It is poetic that following the close of the Olympics in Beijing – an event that went very well in spite of all the worries leading up to it – that Boehringer Ingelheim announces a cooperation deal with a Chinese company calleed Hisoar. If you google the company, there is an indication that it goes to an English langugage page, but it doesn’t.
According to the press release, this is a "strategic production alliance." The aim of the agreement would appear to allow the Chinese company to manufacture chemical intermediates for eventual use in eventual drug products.
There is nothing surprising about this, and in fact, it is done already and makes perfect sense in today’s globalized economy. But I think for companies doing this, in the wake of the heparin issue, there is both a challenge and an opportunity for companies as they embark on these kinds of agreements.
Challenges first. If components of compounds are being made in foreign countries, then some in the U.S. might ask what could be the problem in individuals purchasing their drugs from outside of the U.S. at lower prices. Second, in the wake of the heparin issue, the FDA went to great lengths to announce that it was opening offices in China and sending personnel there.
That leads to the opportunity. There is no question that the volume of work to be done through foreign inspections will quickly outstrip any capacity on the part of FDA to inspect foreign manufacturing facilities, meaning that private industry using foreign companies for the supply of raw materials will need to step up to ensure quality and safety under these circumstances. Again, from the press release:
From September 2008 onwards, Boehringer Ingelheim will supply know-how as well as technical support for production to Hisoar. Hisoar in turn will invest into new specific production facilities for Boehringer Ingelheim at its new site in Chuannan. The production for Boehringer Ingelheim in Chuannan is planned to start in early 2009.
Mr. Bangpeng Luo, the Chairman of Hisoar commented: We are very pleased to have the opportunity to cooperate with Boehringer Ingelheim, a large multinational pharmaceutical company. This cooperation, both from the technical and the management level, will raise Hisoar’s market positioning and standing and it will create an unusual benefit for Hisoar to enter the international level of raw material suppliers, and indicates that Hisoar has come a big step forward towards internationalization.”
The announcement of the cooperation agreement is a good step at demonstrating the company’s role, though it might have gone further in specifically addressing quality control and standards. And it might not be a bad idea to provide updates that specifically allude to quality control that can bolster the case for what has become in today’s economy, a standard practice of manufacturing.
