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Swedish Regulators close  down Imports from AstraZeneca’s Indian API Plant

European imports from AstraZeneca’s now-closed terbutaline sulphate active pharmaceutical ingredient (API) manufacturing facility in Bangalore, India were halted by Swedish Regulators for API. European imports from AstraZeneca’s now closed terbutaline sulphate (API) manufacturing facility in India were halted by Sweden’s Medical Products Agency after failed validation runs. “The concerned API-batches or finished product containing the API should not be imported to the European Economic Area,” the regulatory agency said. “All API batches manufactured during the year 2014 are concerned. This includes all batch numbers starting with TAIO and TABO.” “It is recommended that the site is not approved in any new or ongoing applications before a re-inspection has confirmed GMP-compliance,” they added.

“The company received the non-compliance statement.”All batches of API terbutaline sulphate (TBS) manufactured at the site and released for formulation in 2014 met registered specifications," said Abigail Bozarth, spokeswoman from AstraZeneca.

Of the 24 deficiencies found during the inspection in January, none of the deficiencies was critical but four were major” the agency revealed. Eight API batches were released from the site in India without any restriction, but they were retested and released a second time in Sweden. Sweden’s Medical Products Agency said that even though it told the company in June to recall all terbutaline sulphate batches not supported by an acceptable validation, the batches “have not been recalled but the further use of them has been stopped.” The Swedish regulator requested the Indian officials to recall the written GMP confirmation for the site.


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