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