Hospira expects Vizag plant to start commercial production in first half of 2015

Pegs capital expenditure for capacity expansion at the plant at approximately $450 million

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.

The plant is located in a special economic zone and started operations in 2011. The company has pegged capital expenditure for capacity expansion at the plant at approximately $450 million.

"We incurred total capital expenditure of $328.1 million through December 31, 2014. Capital expenditures were $100.9 million, $74.1 million and $73.4 million in 2014, 2013 and 2012, respectively," it added.

Besides Vizag plant and the plants it acquired from Orchid Chemicals and Pharmaceuticals, the company has purchased certain oncology drugs from Zydus Hospira Oncology Pvt Ltd, a joint venture with Gujarat-based Cadila Healthcare Ltd. 

US pharmaceutical major Pfizer recently announced acquisition of Hospira Inc for $17 billion consideration, which is expected to fetch it the manufacturing capacities in India including the Vizag plant.