Hospira gets nod from US FDA to manufacture products at AP plant

The company may receive US product approvals from the facility in future

Hospira Inc, the generic injectables firm acquired by Pfizer recently, has received the US Food and Drug Administration (FDA)’s nod to manufacture finished dosage drugs at its Visakhapatnam facility in Andhra Pradesh.

It may be noted that the US regulator has issued a Form 483, notifying the company management of objectionable conditions they have observed during the plant inspection.

Hospira today said that Hospira Healthcare India Private Limited, a subsidiary of Hospira, Inc, received official notification from the US FDA that the inspection of the Visakhapatnam, was deemed acceptable for the manufacture of finished dosage drugs, on June 23, 2015.

"As a result of this action, the company may receive US product approvals from this facility in the future," said the company in a regulatory filing in US.

The FDA has conducted a pre-approval inspection of the Vizag facility from February 16 to February 25, 2015, following which a Form 483 containing 14 observations was issued. According to the FDA website, an FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The company responded to the Form 483 on March 18, 2015, and submitted additional support documentation by the end of May.

"The inspection was found to be acceptable following the FDA's review of the Company's responses and support documentation. The Company has begun limited commercial production at the facility," said the company.
 

 

The plant, which is expected to manufacture speciality injectables, is being set up at a cost of $375-450 million, said the company had said earlier.

On February 5, 2015, Pfizer Inc and Hospira Inc announced they had entered into a definitive merger agreement under which, Pfizer would acquire Hospira, the world’s leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, for $90 a share in cash for a total enterprise value of approximately $17 billion.

In December 2009, Hospira acquired the generic injectables business of Orchid Pharma, including the beta-lactam antibiotics manufacturing complex and research and development facility in Irungattukottai, near Chennai, along with its generic injectables product portfolio and pipeline, for about $400 million. In 2012, it had announced the acquisition of Orchid Pharma's penicillin and penem active pharmaceutical ingredient (API) business and the API facility at Aurangabad, Maharashtra, along with associated research & development infrastructure in Chennai, through its Indian subsidiary, for about $200 million.