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Laurus Labs unit gets Slovenian body OK to export hydroxychloroquine

Thursday, Jul 9, 2020

 

By Chiranjivi Chakraborty

 

MUMBAI – The Slovenian drug regulator has approved Laurus Labs Ltd’s facility in Vishakhapatnam, Andhra Pradesh, for export of controversial anti-malarial drug hydroxychloroquine sulphate following a virtual inspection on May 4, a copy of the certificate accessed by Cogencis showed.

 

Laurus Labs is one of the largest producers of the anti-malarial drug in India, which has been touted by some as a potential treatment for COVID-19.

 

The drug’s use for treatment of COVID-19 patients was recently revoked by the US Food and Drug Administration as it has concerns over its effectiveness and potential side-effects.

 

The Slovenian regulator said that the inspection was limited to primary and secondary packaging of hydroxychloroquine sulphate 200 mg into bottles on the bottle packaging line 1 and line 2.

 

Slovenia’s Agency for medicinal products and medical devices has certified that Laurus Labs’ facility conforms with the regulator and European Medicine Agency’s good manufacturing practices guidelines, a copy of the certificate accessed by Cogencis showed.

 

The certificate is valid for the next three years and allows the company to export the drug packaged at the unit to the Slovenian market and other countries members of the European Medicine Agency.

 

The Slovenian drug regulator said that it will conduct an on-site inspection of the facility as and when circumstances permit.

 

The approval from the drug regulator comes a few weeks after the Indian government lifted the ban on export of hydroxychloroquine drug. Laurus Labs, however, was exempt from the ban as its facility was located in a special economic zone, meant mainly for exports.

 

At 0955 IST, shares of Laurus Labs were up 2% at 565 rupees on the National Stock Exchange.  End

 

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Edited by Arshad Hussain

 

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This copy was first published on the Cogencis WorkStation

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