Saudi Food and Drug Authority

King Faisal Specialist Hospital and Research Centre Seeks to Achieve Self-Sufficiency in Radiopharmaceuticals in the Kingdom

Retrieved on: 
Monday, October 30, 2023
RC, Education, Radiopharmaceutical, Good manufacturing practice, Cyclotron, ISO 9001, Research, KFSH, King Faisal Specialist Hospital and Research Centre, Hospital, Saudi Food and Drug Authority, GMP, Nuclear medicine, PET/CT, Patient, ISO, SFDA, Medical imaging, Kingdom

Since its establishment, the department has produced over 25 types of radiopharmaceuticals with a production capacity exceeding 600,000 radiopharmaceutical preparations.

Key Points: 
  • Since its establishment, the department has produced over 25 types of radiopharmaceuticals with a production capacity exceeding 600,000 radiopharmaceutical preparations.
  • The department continues to provide its products to over 50 specialized Saudi medical centers, aiming to achieve self-sufficiency in the field of radiopharmaceuticals in the Kingdom of Saudi Arabia.
  • The Cyclotron and Radiopharmaceuticals Department aspires to become a diagnostic and molecular imaging center and the first facility for Technetium-99m (Tc-99m) generators in the Kingdom.
  • It conducts research to develop high-quality radiopharmaceuticals for KFSH&RC and other hospitals throughout the Kingdom to meet all healthcare needs of patients.

Celularity Announces Commercial Biomaterial Products Receive Saudi Food and Drug Authority (SFDA) Product Classification

Retrieved on: 
Wednesday, October 18, 2023
Islam, Halal certification in Australia, Certification, Umbilical cord, Placenta, Trauma, PTD, Partnership, Saudi Food and Drug Authority, CELU, Classification, Kingdom, SFDA, Medical device, Sharia, Instituto de Biologia Molecular e Celular

FLORHAM PARK, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies and advanced biomaterial products, today announced that its Halal Certified biomaterial products have been classified by the Saudi Food and Drug Authority (SFDA) as “Minimally Manipulated Biological Products” for importation license purposes in the Kingdom of Saudi Arabia. The SFDA independently reviewed and issued classifications for each of the following Celularity Halal Certified biomaterial products:

Key Points: 
  • FLORHAM PARK, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies and advanced biomaterial products, today announced that its Halal Certified biomaterial products have been classified by the Saudi Food and Drug Authority (SFDA) as “Minimally Manipulated Biological Products” for importation license purposes in the Kingdom of Saudi Arabia.
  • The SFDA independently reviewed and issued classifications for each of the following Celularity Halal Certified biomaterial products:
    Biovance®, a decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy.
  • Biovance® is an intact, extracellular matrix structure that provides a natural scaffold to support the body’s wound-healing process.
  • “The SFDA’s Minimally Manipulated Biological Product classification establishes a clear regulatory pathway for the importation of our Halal Certified biomaterial products into Saudi Arabia,” said Robert J. Hariri, M.D., Ph.D., Chairman, CEO, and Founder of Celularity.

Nemaura Medical Completes 100 Patient Study for sugarBEAT® 24-hour Wear and Reports Interim Results

Retrieved on: 
Monday, September 11, 2023
CGM, CE, Male, Type 2 diabetes, Diabetes, Nemaura Medical, Saudi Food and Drug Authority, SFDA, Person, MARD, Patient, Ageing, NMRD, Skin, Female, Calibration

The Company has previously received CE approval in Europe, and SFDA (Saudi Food and Drug Authority) approval for its sugarBEAT® glucose sensor for a wear period of 14 hours.

Key Points: 
  • The Company has previously received CE approval in Europe, and SFDA (Saudi Food and Drug Authority) approval for its sugarBEAT® glucose sensor for a wear period of 14 hours.
  • This study was designed to evaluate several factors, including the possibility of increasing the wear period to up to 24 hours, evaluating the possibility of auto-calibration, and different methods of application of the device to the skin.
  • The Company reports interim data from a first cohort comprising 25 patients, on a single day sensor wear.
  • The results indicate that a 24-hour sensor wear period using a single sensor is possible, which is expected to allow users to monitor their glucose fluctuations overnight.

Nemaura Medical Announces SFDA Approval of sugarBEAT®

Retrieved on: 
Thursday, August 17, 2023
Obesity, Type 2 diabetes, Prevalence, Diabetes, Nemaura Medical, Economist, Saudi Food and Drug Authority, SFDA, Government, Economist Intelligence Unit, Risk, NMRD, News, Pharmaceutical industry

Loughborough, England, Aug. 17, 2023 (GLOBE NEWSWIRE) -- Nemaura Medical, Inc. (Nasdaq: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing and commercializing a daily disposable, wearable glucose sensor and supporting personalized lifestyle coaching programs, today announced SFDA (Saudi Food and Drug Authority) approval of sugarBEAT®, its non-invasive wearable glucose sensor.

Key Points: 
  • Loughborough, England, Aug. 17, 2023 (GLOBE NEWSWIRE) -- Nemaura Medical, Inc. (Nasdaq: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing and commercializing a daily disposable, wearable glucose sensor and supporting personalized lifestyle coaching programs, today announced SFDA (Saudi Food and Drug Authority) approval of sugarBEAT®, its non-invasive wearable glucose sensor.
  • The report states that nearly 4.5 million people, or 18.3% of the adult population in Saudi Arabia, have diabetes, compared to a global average of 9.3%.
  • Nemaura Medical is in advanced discussions to play a pivotal role in the region with its superior sensor technology, and diabetes and metabolic health management programs.
  • The Company believes that SFDA approval places Nemaura Medical in an unparalleled position to gain approval across the Gulf and other regions, and to commercialise its digital programs.

Saudi Arabia FMCG (Fast-Moving Consumer Goods) Full Market Entry Report 2023: Building Success and Winning Strategies for Entering the Booming Market - ResearchAndMarkets.com

Retrieved on: 
Monday, August 7, 2023
Retail, Other Retail, Final good, Knowledge, Growth, KSA, Saudi Food and Drug Authority, FMCG, Social media, Marketing, SFDA, Safety, Video game, Sales

Entering the FMCG (Fast-Moving Consumer Goods) industry in Saudi Arabia (KSA) presents both opportunities and challenges.

Key Points: 
  • Entering the FMCG (Fast-Moving Consumer Goods) industry in Saudi Arabia (KSA) presents both opportunities and challenges.
  • However, it is essential to understand the market dynamics and navigate the regulatory landscape to successfully enter the KSA FMCG industry.
  • One of the critical aspects of entering the KSA FMCG industry is understanding the local market and consumer preferences.
  • Understanding the consumer market, building strategic partnerships, complying with local regulations, and implementing effective marketing strategies are key to successfully establishing a presence in the competitive KSA FMCG industry.

Saudi Arabia FMCG (Fast-Moving Consumer Goods) Activations & Market Entry Rates Guide 2023 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 21, 2023
Other Consumer, Consumer, Final good, Saudi Food and Drug Authority, FMCG, Social media, Research, Safety, Marketing, SFDA, Internet, Fast-moving consumer goods, Sales, Retail, KSA

When entering the FMCG (Fast-Moving Consumer Goods) industry in Saudi Arabia (KSA), understanding FMCG activations and market entry rates is essential for a successful market entry strategy.

Key Points: 
  • When entering the FMCG (Fast-Moving Consumer Goods) industry in Saudi Arabia (KSA), understanding FMCG activations and market entry rates is essential for a successful market entry strategy.
  • Here is a guide to FMCG activations and market entry rates in KSA.
  • In conclusion, FMCG activations and market entry rates are critical considerations when entering the KSA market.
  • By implementing effective activations and considering market entry rates, FMCG companies can position themselves for success in KSA.

Amarin Announces Vascepa® (Icosapent Ethyl) Approved to Reduce Cardiovascular Risk in the Kingdom of Saudi Arabia (KSA)

Retrieved on: 
Wednesday, June 21, 2023
China Biologic Products, Intellectual property, Research and development, Diabetes, Dyslipidemia, CV, Marketing, Saudi Food and Drug Authority, Cardiovascular disease, SHC, KSA, SFDA, TG, Amarin, Professional corporation, IPE, Development, Capsule, Publication, Patient, Risk, NHC, Kingdom, United Arab Emirates, Pharmaceutical industry

DUBLIN, Ireland and BRIDGEWATER, N.J., June 21, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) and its commercialization partner Biologix FZco, a company based in the United Arab Emirates and a pioneer in the distribution of pharmaceutical and biological products in the Middle East and North Africa, today announced that the Kingdom of Saudi Arabia’s (KSA) Saudi Food and Drug Authority (SFDA) has approved a new indication and label expansion for VASCEPA® (icosapent ethyl) capsules. VASCEPA is now the first and only drug approved by SFDA as an adjunct to statin therapy in adult patients with elevated triglycerides (TG) levels (≥150 mg/dL) who are at high-risk of cardiovascular (CV) events due to established cardiovascular disease or diabetes mellitus and at least one other risk factor for cardiovascular disease.

Key Points: 
  • VASCEPA is now the first and only drug approved by SFDA as an adjunct to statin therapy in adult patients with elevated triglycerides (TG) levels (≥150 mg/dL) who are at high-risk of cardiovascular (CV) events due to established cardiovascular disease or diabetes mellitus and at least one other risk factor for cardiovascular disease.
  • “We are excited that patients in KSA will now have the opportunity to benefit from the proven cardiovascular risk reduction with VASCEPA following the approval by the SFDA,” said Steven Ketchum, PhD., President, Research & Development and Chief Scientific Officer, Amarin.
  • “Today’s approval also marks an important step in our strategy to expand the global footprint where VASCEPA/VAZKEPA is indicated for cardiovascular risk reduction, built from the results seen in the REDUCE-IT outcomes trial.
  • Amarin is responsible for providing regulatory assistance, supply and maintaining intellectual property in the region.

Saudi Arabia Antibiotics Markets, Competition, Forecast & Opportunities, 2027 - Cephalosporin, Penicillin, Amoxicillin, Azithromycin, Clindamycin, Tetracycline - ResearchAndMarkets.com

Retrieved on: 
Friday, January 27, 2023
Infectious Diseases, Pharmaceutical, Health, Capsule, Administration, Penicillin, Urinary tract infection, Infection, Government, Virus, Viral, Investment, Cephalosporin, COVID-19, Disorder, Saudi Food and Drug Authority, Drug development, Market, Route of administration, Certification, Research, Ministry, Death, SFDA, Antibody, Disease, Sanofi, Growth, Spectrum, Bacteria, Clindamycin, Tablet, Grindeks, Pharmaceutical industry, Vaccine, Arms industry, Azithromycin, Amoxicillin, Sepsis, Tetracycline

Saudi Arabia antibiotics market is anticipated to register growth with an impressive CAGR in the forecast period, 2023-2027, on the account of increasing instances of infectious diseases.

Key Points: 
  • Saudi Arabia antibiotics market is anticipated to register growth with an impressive CAGR in the forecast period, 2023-2027, on the account of increasing instances of infectious diseases.
  • Saudi Arabia pharmaceutical industry grossed USD8.35 billion in the year 2019 that further registered growth of USD10.19 billion in 2020.
  • promotes the requirement for the antibiotics and thus supports the growth of the Saudi Arabia antibiotics market in the next five years.
  • Company Profiles: Detailed analysis of the major companies present in Saudi Arabia antibiotics market.