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Drug firm Zydus Cadila today said Zydus Hospira Oncology, a JV between the company and Hospira Inc, has received Establishment Inspection Report (EIR) from the US health regulator for its Ahemdabad manufacturing facility.
The EIR from the United states Food and Drug Administration (USFDA) has concluded that the inspection is closed but has also said that the inspection classification of this facility is ‘voluntary action indicated’ (VAI).
According to the USFDA, VAI means that though objectionable conditions were found and documented, but the agency is not prepared to take or recommend regulatory action.
Zydus Hopsira Oncology is a 50:50 joint venture company between Zydus Cadila and Hospira Inc USA (now part of Pfizer Group), Zydus Cadila said.
The manufacturing plant had completed the USFDA audit from April 5 to April 12, 2018, it added.
Shares of Cadila Healthcare, the listed entity of the group, were ended at Rs 366.30 per scrip in the afternoon trade on BSE, down 1.40 per cent from its previous close.
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