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Country of origin : Spain

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4 products found

fingolimod

Capsules 0.5 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Albania , Andorra , Austria , Belarus , Belgium , Bosnia And Herzegovina , Bulgaria , Croatia , Cyprus , Czech Republic , France , Germany , Greece , Hungary , Italy , Kosovo , Liechtenstein , Luxembourg , North Macedonia , Malta , Montenegro , Moldova , Monaco , Netherlands , Poland , Portugal , Romania , Russia , Serbia , San Marino , Slovakia , Slovenia , Spain , Switzerland , Ukraine
Available for
Licensing with supply, Distribution only
Comments
PATENT EXPIRY: Q2 2027
Manufacturer #573
A pharmaceutical manufacturer based in the EU that has been active in 50+ countries selling its products in Europe, North America, LATAM, Africa, and Asia for 30+ years. Key production lines are Rx and nutraceuticals. Main therapeutic areas include CNS and respiratory. Main dosage forms include sterile forms and oral solid. The company's production lines are EU GMP-compliant. The company owns 10+ branches in Europe.

Manufacturer usually replies in 7 days

fingolimod

Capsules 0.25 mg, 0.5 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
Ref. Gilenya
Manufacturer #31058

This company, based in Europe, is a pharmaceutical manufacturer with a history spanning over seven decades. They focus on the development, production, and marketing of generic and value-added medicines, catering to patients globally. Their expertise lies in complex generics and their portfolio includes prescription drugs and over-the-counter medications. They hold significant experience in the industry, with strong manufacturing capabilities in Europe and North America, backed by GMP certifications. The company has a robust track record of growth, demonstrated by its international presence and expansion into key regions such as Europe and North America. Key therapy areas include cardiovascular, oncology, and gastrointestinal disorders. Their production lines include solid dosage forms, injectables, and liquids.

Manufacturer usually replies in 8 days

fingolimod

Capsules 0.25 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
Ref: Gylenia®
Manufacturer #252
This company is a leading player in the pharmaceutical industry, boasting decades of experience in research, development, and manufacturing. They specialize in the production of a wide range of pharmaceutical ingredients (APIs) and finished dosage forms (FDFs) for both human and veterinary use. Their product portfolio spans multiple therapeutic areas, including but not limited to, oncology, cardiology, and other essential therapeutic categories. They offer a comprehensive range of services, including contract manufacturing (CMO) and the production of over-the-counter (OTC) products. The company holds EU and US GMP approvals for its production lines, ensuring adherence to rigorous quality standards. Their production lines encompass various dosage forms, including solids, liquids, and injectables. Their global presence extends across Europe and North America, with a network of 10 manufacturing facilities. They have a strong commitment to research and development, with dedicated teams focusing on innovative solutions and advancements in the pharmaceutical field.

Manufacturer usually replies in 12 days

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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.

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