Organon has opened an upgraded facility in China, currently used for the production of intrauterine devices (IUDs) for contraception, that will for the first time allow it to start producing pharmaceutical dosage forms.
The upgrade brings it into line with China's updated requirements for Good Manufacturing Practice (GMP) compliance.
The facility, operated by local joint venture Nanjing Organon Pharmaceutical, already manufactures the company's Multiload IUD, but the upgrade means that Organon can now manufacture pharmaceutical products there for the Chinese market. One of the key new products to be made at the plant will be Livial (tibolone), the Dutch firm's oral treatment for menopausal symptoms and osteoporosis in post-menopausal women.
Organon made the decision to invest in the plant upgrade in December 2002, a year after China implemented its drug law to bring its domestic industry into line with World Trade Organisation rules. This included an updating of the country's existing regulations on GMP, originally developed in the 1980s, to WTO standards.
At the time the new law was introduced, it was estimated that China had around 7,500 enterprises making pharmaceuticals in 1998, but only 87 had any form of GMP certification. With the implementation of the new law, 6300 domestic pharmaceutical enterprises will be required to abide by WTO-standard GMP before the end of 2004.
Nanjing Organon's factory is the only operational site the Dutch company operates in China. In addition to switching to the manufacture of pharmaceuticals for the domestic marketplace, it will still make IUDs, with a production capacity of six million Multiloads a year.