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Gulf Pharmaceutical Industries (Julphar), Abu Dhabi-listed pharmaceutical manufacturer, is expecting re-inspection of its facilities by the Saudi Food and Drug Authority (SFDA) to take place shortly, according to company CEO Jerome Carle.
“We have been in close contact with the SFDA since September 2018 to address the recommendations highlighted in their report. We strive to be a successful company in the region and we understand that this is only possible if we work in partnership with authorities such as the SFDA,” he told Argaam in an emailed statement.
However, no specific timeframe for inspection was given. In March, Carle told Argaam that he expects everything to be resolved in the "next few weeks".
In December last year, the Ras Al Khaimah-based drug maker was granted a new current Good Manufacturing Practice (cGMP) certification from the UAE’s Ministry of Health and Prevention. In April 2019, it was successfully audited by Saudi-based Gulf Health Council (GHC).
“This is a clear indication that our products meet all the necessary regulations and standards,” Carle stated.
“Our stringent policies and procedures ensure we are in full compliance with regulatory requirements and we routinely welcome inspections from the world’s leading regulatory authorities,” he added.
In an earlier statement, Julphar said its 2018 revenue had been negatively impacted by product recalls and the SFDA’s temporary ban on exports to the Kingdom.
However, the drug maker said it is “well-placed to navigate the risks inherent in today’s world and the long-term drivers of revenue growth remain sound.”
Write to Parag Deulgaonkar at parag.d@argaamplus.com
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