Pfizer’s Tamil Nadu injectibles plant gets 11 USFDA observations

Photo courtesy: ReutersThe US drug regulator has issued 11 observations on Pfizer’s manufacturing facility in Sriperumbudur, Tamil Nadu, which came in as a part of Pfizer’s Hospira acquisition. The plant makes injectable productsThe observations by the US Food and Drug Administration (FDA) include responsibilities and procedures related to quality control unit not being completely followed, lack of complete data related to laboratory records, issues related to the written records of investigations related to failures, among others. The inspections were conducted in Hospira Healthcare India Pvt Ltd’s Sriperumbudur facility between March 27, 2018 and April 3, 2018.Pfizer company spokesperson said, “Inspections are a routine part of pharmaceutical manufacturing, and regulators inspect a number of our sites regularly. We do not comment on individual inspections.”The manufacturing facility, which became part of Pfizer following its acquisition of US-based Hospira in February 2015 in a $17 billion deal, had earlier also received observation from the USFDA as part of inspections in 2013 and 2015, according to reports.The facility was built by Chennai-based Orchid Pharma, which has been into manufacturing active ingredients and formulations, especially cephalosporin APIs and injectables manufacturer, from whom Hospira bought various businesses through two deals. Hospira bought the generic injectables business from Orchid Pharma in 2009 for a consideration of $400 million (Rs 18.50 billion as per the then currency rate).At the end of August 2012, Orchid announced the sale of its carbapenem and penicillin API manufacturing facility in Aurangabad, Maharashtra, along with the related R&D facility in Chennai and the product pipeline to Hospira for a consideration of $200 million (around Rs 11.50 billion during the period).
Source: Business Standard