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Also known as: 1345510-43-1, Iron(3+);(2s,3r,4r,5r)-6-[(2s,3r,4s,5s,6r)-3,4,5-trihydroxy-6-[[(2s,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxymethyl]oxan-2-yl]oxyhexane-1,2,3,4,5-pentol, Db15617
Molecular Formula
C18H34FeO16+3
Molecular Weight
562.3  g/mol
InChI Key
JTQTXQSGPZRXJF-DOJSGGEQSA-N

Ferric Derisomaltose
Ferric Derisomaltose is an iron carbohydrate complex composed of ferric hydroxide and the carbohydrate derisomaltose, that may be used for the treatment of iron deficiency anemia. Upon intravenous administration of ferric derisomaltose, ferric iron is released and binds to transferrin. Transferrin-bound iron is transported to erythroid precursor cells and incorporated into hemoglobin.
1 2D Structure

Ferric Derisomaltose

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
iron(3+);(2S,3R,4R,5R)-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-[[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxymethyl]oxan-2-yl]oxyhexane-1,2,3,4,5-pentol
2.1.2 InChI
InChI=1S/C18H34O16.Fe/c19-1-5(21)9(23)10(24)6(22)3-31-17-16(30)14(28)12(26)8(34-17)4-32-18-15(29)13(27)11(25)7(2-20)33-18;/h5-30H,1-4H2;/q;+3/t5-,6+,7+,8+,9+,10+,11+,12+,13-,14-,15+,16+,17-,18-;/m0./s1
2.1.3 InChI Key
JTQTXQSGPZRXJF-DOJSGGEQSA-N
2.1.4 Canonical SMILES
C(C1C(C(C(C(O1)OCC2C(C(C(C(O2)OCC(C(C(C(CO)O)O)O)O)O)O)O)O)O)O)O.[Fe+3]
2.1.5 Isomeric SMILES
C([C@@H]1[C@H]([C@@H]([C@H]([C@H](O1)OC[C@@H]2[C@H]([C@@H]([C@H]([C@H](O2)OC[C@H]([C@H]([C@@H]([C@H](CO)O)O)O)O)O)O)O)O)O)O)O.[Fe+3]
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. 1345510-43-1

2. Iron(3+);(2s,3r,4r,5r)-6-[(2s,3r,4s,5s,6r)-3,4,5-trihydroxy-6-[[(2s,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxymethyl]oxan-2-yl]oxyhexane-1,2,3,4,5-pentol

3. Db15617

2.3 Create Date
2014-11-22
3 Chemical and Physical Properties
Molecular Weight 562.3 g/mol
Molecular Formula C18H34FeO16+3
Hydrogen Bond Donor Count12
Hydrogen Bond Acceptor Count16
Rotatable Bond Count11
Exact Mass562.119621 g/mol
Monoisotopic Mass562.119621 g/mol
Topological Polar Surface Area280 Ų
Heavy Atom Count35
Formal Charge3
Complexity598
Isotope Atom Count0
Defined Atom Stereocenter Count14
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

This drug is indicated for the treatment of iron deficiency anemia in adult patients who have experienced intolerance to oral iron preparations or insufficient clinical response to orally administered iron. Ferric derisomaltase is also indicated for patients with non-hemodialysis dependent chronic kidney disease. In Australia and United Kingdom, ferric derisomaltase is indicated for cases in which rapid delivery of iron is required.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Ferric derisomaltase increases the reticulocyte count and ultimately increases hemoglobin, treating iron deficiency anemia and its various symptoms. Parenteral iron, such as ferric derisomaltose, may cause false elevations in serum bilirubin levels and falsely reduced serum calcium.


5.2 Absorption, Distribution and Excretion

Absorption

After a single 1000 mg dose, the Cmax and AUC of serum iron were 408 g/mL and 17730 g.h /mL, respectively. Serum ferritin concentrations reach their peak about 7 days after a single dose of intravenous ferric derisomaltose. A note on concomitant oral iron The absorption of oral iron is decreased when administered with intravenous iron. The administration of oral iron should be delayed until at least 5 days after the last ferric derisomaltose injection.


Route of Elimination

Renal elimination was not a significant route of elimination in single-dose pharmacokinetic studies. Iron can often accumulate in the body leading to iron overload followed by toxic effects. Small amounts of ferric derisomaltose are excreted in the urine and feces.


Volume of Distribution

Ferric derisomaltose or released iron that was released is found in cells of the reticuloendothelial system (RES). It is found to be highly concentrated in the liver and spleen. The volume of distribution of other forms of intravenous iron is 3L, on average, in a 70 kg adult. Though the specific volume of distribution of ferric derisomaltose is not readily available in the literature, it is likely similar to other intravenous forms of iron.


Clearance

Intravenous iron is cleared from the plasma. Ferric derisomaltose is not eliminated via the kidneys, as the size of the complex is large and cannot be excreted via the nephron.


5.3 Metabolism/Metabolites

Iron in the circulation is taken up by the plasma by cells of the RES. This binds proteins that form hemosiderin or ferritin, as well transferrin. Following this step, the bound iron replenishes low hemoglobin (Hb) and iron.


5.4 Biological Half-Life

The plasma-half live of intravenous iron is about 1-4 days.


5.5 Mechanism of Action

This drug is a complex made of iron (III) hydroxide and derisomaltose, which is an iron carbohydrate oligosaccharide that works to releases iron. The released iron then binds to the transport protein, transferrin, and is taken to erythroid precursor cells for incorporation into the hemoglobin molecule.


API SUPPLIERS

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Interquim SA

Spain

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Transo-Pharm USA LLC

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Pharmacosmos AS

Denmark

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Pharmacosmos AS

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Sichuan Huiyu Pharmaceutical

China

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Ferric delisomaltose

Registration Number : 302MF10143

Registrant's Address : Roervangsvej 30, DK-4300 Holbaek, Denmark

Initial Date of Registration : 2020-12-07

Latest Date of Registration : 2020-12-07

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Interquim SA

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Ferric Derisomaltose

About the Company : Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs...

Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs that meet stringent quality standards. Complying with European environmental and work safety regulations, Interquim’s products are exported to highly regulated pharmaceutical markets. Regulatory bodies and clients have approved its quality system and facilities. With state-of-the-art multi-production plants, drug synthesis, and quality-control labs, Interquim supports clients throughout the entire product lifecycle, from product development to marketing.
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About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...

Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout the entire API life cycle, from product development through sales. Transo-Pharm serves as a sourcing and regulatory marketing agent for API manufacturers. It aids clients in establishing DMFs and provides GMP consulting. With a dedicated regulatory department, a warehouse, proprietary IPs for API processes, and partnerships with laboratories, Transo-Pharm offers a wide range of services. It operates from its offices in Shanghai, Hong Kong, Singapore, and the US.
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Ferric Derisomaltose

About the Company : Huiyu Pharma, established in Oct. 2010, is a specialized pharmaceutical company focusing on developing and manufacturing high-quality oncology products. At present, products in our...

Huiyu Pharma, established in Oct. 2010, is a specialized pharmaceutical company focusing on developing and manufacturing high-quality oncology products. At present, products in our list include the following:Azacitidine, Bendamustine HCl, Bortezomib, Camptothecin, Carboplatin, Decitabine, Docetaxel, Doxorubicin HCl, Epirubicin HCl, Gemcitabine Hydrochloride, Irinotecan Hydrochloride, Methotrexate, Oxaliplatin, Paclitaxel, Pemetrexed disodium...We welcome those traders, distributors, and wholesalers who are interested in our products.
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Drugs in Development

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Details:

MonoFerric injection having Ferric derisomaltose, is a rapid, single dose intravenous therapy used for the treatment of iron deficiency in adult patients when oral iron preparations are ineffective or cannot be used.


Lead Product(s): Ferric Derisomaltose

Therapeutic Area: Hematology Brand Name: MonoFerric

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Zydus Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition September 09, 2022

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Pharmacosmos AS

Denmark
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Pharmacosmos AS

Denmark
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Details : MonoFerric injection having Ferric derisomaltose, is a rapid, single dose intravenous therapy used for the treatment of iron deficiency in adult patients when oral iron preparations are ineffective or cannot be used.

Product Name : MonoFerric

Product Type : Small molecule

Upfront Cash : Undisclosed

September 09, 2022

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Details:

Monofer® is the first of the latest generation of innovative IV irons to be made available to patients in the Chinese health care system and is expected to expand the use of IV irons across multiple therapeutic areas.


Lead Product(s): Ferric Derisomaltose

Therapeutic Area: Hematology Brand Name: Monofer

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 29, 2021

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Pharmacosmos AS

Denmark
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Pharmacosmos AS

Denmark
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Details : Monofer® is the first of the latest generation of innovative IV irons to be made available to patients in the Chinese health care system and is expected to expand the use of IV irons across multiple therapeutic areas.

Product Name : Monofer

Product Type : Small molecule

Upfront Cash : Not Applicable

January 29, 2021

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DOSAGE - SOLUTION;INTRAVENOUS - 100MG/ML (100...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/ML (100MG/ML)

USFDA APPLICATION NUMBER - 208171

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USFDA APPLICATION NUMBER - 208171

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Ferric Derisomaltose manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Ferric Derisomaltose API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ferric Derisomaltose manufacturer or Ferric Derisomaltose supplier for your needs.

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PharmaCompass also assists you with knowing the Ferric Derisomaltose API Price utilized in the formulation of products. Ferric Derisomaltose API Price is not always fixed or binding as the Ferric Derisomaltose Price is obtained through a variety of data sources. The Ferric Derisomaltose Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Ferric Derisomaltose

Synonyms

1345510-43-1, Iron(3+);(2s,3r,4r,5r)-6-[(2s,3r,4s,5s,6r)-3,4,5-trihydroxy-6-[[(2s,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxymethyl]oxan-2-yl]oxyhexane-1,2,3,4,5-pentol, Db15617

Cas Number

1345510-43-1

About Ferric Derisomaltose

Ferric Derisomaltose is an iron carbohydrate complex composed of ferric hydroxide and the carbohydrate derisomaltose, that may be used for the treatment of iron deficiency anemia. Upon intravenous administration of ferric derisomaltose, ferric iron is released and binds to transferrin. Transferrin-bound iron is transported to erythroid precursor cells and incorporated into hemoglobin.

Ferric Derisomaltose Manufacturers

A Ferric Derisomaltose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferric Derisomaltose, including repackagers and relabelers. The FDA regulates Ferric Derisomaltose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferric Derisomaltose API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Ferric Derisomaltose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ferric Derisomaltose Suppliers

A Ferric Derisomaltose supplier is an individual or a company that provides Ferric Derisomaltose active pharmaceutical ingredient (API) or Ferric Derisomaltose finished formulations upon request. The Ferric Derisomaltose suppliers may include Ferric Derisomaltose API manufacturers, exporters, distributors and traders.

click here to find a list of Ferric Derisomaltose suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Ferric Derisomaltose JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Ferric Derisomaltose Drug Master File in Japan (Ferric Derisomaltose JDMF) empowers Ferric Derisomaltose API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Ferric Derisomaltose JDMF during the approval evaluation for pharmaceutical products. At the time of Ferric Derisomaltose JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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Ferric Derisomaltose GMP

Ferric Derisomaltose Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Ferric Derisomaltose GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ferric Derisomaltose GMP manufacturer or Ferric Derisomaltose GMP API supplier for your needs.

Ferric Derisomaltose CoA

A Ferric Derisomaltose CoA (Certificate of Analysis) is a formal document that attests to Ferric Derisomaltose's compliance with Ferric Derisomaltose specifications and serves as a tool for batch-level quality control.

Ferric Derisomaltose CoA mostly includes findings from lab analyses of a specific batch. For each Ferric Derisomaltose CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Ferric Derisomaltose may be tested according to a variety of international standards, such as European Pharmacopoeia (Ferric Derisomaltose EP), Ferric Derisomaltose JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ferric Derisomaltose USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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