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