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Ferric hydroxide polymaltose manufacturers

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Country of origin : Brazil

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ferric hydroxide polymaltose

Solution for injection 20 mg/mL

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Brazil
GMP approvals
ANVISA
Manufacturer #17642
This is a known company that operates in the wholesale trade of pharmaceutical products for human as well as veterinary use. The company's portfolio includes high-quality drugs that combine with the best of its return and output at the same time.

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FERRIC HYDROXIDE POLYMALTOSE

Ferric Hydroxide Polymaltose, also called Iron (III)-hydroxide polymaltose complex, is from a group of oral iron preparations that prevent and treat iron deficiency and iron-deficiency anaemia. Ferric Hydroxide Polymaltose is a macromolecular complex that has iron (III)-hydroxide, also called trivalent iron, and the carrier polymaltose. It is used for treating iron deficiency without anaemia called latent iron deficiency or with anaemia when the individual has an apparent iron deficiency. The iron deficiency is diagnostically established and verified by testing for low ferritin concentration or low transferrin saturation.

An estimated two billion people worldwide suffer from iron deficiency. It is one of the most common nutrient deficiencies around the world including developed countries. In the longer run, when the populations start falling short on iron and with lack of corrective dosing whole populations can experience fatigue, weakened immunity, poor work performance, and a decreased quality of life. Infants with IDA achieve lower scores on mental and motor development tests. Children and women are amongst the populations at the highest risk of developing these deficiencies. Ferric Hydroxide Polymaltose is sold in many countries under the brand name Maltofer(R). it is made and sold by companies around the world, so there are several brands, manufacturers of this medicine around the world.

Simon L Ruskin filed the first patent back in the 1950s. R K Laros Company, then in 1959 was assigned the FDA license for Dextran-iron complex and process for making the same. Since then several makers have been assigned several patents. Ferric Hydroxide Polymaltose has been sold since 1978 and is approved for sale in over 85 countries.

Forms and Dosage

Ferric Hydroxide Polymaltose preparation is available in various formulations like syrup, drops, drinkable solution, film-coated tablets, and chewable tablets. The formulations of syrup drop, or drinkable solution are specifically for children. While the dose is according to age, the following are the general dosage guidelines for iron deficiency with anaemia. In Premature babies, the dose is 2.5–5 mg per kilo of bodyweight. Children up to 1 year of age, the recommended intake is 25–50 mg and for Children 1–12 years of age, the dose is 50–100 mg. The dose for young people aged 12 and above, and for adults and pregnant women is 100–300 mg per day.

The price of Ferric Hydroxide Polymaltose

On the international market depending on the grade and purpose, the wholesale price can vary between US$6 to US$25 per kilo of the ingredient grade. The price of 10 tabs of 100mg cost US$0.7 in India.

How does Ferric Hydroxide Polymaltose work?

The iron administered in the form of iron polymaltose complex. It is then utilized and absorbed by the erythrocytes and is absorbed in the intestines. This increases the relative absorption levels, these levels decrease with high doses and the severity of the iron deficiency, the greater the Absorption.

Finding Ferric Hydroxide Polymaltose Manufacturers and Suppliers

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