Leveraging on the company’s expertise in the development and manufacturing of soft gel capsules, IBSA has successfully developed an innovative formulation for L-thyroxin.

Please find here below the relevant details.

Description
Amber-colored, round/biconvex capsules of 7.3x5 mm that contain a viscous amber-colored liquid, packed in Pentapharm Aclar/aluminium blisters. 25, 50, 75, 100, 125 and 150 mcg are the USA approved strengths, each of them detected by dedicated colour on the blister and on the outer box.

Indication
Replacement or supplementary therapy of congenital or acquired hypothyroidism of any etiology, treatment or prevention of euthyroid goiters, adjunct to surgery and radioiodine therapy in thyrotropin-dependent thyroid cancer.

Status
Approved and launched in Switzerland, approved in USA, MRP for EU countries planned.

Claims
Patient friendly, innovative presentation claiming for better definition of the administered dose due to partition in liquid phase that ensures uniform distribution of the API and that does not need excessive heating and overaging of the formulation.

Countries available for licensing
All countries, except USA and Switzerland

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