patients that we proudly serve together. We are especially happy to share that all of the GMP surveillance inspections were concluded successfully with no form 483 observation. ” said Joerg Gampfer, Vice President of Quality at Hovione.

“We have a culture of quality that puts patient safety first. These inspections are important steps for Hovione and our customers. They shape our behaviors and motivate us to always improve our services to customers. Hovione has all the ingredients for an outstanding partnership going from clinical programs all the way to commercial supply.” added Frédéric Kahn, Vice President Marketing and Sales.



Sete Casas
2674-506 Loures