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  • TABLET;ORAL - 250MG
  • TABLET;ORAL - 375MG
  • TABLET;ORAL - 500MG
  • SUSPENSION;ORAL - 25MG/ML
  • TABLET, DELAYED RELEASE;ORAL - 375MG
  • TABLET, DELAYED RELEASE;ORAL - 500MG
  • TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 22204-53-1 / Naproxen API manufacturers, exporters & distributors?

Naproxen manufacturers, exporters & distributors 1

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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.

API | Excipient name

Naproxen

Synonyms

22204-53-1, (s)-naproxen, Naprosyn, (+)-naproxen, Equiproxen, Naproxene

Cas Number

22204-53-1

Unique Ingredient Identifier (UNII)

57Y76R9ATQ

About Naproxen

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.

Alpron Manufacturers

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

Alpron Suppliers

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

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

Alpron USDMF

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

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

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

Alpron JDMF

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 Alpron Drug Master File in Japan (Alpron JDMF) empowers Alpron 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 Alpron JDMF during the approval evaluation for pharmaceutical products. At the time of Alpron 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 Alpron suppliers with JDMF on PharmaCompass.

Alpron KDMF

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

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

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

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

Alpron CEP

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

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

Alpron WC

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

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

Alpron 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 Alpron as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Alpron 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 Alpron 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 Alpron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alpron NDC to their finished compounded human drug products, they may choose to do so.

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

Alpron GMP

Alpron 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 Alpron 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 Alpron GMP manufacturer or Alpron GMP API supplier for your needs.

Alpron CoA

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

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

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