Published On:February 14 2015
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US-based generic injectables major, Hospira expects its greenfield manufacturing facility in Vizag, Andhra Pradesh, to start commercial production in the first half of 2015.
'The first commercial production is expected during the first half of 2015, with production expected to increase over the course of the next several years,' the company said in its Annual Report for the year 2014.
In March 2014, after a pre-approval inspection at the facility, the US Food and Drug Administration (FDA) had issued Form 483, listing 10 observations to the company.
Hospira responded to these observations, and in July 2014 received an untitled letter requesting additional information regarding two of its corrective actions. The company has responded to this letter and would continue working to resolve the FDA's concerns, it said.
'Our ability to commercially sell products produced in Vizag within the US ultimately depends on receiving FDA approval,' it said.
BS