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Looking for 23383-11-1 / Ferric Citrate API manufacturers, exporters & distributors?

Ferric Citrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Ferric Citrate 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 Citrate manufacturer or Ferric Citrate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ferric Citrate manufacturer or Ferric Citrate supplier.

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

API | Excipient name

Ferric Citrate

Synonyms

Iron(iii) citrate, Iron citrate, 3522-50-7, Zerenex, 6043-74-9, 28633-45-6

Cas Number

23383-11-1

Unique Ingredient Identifier (UNII)

63G354M39Z

Ferric Citrate Manufacturers

A Ferric Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferric Citrate, including repackagers and relabelers. The FDA regulates Ferric Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferric Citrate 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 Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ferric Citrate Suppliers

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

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

Ferric Citrate USDMF

A Ferric Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ferric Citrate active pharmaceutical ingredient (API) in detail. Different forms of Ferric Citrate DMFs exist exist since differing nations have different regulations, such as Ferric Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Ferric Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Ferric Citrate USDMF includes data on Ferric Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ferric Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Ferric Citrate suppliers with USDMF on PharmaCompass.

Ferric Citrate 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 Citrate Drug Master File in Japan (Ferric Citrate JDMF) empowers Ferric Citrate 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 Citrate JDMF during the approval evaluation for pharmaceutical products. At the time of Ferric Citrate 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 Ferric Citrate suppliers with JDMF on PharmaCompass.

Ferric Citrate WC

A Ferric Citrate written confirmation (Ferric Citrate WC) is an official document issued by a regulatory agency to a Ferric Citrate manufacturer, verifying that the manufacturing facility of a Ferric Citrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ferric Citrate APIs or Ferric Citrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Ferric Citrate WC (written confirmation) as part of the regulatory process.

click here to find a list of Ferric Citrate suppliers with Written Confirmation (WC) on PharmaCompass.

Ferric Citrate GMP

Ferric Citrate 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 Citrate 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 Citrate GMP manufacturer or Ferric Citrate GMP API supplier for your needs.

Ferric Citrate CoA

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

Ferric Citrate CoA mostly includes findings from lab analyses of a specific batch. For each Ferric Citrate 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 Citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ferric Citrate EP), Ferric Citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ferric Citrate 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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