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Country of origin : India
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doxofylline

Tablets 400 mg, 800 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #20350

This company is a leading manufacturer of injectable and ophthalmic formulations, specializing in Beta Lactam and Cephalosporin products. They have a strong commitment to quality and compliance with international GMP standards (WHO-GMP & ISO 9001 : 2015). Their manufacturing facilities are dedicated to producing high-quality tablets, capsules, dry syrups, ointments, and sachets. They have a dedicated R&D center focused on innovation and export their products to over 30 countries. The company emphasizes sustainable manufacturing practices and environmental responsibility. Their client base includes hospitals, clinics, pharmacies, and government bodies across the globe.

Manufacturer usually replies in 13 days

doxofylline

Tablets 400 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #18273
India-based pharmaceutical company focused on supplying Rx generics to sub-Saharan African and other emerging healthcare markets. Oral solids, liquids, and semi-solids cover essential therapy areas including infections, malaria, and general medicine aligned with WHO guidelines. Quality-compliant manufacturing is aligned with regulatory requirements of target African markets.

Manufacturer usually replies in 15 days

doxofylline

Tablets 400 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #38861
India-based pharmaceutical formulations company manufacturing Rx generic oral solids, liquids, and semi-solids for domestic and regulated export markets. Dosage forms span infections, metabolic, and cardiovascular therapy areas aligned with Indian and international GMP standards. Committed to quality manufacturing and compliance for multi-market pharmaceutical distribution.

Manufacturer usually replies in 84 days

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Doxofylline

Doxofylline is a new kind of Bronchodilator that is a Methyl xanthine derivative. It treats COPD, asthma, and bronchospasm, inhibit platelet-activating factor and generation of leukotriene production. Structurally, Doxofylline differs from Theophylline as the dioxolane group in Doxofylline is in position 7. Doxofylline select and then inhibits phosphodiesterase 4. The resulting benefit the relaxing of bronchial smooth muscle. Even though different, it still has low affinities toward adenosine A1 and A2 receptors, giving the drug, a better safety profile. Doxofylline is reported to be marketed under many brand names like Xiva, An Li Nuo Er, An Sai Ma worldwide by several manufacturers. Alistair Pharmaceuticals demonstrated efficacy similar to theophylline but with significantly fewer side effects in 2013. By 2014, it received an orphan drug designation to doxofylline for the treatment of bronchiectasis by the US FDA.

Dosage & Administration

Doxofylline is available as 200 and 400mg tablets and sustained-release tablets. The standard adult dose for the Elderly is 200 mg tablets, taken 2 to 3 times a day. For adults, the dose is set at 400 mg tablet, taken 2 to 3 times, or as directed by the physician. In treating children, the dose for kids younger than 12 years of age is 10 ml syrup or 200 mg tablets, taken 2 to 3 times a day. For kids between 6-12 years of age, the dose is 6-9 mg for every kg of body weight, taken 2 to 3 times a day. For a body weight of 10 kg, a dose of 3 ml or 60 mg is prescribed. When the daily dose needed is 400 mg, the user can take the SR tablet, once a day.

The cost of Doxofylline

In the USA, the consumer pay USD43 for a supply of 60 tablets of 400mg. In India, the retail cost of 60 tablets of 400 mg, the same quantity as in the USA will cost around USD8.

How does Doxofylline Work?

Although its main mechanism of action is unclear, it is thought to inhibit phosphodiesterase activity in turn lifting cAMP levels and promoting smooth muscle relaxation. Doxofylline Interaction with beta-2 adrenoceptors, Serine 169, and serine 173 residues in the receptor critical binding sites. This is where the hydrogen bonds are formed by mediating actions of beta-2 adrenoceptors, Doxofylline stimulates blood vessel relaxation and airway smooth muscle relaxation. It may also have anti-inflammatory actions in decreasing pleurisy induced by the inflammatory mediator platelet-activating factor in animal studies.

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