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1. Ferric Hydroxide-polymaltose
2. Ferric Polymaltose
3. Ferripolyisomaltose
4. Ferrum Hausmann
5. Intrafer
6. Iron Hydroxide Polymaltose
7. Iron(iii)-hydroxide-dextrin
8. Iron-polymaltose Complex
9. Noripurum
10. Teferrol
1. Ferrummate
2. Amylofer
3. Maltofer
4. Ferripel 3
5. 53858-86-9
6. Um5219h89v
7. Teferrol
8. Ferrum Hausmann
9. Iron(3+);(2r,3s,4r,5r)-2,3,4,5-tetrahydroxy-6-[(2s,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide
10. Injectafer
11. Ferinject
12. Ferripel-3
13. Ferromaltose
14. Unii-um5219h89v
15. Ferric Hydroxide Polymaltose Complex
16. Iron(iii)-hydroxide Polymaltose Complex
17. Ferric Hydroxide Polymaltose Complex [who-dd]
18. Q27291136
Molecular Weight | 449.16 g/mol |
---|---|
Molecular Formula | C12H25FeO14 |
Hydrogen Bond Donor Count | 11 |
Hydrogen Bond Acceptor Count | 14 |
Rotatable Bond Count | 8 |
Exact Mass | 449.059366 g/mol |
Monoisotopic Mass | 449.059366 g/mol |
Topological Polar Surface Area | 200 Ų |
Heavy Atom Count | 27 |
Formal Charge | 0 |
Complexity | 367 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 9 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 5 |
Hematinics
Agents which improve the quality of the blood, increasing the hemoglobin level and the number of erythrocytes. They are used in the treatment of anemias. (See all compounds classified as Hematinics.)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33717
Submission : 2019-05-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33716
Submission : 2019-04-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32220
Submission : 2017-10-31
Status : Active
Type : II
Date of Issue : 2022-04-05
Valid Till : 2025-07-28
Written Confirmation Number : WC-0449A1
Address of the Firm : 75/2 National Highway No 6, Malkapur Dist. Buldana Malkapur 433 101
iron hydroxide polymaltose/ Iron protein succinylate
Date of Issue : 2019-07-29
Valid Till : 2022-07-28
Written Confirmation Number : WC-0449
Address of the Firm : 75/2 National Highway No 6 Malkapur
Date of Issue : 2021-01-08
Valid Till : 2025-01-08
Written Confirmation Number : WC-0490A2
Address of the Firm : Block No 63, Bileshwarpura, P.O Chhatral,\r\nKalol-Mehsana Highway, Gandhinagar-...
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Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
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ABOUT THIS PAGE
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PharmaCompass offers a list of Iron III Hydroxide Polymaltose Complex 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 Iron III Hydroxide Polymaltose Complex manufacturer or Iron III Hydroxide Polymaltose Complex supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Iron III Hydroxide Polymaltose Complex manufacturer or Iron III Hydroxide Polymaltose Complex supplier.
PharmaCompass also assists you with knowing the Iron III Hydroxide Polymaltose Complex API Price utilized in the formulation of products. Iron III Hydroxide Polymaltose Complex API Price is not always fixed or binding as the Iron III Hydroxide Polymaltose Complex Price is obtained through a variety of data sources. The Iron III Hydroxide Polymaltose Complex Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Intrafer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Intrafer, including repackagers and relabelers. The FDA regulates Intrafer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Intrafer 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 Intrafer manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Intrafer supplier is an individual or a company that provides Intrafer active pharmaceutical ingredient (API) or Intrafer finished formulations upon request. The Intrafer suppliers may include Intrafer API manufacturers, exporters, distributors and traders.
click here to find a list of Intrafer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Intrafer DMF (Drug Master File) is a document detailing the whole manufacturing process of Intrafer active pharmaceutical ingredient (API) in detail. Different forms of Intrafer DMFs exist exist since differing nations have different regulations, such as Intrafer USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Intrafer DMF submitted to regulatory agencies in the US is known as a USDMF. Intrafer USDMF includes data on Intrafer's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Intrafer USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Intrafer suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Intrafer Drug Master File in Korea (Intrafer KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Intrafer. The MFDS reviews the Intrafer KDMF as part of the drug registration process and uses the information provided in the Intrafer KDMF to evaluate the safety and efficacy of the drug.
After submitting a Intrafer KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Intrafer API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Intrafer suppliers with KDMF on PharmaCompass.
A Intrafer written confirmation (Intrafer WC) is an official document issued by a regulatory agency to a Intrafer manufacturer, verifying that the manufacturing facility of a Intrafer active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Intrafer APIs or Intrafer finished pharmaceutical products to another nation, regulatory agencies frequently require a Intrafer WC (written confirmation) as part of the regulatory process.
click here to find a list of Intrafer suppliers with Written Confirmation (WC) on PharmaCompass.
Intrafer 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 Intrafer 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 Intrafer GMP manufacturer or Intrafer GMP API supplier for your needs.
A Intrafer CoA (Certificate of Analysis) is a formal document that attests to Intrafer's compliance with Intrafer specifications and serves as a tool for batch-level quality control.
Intrafer CoA mostly includes findings from lab analyses of a specific batch. For each Intrafer 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.
Intrafer may be tested according to a variety of international standards, such as European Pharmacopoeia (Intrafer EP), Intrafer JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Intrafer USP).