Farmak International Secures First Marketing Authorization in China for MRI Contrast Agent
Farmak International is proud to announce a significant milestone: the successful registration of our MRI contrast agent in the People's Republic of China.
December, 2024
Farmak International is proud to announce a significant milestone: the successful registration of our MRI contrast agent, Gadoteric Acid, under registered name “Gadoteric Acid Meglumine Salt Injection”, in the People’s Republic of China. This achievement follows rigorous audits and compliance with China’s stringent regulatory standards, underscoring our commitment to delivering high-quality pharmaceutical products globally.
About Gadoteric Acid Meglumine Salt Injection:
Gadoteric Acid Meglumine Salt Injection is a gadolinium-based contrast agent (GBCA) extensively used in MRI diagnostics to deliver precise, high-quality imaging1,2. Key highlights of Gadoteric Acid Meglumine Salt Injection include:
– Proven Reliability: Gadoteric acid, the active ingredient, is one of the most studied GBCAs with an established safety profile and over 30 years of clinical application3.
– European Standards: Produced in compliance with EU Good Manufacturing Practices (Directive 2003/94/EC) and ISO 9001:2015, ensuring consistent quality and reliability.
– Market Leadership in Europe4: Trusted by healthcare providers across Europe for its favorable safety profile1,2, effectiveness1, and quality. Gadoteric acid is a well-established gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI) to enhance the clarity of diagnostic images. It has been utilized in clinical practice for several decades3, demonstrating a favorable safety profile1,2,*.
Strategic Expansion into the Chinese Market
Securing marketing authorization in China represents a strategic expansion for Farmak International into one of the world’s largest and most dynamic healthcare markets. China’s complex regulatory environment requires a thorough and detailed approach, making the successful registration of Gadoteric Acid Meglumine Salt Injection a significant milestone for the Company. This launch underscores our capability to deliver innovative, high-quality solutions to healthcare systems in diverse markets.
Commitment to Quality
Gadoteric Acid Meglumine Salt Injection, along with our other contrast media products, adheres to international quality standards. Our manufacturing processes comply with the European Commission Directive 2003/94/EC on Good Manufacturing Practices (GMP) and meet the requirements of ISO 9001:2015, ensuring the highest level of product safety and efficacy.
Opportunities for Collaboration
As we introduce Gadoteric Acid Meglumine Salt Injection to the Chinese market, we are eager to explore partnerships with distributors and healthcare providers to enhance diagnostic capabilities across the region. In addition to Gadoteric Acid Meglumine Salt Injection, Farmak International offers a comprehensive portfolio of contrast media designed to meet diverse clinical needs.
For detailed information on our product offerings, please visit our product catalog: Farmak International Product Catalog.
About Farmak International:
Farmak International is a pharmaceutical company committed to delivering innovative healthcare solutions to improve lives worldwide. With a growing presence in international markets, we are driven by our mission to drive high-quality medicines worldwide.
For partnership inquiries or more information, please contact:
- Ota, J. Kimura,T. Ishiguchi. Safety and clinical usefulness of gadoteric acid including post-marketing surveillance. Imaging Med. (2012) 4(4), 397- 409
- Michael A. Ibrahim; Bita Hazhirkarzar; Arthur B. Dublin. Gadolinium Magnetic Resonance Imaging. 2023. https://www.ncbi.nlm.nih.gov/books/NBK482487/
- https://www.guerbet.com/en-us/products-solutions/contrast-agents/dotarem-gadoterate-meglumine-injection. Accessed 27 Dec 2024. Gadoteric Acid (Dotarem, Guerbet) was launched globally in 1989 and approved by the FDA for use in the US in 2013.
- IQVIA Q4 2022
SmPC short version.
Gadoteric Acid. Active substance: gadoteric acid; 1 mL of solution contains gadoteric acid 279.32 mg (0.5 mmol), which corresponds to gadoterate meglumine 376.92 mg; Excipients: meglumine, water for injections. Pharmaceutical form. Solution for injection. Pharmacotherapeutic group. Paramagnetic contrast agents. Gadoteric acid. ATX code V08C A02. Indications. Contrast enhancement in MRI of the brain and spinal cord of adults and children (0-18 years): detection of tumors of the brain, spine, surrounding tissues, prolapse of intervertebral discs, infectious diseases. MRI of the whole body, including imaging of pathology of the kidneys, heart, uterus, ovaries, thoracic and abdominal organs, bone and joint pathology. Angiography. Contraindications. Hypersensitivity to gadoteric acid, meglumine or to any medicinal product containing gadolinium. Use during pregnancy and lactation. Gadoteric acid should not be used during pregnancy unless the woman’s clinical condition requires it. Children. Due to immature renal function in neonates up to 4 weeks of age and children under 1 year of age, gadoteric acid should be used in these patients only after careful consideration of all risks. Undesirable effects. Side effects associated with the use of gadoteric acid are usually mild or moderate in severity and short-lived. Injection site reactions, nausea and headache are the most common. Special warnings and precautions for use. Do not use intrathecal administration. Strictly follow the rules of intravenous injection: extravasation can lead to local intolerance reactions that require routine local treatment. Routine precautions should be taken when performing MRI scans: patients may have pacemakers, ferromagnetic clamps, infusion pumps, nerve stimulators, cochlear implants, or suspected intracorporeal metallic foreign bodies, especially in the eye. WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF). Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: – Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or – Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended Gadoteric Acid dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration. Storage. Does not require special storage conditions. Keep out of reach of children. Package. 5 mL, 10 mL, 15 mL, 20 mL, 60 mL, 100 mL of solution in vials. 1 vial in a pack. Pre-filled syringes 10 mL, 15 mL, 20 mL. Prescription only. Producer. JSC “Farmak”
*WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
- The risk for NSF appears highest among patients with:
– Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
– Acute kidney injury.
- Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
- For patients at highest risk for NSF, do not exceed the recommended Gadoteric Acid dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.