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