scrambles for ingredients to make generic Nexium
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[March 11, 2014]
By Sumeet Chatterjee and Ben
MUMBAI / LONDON (Reuters)
— Indian drugmaker Ranbaxy
Laboratories Ltd is in talks with at least two companies on sourcing
ingredients for a generic version of AstraZeneca Plc's heartburn
drug Nexium, a source said, to ensure the pills can be sold in the
The United States banned shipments from one of
Ranbaxy's plants in India following an inspection that found poor
manufacturing practices, effectively barring India's top drugmaker
by revenue from selling drugs in the United States from its India
Ranbaxy's Ohm Laboratories plant in New Jersey is now the only
facility that makes generics for the United States.
Any delay in launch of generic Nexium, AstraZeneca's second-biggest
seller, will have a big impact on the British company's profit.
Nexium had global sales last year of $3.87 billion and U.S. sales of
Retaining exclusivity on Nexium in the all-important United States
beyond the end of May would not only limit a forecast decline in
AstraZeneca's 2014 earnings but could also protect bonuses for top
management at the British company.
Ranbaxy's talks with ingredient makers are part of a scramble to
ensure it can still be the first to sell a cheaper copy of Nexium in
the United States after the drug's patent term ends on May 27,
despite regulatory sanctions for production quality.
The source, who has direct knowledge of the matter, declined to give
details and refused to be named due to the sensitivity of the issue.
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A Ranbaxy spokesman said the company has no comment for now.
Doubts about the ability of India's top drugmaker by revenue to
launch the drug grew after the FDA in January prohibited it from
shipping to the United States any pharmaceutical ingredient made at
its Toansa plant in northern India.
(Additional reporting by Zeba Siddiqui
in Mumbai; editing by Anna Willard)
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