This site is intended for Healthcare professionals only.

Zydus Hospira Oncology gets EIR for its Ahmedabad facility


Zydus Hospira Oncology gets EIR for its Ahmedabad facility

New Delhi: Drug firm Zydus Cadila 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 Hospira 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.



Source: PTI
0 comment(s) on Zydus Hospira Oncology gets EIR for its Ahmedabad facility

Share your Opinion Disclaimer

Sort by: Newest | Oldest | Most Voted