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desloratadine Tablets, film coated 5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Egypt
GMP approvals
Egypt
Manufacturer #21954

This CTD dossier owner and manufacturer, established in the Middle East, has been operating for over two decades. Their focus is on manufacturing and distributing branded generics, with a particular emphasis on providing quality medicines to the local region. They boast a significant workforce and an extensive product portfolio, including over 200 products. The company's key therapy areas include cardiovascular, gynecological, and gastrointestinal health. Their production lines include a wide range of dosage forms, such as solids, liquids, and injectables. They have obtained EU and US GMP approvals, demonstrating their commitment to high-quality manufacturing standards. Their products are distributed across various markets, including the Middle East, and they are actively expanding their presence in international markets.

Desloratadine

Desloratadine is a medication called antihistamine. Desloratadine is used to treat hay fever and allergy symptoms, including sneezing; runny nose; and red, itchy, tearing eyes in adults and children to relieve. It is also used to relieve symptoms of hives, the red, itchy raised areas of the skin, including itches and rashes. antihistamine works by blocking histamine, a substance in the body that causes allergic symptoms. Desloratadine is sold under the trade names Clarinex and Aerius to name a few. It was patented in 1984 and came into medical use in 2001. Merck Sharp Dohme makes Clarinex, a brand name of desloratadine, approved by the FDA in 2004. In the European union, the patent is held by Cipla limited, several other companies like TARO, Dr, Reddy’s also got approvals to launch their version of this product in other countries.

Forms and dose

Desloratadine comes as a tablet, oral solution (liquid), and an orally disintegrating tablet to take by mouth. It is taken once a day with or without food. The Usual Adult Dose for Allergic Rhinitis is 5 mg orally, once a day and for Urticaria too it is 5 mg orally once a day. In the treatment of Allergic Rhinitis, Usual Pediatric Dose for 6 to 11 months babies is 1 mg orally once a day and for kids aged 12 months to 5 years, it is 1.25 mg orally once a day. For growing kids between 6 to 11 years, the dose is 2.5 mg orally once a day and for kids older than 12 years and older, it is 5 mg orally once a day. The Usual Pediatric Dose for Urticaria for children age 6 to 11 months is 1 mg orally once a day, for kids 12 months to 5 years, the dose is 1.25 mg orally once a day. For kids between 6 to 11 years, it is 2.5 mg orally once a day and for kids 12 years and older the dose is 5 mg orally once a day.

The price of Desloratadine

In the USA, the consumers have to pay an average retail price of $112.22 for a supply of 30 tablets of 5mg strength. In the UK, the same supply costs significantly less at 45 pounds.

How does Desloratadine work

Desloratadine blocks a type of receptor for H1 and thus prevents activation of cells by histamine. Unlike other antihistamines, it does not enter the brain from the blood and, thus, does not cause drowsiness. Desloratadine’s actions block a certain natural substance (histamine) that your body makes during an allergic reaction.

Finding Desloratadine Manufacturers and Desloratadine Suppliers

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