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