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COURTING JAPAN
CPhI JAPAN: Foreign suppliers
of pharmaceutical chemicals affirm
commitment to country’s market
LIKE PATIENT SUITORS, suppliers of active
pharmaceutical ingredients (APIs) and intermediates
are undeterred in courting Japanese drug
companies. Last week in Tokyo, exhibitors at the fine
chemicals trade show CPhI Japan suggested that those
pharma companies’ resistance to dealing with foreign
suppliers is diminishing.
Japanese pharma traditionally has been conservative
in sourcing ingredients. Although not unknown, reliance
on parties beyond a small circle of suppliers was rare.
Changes in Japan’s regulations, however, raised outsiders’
hopes of breaking through the circle (C&EN, May 15,
2006, page 29). That hasn’t happened as quickly as outsiders
had anticipated, but they are not discouraged.
Takuya Yamamoto, of trading company Koa Shoji,
said drug companies are still looking at the same suppliers,
but he expects the pool to increase eventually. Similarly,
Jagmohan M. Khanna, of Indian contract manufacturer
Jubilant Organosys, predicted that “the Japanese
market is going to open up gradually because of costs.”
According to Yamamoto, Europeans have an edge
among foreign suppliers. “They already know about
quality and are easy to trust,” he said. They are also famil-
JUNGLE SKY
AIR CHEMISTRY: Forest air can do more
oxidizing than previously thought
LONG-HELD BELIEFS about the chemical makeup
of the atmosphere above pristine rain forests
are being called into question by new research
that could inform air pollution modeling and regulation
in areas that are more urban.
All forms of foliage emit vast amounts of hydrocarbons
into the sky, far more than cars do. In fact, trees
and plants expel about 500 billion kg of isoprene per
year—which is approximately the combined weight of
every human in the world. But the atmospheric lifetime
of these hydrocarbons is just a few hours, much shorter
than that of anthropogenic hydrocarbons, says Jonathan
Williams, an atmospheric scientist at Max Planck
Institute for Chemistry in Mainz, Germany.
Near urban centers, isoprene reacts with polluting
nitrogen oxides to form smog. Researchers have long
thought that above pristine jungles and forests, isoprene
is oxidized by hydroxyl radicals, thereby depleting
the overall oxidative potential of jungle skies.
NEWS OF THE WEEK
iar with drug master
files, the data that
Japanese law now
requires companies
to submit for APIs.
European firms
themselves tout
these qualities: regulatory
experience,
reliability, and a
deep understanding
of quality’s primacy.
As Wilhelm Stahl,
head of Saltigo’s pharma business, put it, “If you have
quality issues, you have a big mess.” Still, Stahl admitted
that breaking through in Japan will take time. “With
Japan, one has to take a long-term view,” he said.
Because of difficulties that can arise from cultural
differences, Japanese will always prefer to work with
Japanese, contended Ichiro Shinkai, of Beta-Chem, a
chemical development arm of Mitsui & Co. Foreigners
would do well to adapt Japanese business ways, he said.
Almac, a Northern Irish pharma services firm, heeds
the advice. Companies can fail in Japan for boorishness,
according to David Moody, vice president of
commercial operations. Almac has made inroads in the
country partly through the respectful demeanor of the
people it sends there, he claimed. The cultural sensitivity
has reaped projects that are small but have growth
potential, added Rosaleen McGuckin, vice president of
business development.—MAUREEN ROUHI
But when Williams, Jos Lelieveld, and their colleagues
from Max Planck Institute for Chemistry sent a
Lear jet packed full of equipment over South American
jungles, they found that OH radicals are not depleted
at all but exist at the same concentrations as over the
oceans. The authors suggest that hydroxyl radicals are,
in fact, being recycled, not used up, by jungle-emitted
isoprene (Nature 2008, 452, 737).
“Jungles rely on an oxidative atmosphere to create
the concentration gradients required for chemical
ecology to work”—so a pollinating insect can hone in
on nectar in a flower, for example, Williams says. “It’s
amazing that the jungle can maintain levels of HO∂”
required for a healthy ecosystem.
The new findings also call into question models that
air pollution regulators have been using to estimate
the levels of smog and ozone in forested areas downwind
of urban nitric oxide emissions, comments Alex
Guenther, a senior scientist with the National Center
for Atmospheric Research, in Boulder, Colo. “Hydroxyl
radicals are critical compounds in the air, but they are
also really hard to measure,” Guenther says. “When the
concentration of HO∂ changes, the concentration of
everything in numerical models changes.” Regulators
should, therefore, pay close attention to these findings,
he notes.—SARAH EVERTS
WWW.CEN-ONLINE.ORG 13 APRIL 14, 2008
CPhI Japan attracted
about 15,000 visitors,
organizers say.
ALEX GUENTHER/© 2008 NATURE
The air above South
American forests is
more oxidative than
previously thought.
MAUREEN ROUHI/C&EN