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USDMF
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DOSAGE - CREAM;TOPICAL - 1%
USFDA APPLICATION NUMBER - 20524
DOSAGE - CREAM;TOPICAL - 1%
USFDA APPLICATION NUMBER - 21307
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PharmaCompass offers a list of Butenafine 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 Butenafine manufacturer or Butenafine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Butenafine manufacturer or Butenafine supplier.
PharmaCompass also assists you with knowing the Butenafine API Price utilized in the formulation of products. Butenafine API Price is not always fixed or binding as the Butenafine Price is obtained through a variety of data sources. The Butenafine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride, including repackagers and relabelers. The FDA regulates N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine 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 N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride supplier is an individual or a company that provides N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride active pharmaceutical ingredient (API) or N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride finished formulations upon request. The N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride suppliers may include N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride DMFs exist exist since differing nations have different regulations, such as N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride USDMF includes data on N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine 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 N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride Drug Master File in Japan (N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride JDMF) empowers N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine 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 N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine 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 N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine 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 N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride Drug Master File in Korea (N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride. The MFDS reviews the N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride KDMF as part of the drug registration process and uses the information provided in the N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine 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 N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine 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 N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine 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 N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine 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 N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride suppliers with NDC on PharmaCompass.
N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine 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 N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine 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 N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride GMP manufacturer or N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride GMP API supplier for your needs.
A N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride CoA (Certificate of Analysis) is a formal document that attests to N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride's compliance with N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride specifications and serves as a tool for batch-level quality control.
N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine 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.
N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride EP), N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (N-4-tert-butylbenzyl-N-methyl-1-naphthalene methylamine hydrochloride USP).
