Ferric Maltol

Global calcium is one of the leading manufacturers and exporters of ferric maltol CAS no. 33725-54-1, mineral actives . We support the customers with exhaustive documentation. As a USDMF & EU-GMP certified global company and an established hallmark for pharmaceutical standards, global calcium has stood the test of time since its inception in 1979.

As manufacturer of ferric maltol we hereby state the following facts about the drug:

Ferric maltol (FM) is a novel oral iron therapy based on a stable complex of ferric (Fe3+) iron with maltol a naturally occurring sugar derivative that has been used for many years as a food additive.

After oral ingestion of ferric maltol, ferric iron reaches the intestinal mucosa in complex form, which is believed to allow more efficient uptake of elemental ferric iron into enterocytes compared with ferrous iron salts.

Approvals

In july 2019, the food and drug administration (FDA) approved ferric maltol (FM) for the prescription treatment of iron deficiency in adults. FM has been approved for clinical use in the european union since 2016 to treat iron deficiency anemia (IDA) in adults.  Prior to the approval of FM, the second-line treatment recommended for patients who cannot tolerate oral iron salts included intravenous (IV) iron.

Pharmacokinetics

• The maltol complex increases the bioavailability of iron, allowing for the administration of lower elemental iron doses as compared with other iron formulations.
• Food has been shown to decrease iron bioavailability after FM administration.
• Maltol is rapidly metabolized to maltol glucuronide through sulfation with subsequent mean urinary excretion of 40% to 60% total ingested maltol as maltol glucuronide.
• After administration of ferric maltol at doses of 30, 60, and 90 mg twice daily, maltol is rapidly glucuronidated and excreted in the urine, while the iron is absorbed independently.
• Maltol pharmacokinetics are predictable after ferric maltol dosing up to 90 mg twice daily. It is well tolerated and demonstrates predictable pharmacokinetics with a consistent, good safety/tolerability profile.

Global calcium is a leading manufacturer of this drug. We manufacture this pharmaceutical drug and make it available to domestic and overseas market