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