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USFDA issues warning letter to Sharon Bio-medicine

Press Trust of India  |  New Delhi 

The US health regulator has issued a warning letter to Sharon Bio-medicine for failing to pay generic drug user fee by its owner for three years starting 2013, saying its Dehradun-based facility would be barred from shipping products to the US if the dues are not cleared.

In a warning letter, US Food and Drug Administration (USFDA) said the owner of Sharon Bio-medicine has failed to pay the appropriate facility fee for the facility as required by the Generic Drug User Fee Amendments of 2012 (GDUFA).

The facility has not paid the 2013, 2014 and 2015 facility fees as required by GDUFA, it said without specifying the amount.

"Any drugs or active pharmaceutical ingredients (API) manufactured, prepared, propagated, compounded, or processed at a facility for which required facility fees have not been paid or required self-identifying information has not been submitted, or drugs containing an active pharmaceutical ingredient manufactured, prepared, propagated, compounded, or processed at such a facility are misbranded," USFDA said.

It is a violation of federal law to ship misbranded products in interstate commerce, including causing such products to be imported into the United States, it added.

"Failure to correct these violations promptly may result in regulatory action, including but not limited to seizure or injunction without further notice. Your facility may also be placed on import alert such that any drug the facility manufactures will be refused admission into the United States," the US health regulator said.

The company should take prompt action to correct the violations noted above by immediately paying fiscal years 2013, 2014, and 2015 fees, it noted.

Sharon Bio-Medicine's Dehradun plant has annual capacity to produce 450 crore tablets and 75 crore capsules.

GDUFA was first passed into law in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA)-a legislation which contained hundreds of reform measures and several user fee components meant to increase funding for FDA.

Under GDUFA generic pharma companies are supposed to pay a fee to FDA for many of its routine activities, including generic drug filings and manufacturing facility inspections.

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First Published: Wed, July 08 2015. 20:07 IST