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| Exchange Received Time 09/03/2018 14:57:11 Exchange Disseminated Time 09/03/2018 14:57:17 Time Taken 00:00:06 | Panacea Biotec Ltd. is pleased to announce the receipt of Establishment Inspection Report (EIR) from the U.S. Food & Drug Administration ('USFDA') indicating the formal closure of the Inspection conducted by USFDA, at its Pharmaceutical Formulation Facility for Oncology Parenteral and Oral Solids Dosage at Malpur, Baddi, District Solan, Himachal Pradesh, India.
The release of EIR notification by USFDA indicating inspection is 'closed' means, the USFDA has concluded review of the Company's manufacturing activities and the company is allowed to continue supply of all the approved drug products by USFDA into inter-state commerce. The EIR notification also accelerates approval process for submitted drug product applications.
A copy of the Press Release being issued to the media, etc. in this regard is enclosed for your kind reference and record please. |
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