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  • CREAM;TOPICAL - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • AEROSOL, FOAM;TOPICAL - 1%

Looking for 68797-31-9 / Econazole Nitrate API manufacturers, exporters & distributors?

Econazole Nitrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Econazole Nitrate 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 Econazole Nitrate manufacturer or Econazole Nitrate supplier for your needs.

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

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

API | Excipient name

Econazole Nitrate

Synonyms

24169-02-6, Ifenec, 68797-31-9, Pevaryl, Spectazole, Epi-pevaryl

Cas Number

68797-31-9

Unique Ingredient Identifier (UNII)

H438WYN10E

About Econazole Nitrate

An imidazole derivative that is commonly used as a topical antifungal agent.

Econazole Nitrate Manufacturers

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

Econazole Nitrate Suppliers

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

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

Econazole Nitrate USDMF

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

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

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

Econazole Nitrate CEP

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

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

Econazole Nitrate WC

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

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

Econazole Nitrate 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 Econazole Nitrate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Econazole Nitrate GMP

Econazole Nitrate 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 Econazole Nitrate 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 Econazole Nitrate GMP manufacturer or Econazole Nitrate GMP API supplier for your needs.

Econazole Nitrate CoA

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

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

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