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CEP/COS
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EDQM
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USP
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JP
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DRUG PRODUCT COMPOSITIONS
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
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ASMF
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
Anlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Together we can improve the quality of life
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USDMF
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
GDUFA
DMF Review : Complete
Rev. Date : 2024-12-17
Pay. Date : 2024-09-04
DMF Number : 38006
Submission : 2024-07-17
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-18
Pay. Date : 2023-07-06
DMF Number : 38204
Submission : 2023-03-29
Status :
Type : II
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API Imports and Exports
Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Ferinject
Dosage Form : INJ
Dosage Strength : 50mg/ml
Packaging : 10X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Solution for Injection...
Dosage Strength : 100MG/2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Solution for Injection...
Dosage Strength : 500MG/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Solution for Injection...
Dosage Strength : 750MG/15ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Solution for Injection...
Dosage Strength : 1000MG/20ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
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DATA COMPILATION #PharmaFlow
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Global Sales Information
Market Place
FDF DOSSIERS
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28 Mar 2023
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ABOUT THIS PAGE
69
PharmaCompass offers a list of Ferric Carboxymaltose 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 Carboxymaltose manufacturer or Ferric Carboxymaltose supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ferric Carboxymaltose manufacturer or Ferric Carboxymaltose supplier.
PharmaCompass also assists you with knowing the Ferric Carboxymaltose API Price utilized in the formulation of products. Ferric Carboxymaltose API Price is not always fixed or binding as the Ferric Carboxymaltose Price is obtained through a variety of data sources. The Ferric Carboxymaltose Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Injectafer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Injectafer, including repackagers and relabelers. The FDA regulates Injectafer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Injectafer 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 Injectafer manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Injectafer supplier is an individual or a company that provides Injectafer active pharmaceutical ingredient (API) or Injectafer finished formulations upon request. The Injectafer suppliers may include Injectafer API manufacturers, exporters, distributors and traders.
click here to find a list of Injectafer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Injectafer DMF (Drug Master File) is a document detailing the whole manufacturing process of Injectafer active pharmaceutical ingredient (API) in detail. Different forms of Injectafer DMFs exist exist since differing nations have different regulations, such as Injectafer USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Injectafer DMF submitted to regulatory agencies in the US is known as a USDMF. Injectafer USDMF includes data on Injectafer's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Injectafer USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Injectafer suppliers with USDMF on PharmaCompass.
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 Injectafer Drug Master File in Japan (Injectafer JDMF) empowers Injectafer 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 Injectafer JDMF during the approval evaluation for pharmaceutical products. At the time of Injectafer JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Injectafer suppliers with JDMF 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 Injectafer Drug Master File in Korea (Injectafer KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Injectafer. The MFDS reviews the Injectafer KDMF as part of the drug registration process and uses the information provided in the Injectafer KDMF to evaluate the safety and efficacy of the drug.
After submitting a Injectafer 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 Injectafer API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Injectafer suppliers with KDMF on PharmaCompass.
A Injectafer written confirmation (Injectafer WC) is an official document issued by a regulatory agency to a Injectafer manufacturer, verifying that the manufacturing facility of a Injectafer active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Injectafer APIs or Injectafer finished pharmaceutical products to another nation, regulatory agencies frequently require a Injectafer WC (written confirmation) as part of the regulatory process.
click here to find a list of Injectafer suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Injectafer as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Injectafer API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Injectafer as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Injectafer and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Injectafer NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Injectafer suppliers with NDC on PharmaCompass.
Injectafer 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 Injectafer 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 Injectafer GMP manufacturer or Injectafer GMP API supplier for your needs.
A Injectafer CoA (Certificate of Analysis) is a formal document that attests to Injectafer's compliance with Injectafer specifications and serves as a tool for batch-level quality control.
Injectafer CoA mostly includes findings from lab analyses of a specific batch. For each Injectafer 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.
Injectafer may be tested according to a variety of international standards, such as European Pharmacopoeia (Injectafer EP), Injectafer JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Injectafer USP).
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