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Looking for 2398-96-1 / Tolnaftate API manufacturers, exporters & distributors?

Tolnaftate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Tolnaftate

Synonyms

2398-96-1, Tinactin, Tonoftal, Tolnaphthate, Sporiline, Tinaderm

Cas Number

2398-96-1

Unique Ingredient Identifier (UNII)

06KB629TKV

About Tolnaftate

A synthetic antifungal agent.

Tolnaftate Manufacturers

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

Tolnaftate Suppliers

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

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

Tolnaftate USDMF

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

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

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

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

Tolnaftate CEP

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

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

Tolnaftate WC

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

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

Tolnaftate 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 Tolnaftate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Tolnaftate GMP

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

Tolnaftate CoA

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

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

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