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