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Sharon Bio Medicine receives EIR from USFDA for Taloja plant

20 Sep 2016 Evaluate

Sharon Bio Medicine has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (USFDA) conducted during period ranging from June 29, 2015 to July 7, 2015 at Active Pharmaceutical Ingredient (API) plant located at L-6, MIDC, Taloja, Dist. Raigad, Maharshtra. The API Plant now is approved by USFDA. The payment for Generic Drug User Fee (GDUFA Fees) is pending and therefore supply to the United States of America cannot be done unless pending arrears are cleared.

Sharon Bio-Medicine is into manufacturing and supply of Active Pharmaceutical Ingredients (APIs).

Peers
Company Name CMP
Sun Pharma Inds. 1675.20
Dr. Reddys Lab 1235.40
Cipla 1238.30
Zydus Lifesciences 942.55
Lupin 2324.25
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