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Macitentan manufacturers

19 products found

Filters

19 products found

macitentan

Tablets, film coated 10 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #21467

Manufacturer usually replies in 9 days

macitentan

Tablets, film coated 10 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Portugal , Vietnam
Manufacturer #437
A pharmaceutical manufacturer based in the EU that is active in 40+ countries selling its products in Europe, North America, LATAM, Africa, Middle East, and Asia for 40+ years. Main therapeutics areas include the nervous system, cardiometabolic, and women’s health. The company's production lines are GMP-compliant. The main dosage forms are solid, semi-solid, liquid, and suspension. The company owns branches in the EU, Africa, and LATAM.

Manufacturer usually replies in 11 days

macitentan

Tablets 10 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Available for
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.

Manufacturer usually replies in 12 days

macitentan

Tablets, film coated 10 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Iceland
GMP approvals
EU GMP
Manufacturer #28915

Manufacturer usually replies in 14 days

macitentan

Tablets, film coated 10 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
EU GMP
Unavailable markets
Bulgaria , Costa Rica , Albania , Bosnia And Herzegovina , Kosovo , Serbia , Slovenia
Manufacturer #361

It is a global player with more than half a century of experience. It has more than 4 facilities to operate from. They have marketing and promotion in more than 20 countries. It exports to more than 50 countries. The only motto is to improve the quality of human life and to provide access to reliable, high-quality products for human health worldwide. It is focused to create its own cadres in every country it operates.

Manufacturer usually replies in 9 days

macitentan

Tablets 10 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Turkey
GMP approvals
EU GMP
Manufacturer #13095

Manufacturer usually replies in 5 days

macitentan

Tablets 10mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Turkey
GMP approvals
EU GMP
Unavailable markets
Albania , Iraq
Manufacturer #281
It is a leading European pharmaceutical firm that strives to create a powerful global brand with innovative goods and services, as well as bold and pioneering activities, by working passionately to heal the lives they touch. The business was founded in the 1900s. In the interest of public health and the national economy, the firm launched the project to promote public awareness about the unintentional use of medications.

Manufacturer usually replies in 8 days

macitentan

Tablets, film coated 10 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Unavailable markets
Chile , Panama
Available for
Licensing with supply
Manufacturer #261
A pharmaceutical manufacturer based in the EU that has been selling its products in Europe for 20+ years. Main therapeutic areas include diabetes, CNL, dermatology, and oncology. Main dosage forms include solid and liquid oral, sterile dosage forms, and ointments. The company possesses 10+ manufacturing facilities that are cGMP-compliant.

Manufacturer usually replies in 6 days

macitentan

Tablets 10mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #13291

Manufacturer usually replies in 6 days

macitentan

Tablets 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
GMP, United Kingdom
Unavailable markets
United Kingdom
Manufacturer #33476

macitentan

Tablets, film coated 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
EU GMP, PICS
Manufacturer #2760

Manufacturer usually replies in 5 days

macitentan

Tablets, immediate release (IR) 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #17331

Manufacturer usually replies in 8 days

macitentan

Tablets, film coated 10 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
Turkey
Comments
Reference Product : Opsumit
Manufacturer #2748
It is a privately held pharmaceutical company based in southeast Europe that was established in the 1990s to import and introduce pharmaceutical items into medicine. The company began by importing hemophilia and intensive care supplies, as well as immunoglobulin-containing items. To suit market demands, the company has added additional dermatological, cardiological, urological, and surgical goods to its portfolio since then. They now offer a diverse product line that includes not only prescription but also OTC, medical gadgets, and dermo-cosmetics.

Manufacturer usually replies in 7 days

macitentan

Tablets, immediate release (IR) 10 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA, EU GMP, WHO, INVIMA
Manufacturer #16394

Manufacturer usually replies in 12 days

macitentan

Tablets 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
South Korea
GMP approvals
EU GMP, WHO, PICS
Manufacturer #20943
It is a leading innovation-driven pharmaceutical/healthcare company. It develops, manufactures, and distributes healthcare solutions to improve the health and quality of human life. It was founded in the 1950s and has been dedicated to developing and providing innovative pharmaceutical products (prescription drugs & OTC drugs), medical devices, and in-vitro diagnostics.

Manufacturer usually replies in 13 days

macitentan

Tablets, film coated 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
PICS
Comments
Co-development projects, the manufacturer has commercial rights for TR and US markets
Manufacturer #13510
It was established in the 2010s. It creates and sells biotech products developed with natural product extracts, helping to improve your heart health, immune system, or mood. It offers the pharmaceutical and nutraceutical industry a natural, science-based therapeutic alternative that can be safely used either in combination with existing medications as add-on ingredients for improved efficacy or presented as a single standing remedy; with patented products, proven benefits, and claims for our natural ingredients in the areas of for example mood improvement, anxiety and stress reduction, eye-health, cardiovascular health advancement and enhancement of the body´s immune system against cold and flu.

Manufacturer usually replies in 6 days

macitentan

Tablets, immediate release (IR) 10 mg

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA, Canada
Manufacturer #16394

Manufacturer usually replies in 12 days

macitentan

Tablets, film coated 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Argentina
GMP approvals
PICS, AR
Manufacturer #15733
One of the leading manufacturers in cosmetic and medicinal products in the South American Continent. The company has been committed since 1990-is to developing and manufacturing high-quality products that allow healing and improve someone’s life. They are a major exporter of its therapies to different regions such as Latin America and Asia. Medicine is manufactured for pain, gastroenterology, hepatology, and cardiology.

Manufacturer usually replies in 17 days

tadalafil + macitentan

Tablets, film coated 40 mg + 10 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Turkey
GMP approvals
PICS
Manufacturer #13510
It was established in the 2010s. It creates and sells biotech products developed with natural product extracts, helping to improve your heart health, immune system, or mood. It offers the pharmaceutical and nutraceutical industry a natural, science-based therapeutic alternative that can be safely used either in combination with existing medications as add-on ingredients for improved efficacy or presented as a single standing remedy; with patented products, proven benefits, and claims for our natural ingredients in the areas of for example mood improvement, anxiety and stress reduction, eye-health, cardiovascular health advancement and enhancement of the body´s immune system against cold and flu.

Manufacturer usually replies in 6 days

Macitentan is popular with its trade name Opsumit. It is an Endothelin Receptor Antagonist [ERA] and has been permitted by the medical council for the treatment of pulmonary arterial hypertension. The other two popular ERAs are Ambrisentan and Bosentan. Macitentan serves as dual ERA which implies that it acts as an antagonist of subtypes of two ET receptors. The US Food and Drug Administration approved the use of Macitentan on the 13th of October, 2013. Macitentan manufacturers have since then strived to cope up with the demand for this drug. A black box warning has also been issued by the FDA for embryo-fetal toxicity. The drug is recommended for female patients only after carrying out thorough risk evaluation and mitigation strategy program. Macitentan lowers blood pressure in the lungs thereby assisting the heart to pump blood in a more efficient manner. The drug is primarily used for treating pulmonary arterial hypertension. It also enhances your ability to exercise, thereby preventing worsening of the medical condition. Macitentan suppliers have monetized this application of the drug quite well. Endothelin is a potent blood vessel constricting agent secreted by endothelial cells present in our body. ET-1 is the most common form of ET released in the lungs. What Macitentan does is block the independent rise of ET-1 in intracellular calcium by resulting in inhibition of binding of ET-1 to ET receptors. Blocking of the ETA receptor has a crucial role to play in the treatment of pulmonary arterial hypertension. It also blocks simulators of vasoconstriction, proliferation, fibrosis, inflammation and hypertrophy. It Macitentan is usually taken as an oral dosage of 10 mg once a day. It has a half-life of 16 hours in humans. It also reaches a steady-state by the third day of drug administration. It absorbs into the plasma at a slow pace. One should refrain from using Macitentan if they are allergic to anaemia, heart disease and liver disease. Macitentan manufacturers offer this drug in the form of crystalline powder. It is insoluble in water. It is quite stable in the solid stable and is not light sensitive or hygroscopic. In drug stores, Opsumit is available for sale in the form of a 10 mg tablet. It is film-coated and should be orally taken once a day. The tablet also includes inactive ingredients such as sodium starch, magnesium stearate, microcrystalline cellulose and lactose monohydrate. The effectiveness of Macitentan was established based on several studies carried out in PAH patients and based on results on clinical studies. Hence, you cannot place an order for this pharmaceutical product online. You will not find it for sale easily. Macitentan suppliers provide the drug only to registered distributors. Macitentan is a medication with limited distribution. This implies that you cannot purchase it from local pharmacy stores. Women can take this drug only after undertaking a pregnancy test or after clearing the REMS program. This is because there is a high risk of damage to a fetus or embryo if a woman becomes pregnant while on this drug. Men can take it freely without becoming a part of the REMS program. However, the distributors do exercise caution while selling the wholesale product and make sure that the drug does not go into the wrong hands. In several nations, those that are not enrolled in the REMS program would not be able to avail of the benefit of receiving drug-free of charge for the first month. It is essential to receive insurance approval before starting this therapy as well in specific nations. 15 tablets in the US cost around £2306.00. The manufacturers are trying ways to cut down the wholesale costs by tweaking their manufacturing practices. Still, a significant improvement is needed in this regard from the manufacturers. Recently, the company Actelion Pharmaceuticals received USDA approval for selling Opsumit for treatment of arterial hypertension. Actelion, a Janssen Pharmaceuticals company immensely popular for offering quality pharmaceutical products in the marketplace at an affordable price. This announcement has created quite a buzz in the global marketplace. If you are eager to monetize the opportunity, then PipelinePharma will help you connect with the right partners. The platform lists reputed manufacturers and suppliers so that you can connect to them with much ease. Assistance is offered to negotiate commercial terms and any other assistance required.