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Fingolimod manufacturers

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Country of origin : Greece

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Capsules 0.5 mg

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Dossier status
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Country of origin
European Union
GMP approvals
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Licensing with supply, Technology transfer
Manufacturer #260
Pharmaceutical manufacturer operating in the EU for 50+ years. Activities include scientific development, manufacturing, out-licensing, marketing, and distribution of high-quality generic medicines. The company owns several production facilities that all comply with EU GMP requirements. Key dosage forms include conventional solids, cytostatic injectables, and cytostatic orals. The company holds an in-house R&D and Intellectual property business unit, as well as a regulatory affairs team that prepares CTD dossiers and maintains direct contact with regulatory agencies worldwide. The portfolio includes more than three thousand MA sets approved in the EU while hundreds of MA are in progress. Key therapy lines are cardiovascular, CNS, diabetes, immunology, oncology, and more. The company is active in nearly 100 countries worldwide, selling its products in Africa, Asia, Australia, Europe, LATAM, and the Middle East.

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Fingolimod is popularly referred to by its trade name Gilenya. The drug is primarily used for the treatment of multiple sclerosis and is an immunomodulating drug. In various research studies, it has been established that this medication can lower the relapse rate by half over a two-year period. The drug functions by sequestering lymphocytes in the lymph nodes, inhibiting them from resulting in an autoimmune reaction. The manufacturers are facing a huge demand for the drug. This is because of its ability to inhibit the triggers experienced by Multiple Sclerosis patients.
Although Fingolimod is not a medication for treating multiple sclerosis, it can help in preventing the immune system cells from attacking the nerves of the spinal cord and the brain. It lowers the episodes that can worsen the condition. This drug can also be used for the treatment of chronic inflammatory demyelinating polyneuropathy. The cost of 30 oral capsules of Gilenya of 0.5 mg strength is $9,053 in the US whereas in the UK it costs about £1,470. The price is further reduced if the patient is enrolled in any medical scheme.
Fingolimod was synthesized for the first time in the year 1992 by Yoshitomi Pharmaceuticals. It was a derivative of a natural product Myriocin. A special chemical modulation process was used for its synthesis. The company first isolated Myriocin from a culture of Isaria Sinclairii which is a kind of fungus. This fungus is believed to be a source of eternal youth nostrums as per traditional Chinese medicine. The drug demonstrated positive results during both in-vitro and in-vivo studies. The manufacturers found great potential in the drug during the studies.
During September 2010, Fingolimod became the first oral disease-modifying drug to be approved by the US Food and Drug Administration (FDA). It lowers relapses and also delays disability progression in patients. Novartis is the chief Fingolimod manufacturer in the world. The company started selling this drug in Canadian pharmacies from April 2011. The drug was approved by the European Medicines Agency in March 2011 for use in the European Union. Since then, several Fingolimod suppliers have made their way into the market. The wholesale market has witnessed a splurge after approval from major governing bodies. The distributors are cashing in the situation. There was a clash in 2015 at the US Patent and Trademark Office over the drug by a generic competitor. Novartis’s claim for the patent was squashed by the patent office. The leading Fingolimod manufacturer then appealed to the federal circuit which upheld the decision in 2017. Generic Fingolimod was approved in the USA in 2019 for treating the condition of Multiple Sclerosis. Sun Pharma, Biocon Limited, and HEC Pharm Co. Limited were granted approval by the FDA. Gilenya by Novartis secured the approval for the drug in China in July 2019. The manufacturers are trying their best to secure deals in various countries. Fingolimod suppliers are leaving any opportunity to make the best out of the situation currently in the global market.
The FDA has issued a safety warning to the users that when the usage of Fingolimod is discontinued, the condition can actually worsen that it was before starting the intake of the drug. Hence, care needs to be exercised by the medical practitioners before starting the treatment with this drug. The distributors are required to exercise care over the wholesale dealings of this drug to ensure that the regulations are being followed.
Pipelinepharma is a leading platform to connect with the leading Fingolimod manufacturers in the world. If you are a distributor, then you can enter into deals or negotiations with manufacturing companies after completing the free registration process on our website.