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  • TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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Looking for 65277-42-1 / Ketoconazole API manufacturers, exporters & distributors?

Ketoconazole manufacturers, exporters & distributors 1


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

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

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

API | Excipient name



(+)-ketoconazole, 65277-42-1, (2r,4s)-ketoconazole, 142128-59-4, Kuric, Ketocanazole

Cas Number


About Ketoconazole

Broad spectrum antifungal agent used for long periods at high doses, especially in immunosuppressed patients.

Ketoconazole Manufacturers

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

Ketoconazole Suppliers

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

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

Ketoconazole USDMF

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

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

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

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

Ketoconazole KDMF

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

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

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

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

Ketoconazole CEP

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

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

Ketoconazole WC

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

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

Ketoconazole 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 Ketoconazole as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Ketoconazole GMP

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

Ketoconazole CoA

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

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

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