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Macitentan manufacturers

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Country of origin : Portugal

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1 products found


Tablets, film coated 10 mg

Dossier type
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
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 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.