X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
0
Europe
Canada
0
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
65
PharmaCompass offers a list of Iron 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 manufacturer or Iron supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Iron manufacturer or Iron supplier.
PharmaCompass also assists you with knowing the Iron API Price utilized in the formulation of products. Iron API Price is not always fixed or binding as the Iron Price is obtained through a variety of data sources. The Iron Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Iron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iron, including repackagers and relabelers. The FDA regulates Iron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iron 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 Iron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iron supplier is an individual or a company that provides Iron active pharmaceutical ingredient (API) or Iron finished formulations upon request. The Iron suppliers may include Iron API manufacturers, exporters, distributors and traders.
click here to find a list of Iron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iron DMF (Drug Master File) is a document detailing the whole manufacturing process of Iron active pharmaceutical ingredient (API) in detail. Different forms of Iron DMFs exist exist since differing nations have different regulations, such as Iron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iron DMF submitted to regulatory agencies in the US is known as a USDMF. Iron USDMF includes data on Iron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iron 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 Iron Drug Master File in Japan (Iron JDMF) empowers Iron 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 Iron JDMF during the approval evaluation for pharmaceutical products. At the time of Iron 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 Iron 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 Iron Drug Master File in Korea (Iron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Iron. The MFDS reviews the Iron KDMF as part of the drug registration process and uses the information provided in the Iron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Iron 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 Iron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Iron suppliers with KDMF on PharmaCompass.
Iron 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 Iron 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 Iron GMP manufacturer or Iron GMP API supplier for your needs.
A Iron CoA (Certificate of Analysis) is a formal document that attests to Iron's compliance with Iron specifications and serves as a tool for batch-level quality control.
Iron CoA mostly includes findings from lab analyses of a specific batch. For each Iron 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.
Iron may be tested according to a variety of international standards, such as European Pharmacopoeia (Iron EP), Iron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Iron USP).
Market Place
