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