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PharmaCompass offers a list of NAFTIFINE HCL 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 NAFTIFINE HCL manufacturer or NAFTIFINE HCL supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred NAFTIFINE HCL manufacturer or NAFTIFINE HCL supplier.
PharmaCompass also assists you with knowing the NAFTIFINE HCL API Price utilized in the formulation of products. NAFTIFINE HCL API Price is not always fixed or binding as the NAFTIFINE HCL Price is obtained through a variety of data sources. The NAFTIFINE HCL Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Naftifine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naftifine, including repackagers and relabelers. The FDA regulates Naftifine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naftifine 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 Naftifine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naftifine supplier is an individual or a company that provides Naftifine active pharmaceutical ingredient (API) or Naftifine finished formulations upon request. The Naftifine suppliers may include Naftifine API manufacturers, exporters, distributors and traders.
click here to find a list of Naftifine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Naftifine DMF (Drug Master File) is a document detailing the whole manufacturing process of Naftifine active pharmaceutical ingredient (API) in detail. Different forms of Naftifine DMFs exist exist since differing nations have different regulations, such as Naftifine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naftifine DMF submitted to regulatory agencies in the US is known as a USDMF. Naftifine USDMF includes data on Naftifine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naftifine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naftifine suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Naftifine Drug Master File in Korea (Naftifine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naftifine. The MFDS reviews the Naftifine KDMF as part of the drug registration process and uses the information provided in the Naftifine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Naftifine 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 Naftifine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Naftifine suppliers with KDMF on PharmaCompass.
A Naftifine written confirmation (Naftifine WC) is an official document issued by a regulatory agency to a Naftifine manufacturer, verifying that the manufacturing facility of a Naftifine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naftifine APIs or Naftifine finished pharmaceutical products to another nation, regulatory agencies frequently require a Naftifine WC (written confirmation) as part of the regulatory process.
click here to find a list of Naftifine suppliers with Written Confirmation (WC) on PharmaCompass.
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 Naftifine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Naftifine API and other APIs are published in this directory by the FDA.
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 Naftifine 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.
The NDC directory also contains data on finished compounded human drug products that contain Naftifine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naftifine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Naftifine suppliers with NDC on PharmaCompass.
Naftifine 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 Naftifine 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 Naftifine GMP manufacturer or Naftifine GMP API supplier for your needs.
A Naftifine CoA (Certificate of Analysis) is a formal document that attests to Naftifine's compliance with Naftifine specifications and serves as a tool for batch-level quality control.
Naftifine CoA mostly includes findings from lab analyses of a specific batch. For each Naftifine 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.
Naftifine may be tested according to a variety of international standards, such as European Pharmacopoeia (Naftifine EP), Naftifine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naftifine USP).