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  • TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 26159-34-2 / Naproxen Sodium API manufacturers, exporters & distributors?

Naproxen Sodium manufacturers, exporters & distributors 1


PharmaCompass offers a list of Naproxen 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 Naproxen Sodium manufacturer or Naproxen Sodium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Naproxen Sodium manufacturer or Naproxen Sodium supplier.

PharmaCompass also assists you with knowing the Naproxen Sodium API Price utilized in the formulation of products. Naproxen Sodium API Price is not always fixed or binding as the Naproxen Sodium Price is obtained through a variety of data sources. The Naproxen Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Naproxen Sodium


26159-34-2, Naprelan, Anaprox, Naproxen sodium salt, Miranax, (-)-naproxen sodium

Cas Number


Unique Ingredient Identifier (UNII)


About Naproxen Sodium

An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.

Naproxen Sodium Manufacturers

A Naproxen Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naproxen Sodium, including repackagers and relabelers. The FDA regulates Naproxen Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naproxen Sodium 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 Naproxen Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Naproxen Sodium Suppliers

A Naproxen Sodium supplier is an individual or a company that provides Naproxen Sodium active pharmaceutical ingredient (API) or Naproxen Sodium finished formulations upon request. The Naproxen Sodium suppliers may include Naproxen Sodium API manufacturers, exporters, distributors and traders.

click here to find a list of Naproxen Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Naproxen Sodium USDMF

A Naproxen Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Naproxen Sodium active pharmaceutical ingredient (API) in detail. Different forms of Naproxen Sodium DMFs exist exist since differing nations have different regulations, such as Naproxen Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Naproxen Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Naproxen Sodium USDMF includes data on Naproxen Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naproxen Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Naproxen Sodium suppliers with USDMF on PharmaCompass.

Naproxen Sodium KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Naproxen Sodium Drug Master File in Korea (Naproxen Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naproxen Sodium. The MFDS reviews the Naproxen Sodium KDMF as part of the drug registration process and uses the information provided in the Naproxen Sodium KDMF to evaluate the safety and efficacy of the drug.

After submitting a Naproxen Sodium 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 Naproxen Sodium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Naproxen Sodium suppliers with KDMF on PharmaCompass.

Naproxen Sodium CEP

A Naproxen Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Naproxen Sodium Certificate of Suitability (COS). The purpose of a Naproxen Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Naproxen Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Naproxen Sodium to their clients by showing that a Naproxen Sodium CEP has been issued for it. The manufacturer submits a Naproxen Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Naproxen Sodium CEP holder for the record. Additionally, the data presented in the Naproxen Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Naproxen Sodium DMF.

A Naproxen Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Naproxen Sodium 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 Naproxen Sodium suppliers with CEP (COS) on PharmaCompass.

Naproxen Sodium WC

A Naproxen Sodium written confirmation (Naproxen Sodium WC) is an official document issued by a regulatory agency to a Naproxen Sodium manufacturer, verifying that the manufacturing facility of a Naproxen Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naproxen Sodium APIs or Naproxen Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Naproxen Sodium WC (written confirmation) as part of the regulatory process.

click here to find a list of Naproxen Sodium suppliers with Written Confirmation (WC) on PharmaCompass.

Naproxen Sodium NDC

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 Naproxen Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Naproxen Sodium API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Naproxen Sodium 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Naproxen Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naproxen Sodium NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Naproxen Sodium suppliers with NDC on PharmaCompass.

Naproxen Sodium GMP

Naproxen Sodium 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 Naproxen Sodium 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 Naproxen Sodium GMP manufacturer or Naproxen Sodium GMP API supplier for your needs.

Naproxen Sodium CoA

A Naproxen Sodium CoA (Certificate of Analysis) is a formal document that attests to Naproxen Sodium's compliance with Naproxen Sodium specifications and serves as a tool for batch-level quality control.

Naproxen Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Naproxen Sodium 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.

Naproxen Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Naproxen Sodium EP), Naproxen Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naproxen Sodium USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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