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Looking for 164650-44-6 / Efinaconazole API manufacturers, exporters & distributors?

Efinaconazole manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Efinaconazole

Synonyms

164650-44-6, (2r,3r)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1h-1,2,4-triazol-1-yl)butan-2-ol, Kp-103, Jublia, Clenafin, Kp103

Cas Number

164650-44-6

Unique Ingredient Identifier (UNII)

J82SB7FXWB

About Efinaconazole

Efinaconazole is a triazole compound, with antifungal activity. Upon administration, efinaconazole targets, binds to and inhibits 14-alpha-demethylase, a cytochrome P450-dependent enzyme. Inhibition of 14-alpha-demethylase prevents the conversion of lanosterol to ergosterol, an important component of the fungal cell wall. Inhibition of ergosterol synthesis changes the fungal cell membrane composition and integrity, alters membrane permeability and eventually leads to fungal cell lysis.

Efinaconazole Manufacturers

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

Efinaconazole Suppliers

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

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

Efinaconazole USDMF

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

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

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

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

Efinaconazole KDMF

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

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

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

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

Efinaconazole WC

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

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

Efinaconazole 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 Efinaconazole as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Efinaconazole GMP

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

Efinaconazole CoA

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

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

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