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API SUPPLIERS
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USDMF
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Ferrous Gluconate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferrous Gluconate, including repackagers and relabelers. The FDA regulates Ferrous Gluconate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferrous Gluconate 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 Ferrous Gluconate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ferrous Gluconate supplier is an individual or a company that provides Ferrous Gluconate active pharmaceutical ingredient (API) or Ferrous Gluconate finished formulations upon request. The Ferrous Gluconate suppliers may include Ferrous Gluconate API manufacturers, exporters, distributors and traders.
click here to find a list of Ferrous Gluconate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ferrous Gluconate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ferrous Gluconate active pharmaceutical ingredient (API) in detail. Different forms of Ferrous Gluconate DMFs exist exist since differing nations have different regulations, such as Ferrous Gluconate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ferrous Gluconate DMF submitted to regulatory agencies in the US is known as a USDMF. Ferrous Gluconate USDMF includes data on Ferrous Gluconate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ferrous Gluconate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ferrous Gluconate suppliers with USDMF on PharmaCompass.
A Ferrous Gluconate CEP of the European Pharmacopoeia monograph is often referred to as a Ferrous Gluconate Certificate of Suitability (COS). The purpose of a Ferrous Gluconate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ferrous Gluconate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ferrous Gluconate to their clients by showing that a Ferrous Gluconate CEP has been issued for it. The manufacturer submits a Ferrous Gluconate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ferrous Gluconate CEP holder for the record. Additionally, the data presented in the Ferrous Gluconate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ferrous Gluconate DMF.
A Ferrous Gluconate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ferrous Gluconate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Ferrous Gluconate suppliers with CEP (COS) 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 Ferrous Gluconate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ferrous Gluconate 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 Ferrous Gluconate 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 Ferrous Gluconate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ferrous Gluconate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ferrous Gluconate suppliers with NDC on PharmaCompass.
Ferrous Gluconate 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 Ferrous Gluconate 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 Ferrous Gluconate GMP manufacturer or Ferrous Gluconate GMP API supplier for your needs.
A Ferrous Gluconate CoA (Certificate of Analysis) is a formal document that attests to Ferrous Gluconate's compliance with Ferrous Gluconate specifications and serves as a tool for batch-level quality control.
Ferrous Gluconate CoA mostly includes findings from lab analyses of a specific batch. For each Ferrous Gluconate 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.
Ferrous Gluconate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ferrous Gluconate EP), Ferrous Gluconate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ferrous Gluconate USP).
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