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desloratadine Tablets 5 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #21631

This CTD dossier owner and manufacturer, established in Europe, specializes in the production of solid dosage forms. With several decades of experience, they have a robust track record in the industry, distributing their products to over 30 countries, particularly in regions like Africa, the Middle East, and Asia. The company has a strong focus on producing prescription drugs and boasts a significant production capacity, manufacturing millions of units annually. Their operations adhere to strict GMP standards, ensuring quality and compliance. While the company's specific therapy areas are not explicitly stated, their focus on solid dosage forms suggests a broad product portfolio. They have garnered a notable reputation for their expertise and commitment to providing high-quality pharmaceutical products.

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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