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PharmaCompass offers a list of Meglumine 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 Meglumine manufacturer or Meglumine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Meglumine manufacturer or Meglumine supplier.
PharmaCompass also assists you with knowing the Meglumine API Price utilized in the formulation of products. Meglumine API Price is not always fixed or binding as the Meglumine Price is obtained through a variety of data sources. The Meglumine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Meglumine, including repackagers and relabelers. The FDA regulates Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Meglumine 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 Meglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Meglumine supplier is an individual or a company that provides Meglumine active pharmaceutical ingredient (API) or Meglumine finished formulations upon request. The Meglumine suppliers may include Meglumine API manufacturers, exporters, distributors and traders.
click here to find a list of Meglumine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Meglumine DMF (Drug Master File) is a document detailing the whole manufacturing process of Meglumine active pharmaceutical ingredient (API) in detail. Different forms of Meglumine DMFs exist exist since differing nations have different regulations, such as Meglumine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Meglumine DMF submitted to regulatory agencies in the US is known as a USDMF. Meglumine USDMF includes data on Meglumine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Meglumine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Meglumine suppliers with USDMF 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 Meglumine Drug Master File in Korea (Meglumine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Meglumine. The MFDS reviews the Meglumine KDMF as part of the drug registration process and uses the information provided in the Meglumine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Meglumine 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 Meglumine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Meglumine suppliers with KDMF on PharmaCompass.
A Meglumine CEP of the European Pharmacopoeia monograph is often referred to as a Meglumine Certificate of Suitability (COS). The purpose of a Meglumine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Meglumine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Meglumine to their clients by showing that a Meglumine CEP has been issued for it. The manufacturer submits a Meglumine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Meglumine CEP holder for the record. Additionally, the data presented in the Meglumine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Meglumine DMF.
A Meglumine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Meglumine 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 Meglumine 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 Meglumine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Meglumine 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 Meglumine 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 Meglumine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Meglumine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Meglumine suppliers with NDC on PharmaCompass.
Meglumine 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 Meglumine 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 Meglumine GMP manufacturer or Meglumine GMP API supplier for your needs.
A Meglumine CoA (Certificate of Analysis) is a formal document that attests to Meglumine's compliance with Meglumine specifications and serves as a tool for batch-level quality control.
Meglumine CoA mostly includes findings from lab analyses of a specific batch. For each Meglumine 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.
Meglumine may be tested according to a variety of international standards, such as European Pharmacopoeia (Meglumine EP), Meglumine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Meglumine USP).
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