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simethicone Oral drops 40 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Israel
GMP approvals
EU GMP
Manufacturer #21635

This CTD dossier owner and manufacturer has been a leading force in the Middle East region for over a century, establishing a strong reputation for providing health solutions. They operate in both healthcare and agriculture, with a focus on the development, production, and marketing of prescription and over-the-counter medications, supplements, and medical devices. They have a strong track record of export activities, particularly in Asia, Africa, and Europe. Their production adheres to stringent international quality standards, including GMP certification. They engage in both in-licensing and out-licensing agreements to expand their product portfolio. Key therapy areas include oncology, cardiology, and rare diseases. Dosage forms include solids, liquids, and injectables.

SIMETHICONE

Simethicone is an anti-foaming agent that helps relieve symptoms of gas such as painful or uncomfortable or pressure, fullness, or bloating. In the digestive tract, its actions decrease the surface tension of gas bubbles, causing them to form larger bubbles. However, it is to be noted that it cannot reduce or prevent gas formation in the digestive tract. Eventually, it provides relief from symptoms of excessive gas, like bloating, burping and flatulence.

Simethicone is sold, under the Brand names like Alka-Seltzer® Anti-Gas, Colic Drops, Colicon®, Degas®, Flatulex® Drops, amongst others. Mcneil-Ppc, Inc. filed the first patent for making this medicine in 1997 for their Simethicone/ anhydrous calcium phosphate compositions. Later, Shire Laboratories, Inc. also filed for patents in 1999 followed by Panacea Biotec Ltd in 2005 for the specific formulations and preparations.

Forms and Dosage:

Simethicone is available as Liquid Filled Capsule, Chewable Tablet, Suspension, Tablet and Solution. The tablets are chewable; however, the capsules are to be swallowed whole. In the treatment of Dyspepsia, the Usual Adult Dose, when taken Chewable Tablets is 80 to 160 mg, to be taken orally. If taking the Extra Strength 125 mg Capsules, the recommended dose is 125 to 250 mg. When taking the Ultra Strength 180 mg, the dose is 180 to 360 mg and finally, if taking the Maximum Strength 250 mg Capsules, the dose is 250 to 500 mg. the maximum dose is capped at 500mg per day.

While controlling or treating Flatulence, the recommended Usual Adult Dose if taking Chewable Tablets is, 80 to 160 mg, or if taking Extra Strength 125 mg Capsules, the dose is 125 to 250 mg. If taking Ultra Strength 180 mg Capsules the dose is 180 to 360 mg and when taking the Maximum Strength 250 mg Capsules the recommended dose is 250 to 500 mg, taken orally once after a meal.

The price of Simethicone:

In the USA, the consumers must pay an average retail price of $5.00 for 30 generic chewable tablets of 80mg. In India, the imported version of 30 chewable tablets of 80mg, sold OTC is around USD10. The generic drug makers 30 tablets of 80mg could be bought for less than US$1.

How does Simethicone work?

Simethicone is a silicone compound that works like a non-systemic surfactant. These compounds decrease the surface tension of gas bubbles in the GI tract. The resulting outcome is a coalescence and dispersion of the gas bubbles, which makes it easy to dispel from the GI tract in flatulence or belching. Overall, its actions make it easy for the patients to pass gas from the body thus reducing the pain or pressure from the gas in the tract.

Finding Simethicone Manufacturers and Suppliers

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