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guaifenesin Syrup 100 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Philippines
GMP approvals
Philippines
Manufacturer #21232

This CTD dossier owner and manufacturer specializes in manufacturing both generic and branded pharmaceuticals, boasting a 30-year track record of quality production. Their state-of-the-art facilities are strategically located within an industrial zone in Southeast Asia, allowing them to produce a wide range of products across various therapy areas, including prescription medications, over-the-counter drugs, and potentially medical devices or supplements (information on these is limited). While specific product patents and GMP certifications aren't mentioned, their commitment to quality manufacturing is evident. They operate primarily in Southeast Asia, with potential expansion into other regions like North America and the EU based on industry trends.

Guaifenesin

Guaifenesin, an expectorant, helps loosen congestion in chest and throat, making it easier to cough out thick mucus or phlegm from the airways. It is also combined with dextromethorphan, a cough suppressant or with ephedrine to medicines for symptomatic relief from asthma. Overall, it is used to reduce chest congestion caused by the common cold, infections, or allergies. Its actions as an expectorant it keeps the respiratory tract effectively hydrated and maintains the sol layer that is needed for ciliary clearance. It also reduces the viscosity of respiratory mucus, which makes it easy for the body to expel the mucus or phlegm more easily in the natural body process.

Guaifenesin is sold under the brand name Mucinex among others. Guaifenesin is extracted from a tree bark extract called guaiacum. This bark has historically been used as an expectorant in the Caribbean region and adopted by European explorers in the 16the century. But it was not till 1952, that the first medical preparations got their approvals from the FDA in the USA. However, it took a further 20 years before, it was synthesized into tablets for medication.

Forms and Dosage

Guaifenesin is administered orally as pills or syrups. It is sold under several brand names in Single-ingredient formulations and also an ingredient in many other over-the-counter cough and cold remedy. For treating cough in adults, the recommended usual dose of the Immediate release formulation is 200 to 400 mg, taken orally every 4 hours as needed. When taking the Sustained release formulation, the recommended dose is 600 to 1200 mg orally every 12 hours. The dose for children suffering from cough, of the Immediate release formulation is 12 mg/kg/day orally in 6 divided doses for kids less than 2 years old. For kids in the age group of 2 to 5 years, the dose is 50 to 100 mg, for kids 6 to 11 years, the dose is 100 to 200 mg, taken orally every 4 hours and finally for kids 12 years or older, the dose is 200 to 400 mg taken orally every 4 hours. The pediatric dose for the sustained release formulation for kids 2 to 5 years old is 300 mg, twice a day, for kids 6 to 11 years, the dose is 600 mg and for kids 12 years or older the dose is 600 to 1200 mg.

The price of Guaifenesin

In the United States, the consumer has to pay a wholesale of US$0.10 per dose. This is a relatively inexpensive medicine in any part of the world. In India, the supply of 10 tablets of 200mg cost US$1.5.

How does it work?

Guaifenesin properties make it good expectorant. It does this by increasing the volume and reducing the viscosity of secretions in the bronchi and trachea. As a result, it aids in the smooth flow of respiratory tract secretions. The smoother flow allows for ciliary movement to carry the loosened secretions upward toward the pharynx. Eventually, increasing the efficiency of the cough reflex that facilitates removal of the secretions. It also has muscle relaxant and anticonvulsant properties in addition to being an NMDA receptor antagonist.

Finding Guaifenesin Manufacturers and Suppliers

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