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Health Regulatory Authority In The US Inspects Sharon Bio-Medicine’s Dehradun Plant

by Lakshmi Darshini on  August 19, 2015 at 7:26 PM Drug News   - G J E 4
Pharmaceutical company, Sharon Bio-Medicine's formulation plant in Dehradun was inspected by the US Food and Drug Administration on August 18.
Health Regulatory Authority In The US Inspects Sharon Bio-Medicine’s Dehradun Plant
Health Regulatory Authority In The US Inspects Sharon Bio-Medicine’s Dehradun Plant
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"In the last week one of our formulation plants at Dehradun in Uttarakhand has been inspected and audited by US Food and Drug Administration (USFDA) officials," Sharon Bio-Medicine said in a Bombay Stock Exchange filing. The company's manufacturing facility at Taloja near Navi Mumbai had been inspected by the USFDA, it added.

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"This is our second plant which has been inspected and audited by USFDA officials in the last two months. First plant at Taloja near Navi Mumbai was inspected and audited in the first week of July 2015," the company said.

A warning letter to the firm was issued by the USFDA for failing to pay generic drug user fee by its owner for 3 months starting 2013, saying its Dehradun-based facility would be barred from shipping products to the US if the dues are not cleared.

Source: Medindia
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