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DOSAGE - CREAM;TOPICAL - 1%
USFDA APPLICATION NUMBER - 20524
DOSAGE - CREAM;TOPICAL - 1%
USFDA APPLICATION NUMBER - 21307
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ABOUT THIS PAGE
A Butenafine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butenafine Hydrochloride, including repackagers and relabelers. The FDA regulates Butenafine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butenafine Hydrochloride 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 Butenafine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Butenafine Hydrochloride supplier is an individual or a company that provides Butenafine Hydrochloride active pharmaceutical ingredient (API) or Butenafine Hydrochloride finished formulations upon request. The Butenafine Hydrochloride suppliers may include Butenafine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Butenafine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Butenafine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Butenafine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Butenafine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Butenafine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Butenafine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Butenafine Hydrochloride USDMF includes data on Butenafine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Butenafine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Butenafine Hydrochloride suppliers with USDMF on PharmaCompass.
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 Butenafine Hydrochloride Drug Master File in Japan (Butenafine Hydrochloride JDMF) empowers Butenafine Hydrochloride 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 Butenafine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Butenafine Hydrochloride 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 Butenafine Hydrochloride suppliers with JDMF 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 Butenafine Hydrochloride Drug Master File in Korea (Butenafine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Butenafine Hydrochloride. The MFDS reviews the Butenafine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Butenafine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Butenafine Hydrochloride 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 Butenafine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Butenafine Hydrochloride suppliers with KDMF 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 Butenafine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Butenafine Hydrochloride 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 Butenafine Hydrochloride 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 Butenafine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Butenafine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Butenafine Hydrochloride suppliers with NDC on PharmaCompass.
Butenafine Hydrochloride 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 Butenafine Hydrochloride 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 Butenafine Hydrochloride GMP manufacturer or Butenafine Hydrochloride GMP API supplier for your needs.
A Butenafine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Butenafine Hydrochloride's compliance with Butenafine Hydrochloride specifications and serves as a tool for batch-level quality control.
Butenafine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Butenafine Hydrochloride 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.
Butenafine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Butenafine Hydrochloride EP), Butenafine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Butenafine Hydrochloride USP).
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