Emmaus Life Sciences Announces Submission of Marketing Authorization Application for Endari® to the Saudi Food & Drug Authority
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TORRANCE, Calif., May 26, 2021 /PRNewswire/ Emmaus Life Sciences, Inc. (OTC: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, announced today that its application for Marketing Authorization (MA) for Endari® in the Kingdom of Saudi Arabia has been accepted by the Saudi Food and Drug Authority (SFDA). The SFDA s MA review and approval process typically takes 12 to 18 months. Endari®, Emmaus prescription grade L-glutamine oral powder, is approved by the United States Food and Drug Administration for treating sickle cell disease in adult and pediatric patients five years of age and older.
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Credit: Abdul Latif Jameel Health
A recently established health solutions provider has partnered with Saudi Arabia’s Ministry of Health to bring a “pioneering” heart surgery procedure to the Kingdom.
Abdul Latif Jameel Health – which was formed in 2020 with the mission to tackle “disparity in access to modern medical care” – has launched the AVNeo (Aortic Valve Neo-cuspitization), used in surgical reconstruction of the aortic heart valve. It is described as a cheaper yet safe alternative that creates movement close to that of a natural valve compared to other aortic valve replacement procedures.
The partnership marks the debut of the AVNeo in the Gulf Cooperation Council (GCC), making Saudi Arabia the first country from the region to offer this advanced solution.
Prime Certification and Inspection, a subsidiary of the United Arab Emirates – based Prime Group of Companies, has been recognized by the Saudi Food and Drug Authority (SFDA) and the only Philippine halal-certifying body authorized to give certification for food exports bound for the Kingdom of Saudi Arabia.
In a statement, Prime said this followed after new regulations were implemented by the Saudi government last November 2020 stipulating that meat, poultry, and their derivative products can only be exported to the country if they have halal certificates issued by a body accredited and approved by the SFDA, which regulates food, drug, and medical devices both imported and domestic for the conservative Islamic country.The new regulation comes as the global halal food industry continues to grow with a total deal value of $6.3 billion in 2020.