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China halts imports of Pfizer drug on paperwork glitch
China suspended imports of U.S. drugmaker Pfizer Inc’s AIDS-related drug Diflucan, citing a problem with late paperwork, the country’s food and drug watchdog said in a statement on its website.
Pfizer, the largest drugmaker in the United States, contravened Chinese law when one of its France-based factories failed to submit a supplementary application on time, the China Food and Drug Administration (FDA) said in the statement.
With the country’s healthcare spending forecast to nearly triple to $1 trillion by 2020 from $357 billion in 2011, according to consulting firm McKinsey, China is a magnet for makers of medicines and medical equipment.
Pfizer has taken steps to resolve the issue and is working with China’s FDA to ensure its products comply with Chinese law, it said in a statement on its Chinese-language website. The issue is not linked to quality or safety, it added.
Some analysts said the incident looked like a paperwork “glitch” and should be short-lived.
“It should not impact too much Pfizer’s business in China and I am sure the imports will be resumed once the procedure is complete,” said Simon Li, Shanghai-based general manager at Kantar Health China.
China has been cracking down this year on the healthcare sector, with investigations ranging from allegations of corporate bribery to how drugs are priced, as well as drives to increase quality and safety levels across the sector.
Diflucan, which treats fungal infections linked to AIDS, had worldwide sales of $259 million in 2012, according to Pfizer’s latest annual financial statement, a small fraction of the firm’s $59 billion revenue that year. Pfizer has more than 9,000 employees in China and operates in more than 250 Chinese cities. (Reuters)
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