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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 Carbonyl iron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carbonyl iron, including repackagers and relabelers. The FDA regulates Carbonyl iron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carbonyl 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 Carbonyl iron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Carbonyl iron supplier is an individual or a company that provides Carbonyl iron active pharmaceutical ingredient (API) or Carbonyl iron finished formulations upon request. The Carbonyl iron suppliers may include Carbonyl iron API manufacturers, exporters, distributors and traders.
click here to find a list of Carbonyl iron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carbonyl iron DMF (Drug Master File) is a document detailing the whole manufacturing process of Carbonyl iron active pharmaceutical ingredient (API) in detail. Different forms of Carbonyl iron DMFs exist exist since differing nations have different regulations, such as Carbonyl iron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carbonyl iron DMF submitted to regulatory agencies in the US is known as a USDMF. Carbonyl iron USDMF includes data on Carbonyl iron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carbonyl iron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carbonyl 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 Carbonyl iron Drug Master File in Japan (Carbonyl iron JDMF) empowers Carbonyl 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 Carbonyl iron JDMF during the approval evaluation for pharmaceutical products. At the time of Carbonyl 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 Carbonyl 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 Carbonyl iron Drug Master File in Korea (Carbonyl iron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Carbonyl iron. The MFDS reviews the Carbonyl iron KDMF as part of the drug registration process and uses the information provided in the Carbonyl iron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Carbonyl 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 Carbonyl iron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Carbonyl iron suppliers with KDMF on PharmaCompass.
Carbonyl 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 Carbonyl 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 Carbonyl iron GMP manufacturer or Carbonyl iron GMP API supplier for your needs.
A Carbonyl iron CoA (Certificate of Analysis) is a formal document that attests to Carbonyl iron's compliance with Carbonyl iron specifications and serves as a tool for batch-level quality control.
Carbonyl iron CoA mostly includes findings from lab analyses of a specific batch. For each Carbonyl 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.
Carbonyl iron may be tested according to a variety of international standards, such as European Pharmacopoeia (Carbonyl iron EP), Carbonyl iron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Carbonyl iron USP).
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