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API SUPPLIERS
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USDMF
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API Imports and Exports
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Amorolfine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amorolfine, including repackagers and relabelers. The FDA regulates Amorolfine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amorolfine 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 Amorolfine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amorolfine supplier is an individual or a company that provides Amorolfine active pharmaceutical ingredient (API) or Amorolfine finished formulations upon request. The Amorolfine suppliers may include Amorolfine API manufacturers, exporters, distributors and traders.
click here to find a list of Amorolfine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amorolfine DMF (Drug Master File) is a document detailing the whole manufacturing process of Amorolfine active pharmaceutical ingredient (API) in detail. Different forms of Amorolfine DMFs exist exist since differing nations have different regulations, such as Amorolfine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amorolfine DMF submitted to regulatory agencies in the US is known as a USDMF. Amorolfine USDMF includes data on Amorolfine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amorolfine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amorolfine 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 Amorolfine Drug Master File in Japan (Amorolfine JDMF) empowers Amorolfine 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 Amorolfine JDMF during the approval evaluation for pharmaceutical products. At the time of Amorolfine 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 Amorolfine 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 Amorolfine Drug Master File in Korea (Amorolfine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Amorolfine. The MFDS reviews the Amorolfine KDMF as part of the drug registration process and uses the information provided in the Amorolfine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Amorolfine 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 Amorolfine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Amorolfine suppliers with KDMF on PharmaCompass.
A Amorolfine CEP of the European Pharmacopoeia monograph is often referred to as a Amorolfine Certificate of Suitability (COS). The purpose of a Amorolfine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amorolfine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amorolfine to their clients by showing that a Amorolfine CEP has been issued for it. The manufacturer submits a Amorolfine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amorolfine CEP holder for the record. Additionally, the data presented in the Amorolfine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amorolfine DMF.
A Amorolfine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amorolfine 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 Amorolfine suppliers with CEP (COS) on PharmaCompass.
A Amorolfine written confirmation (Amorolfine WC) is an official document issued by a regulatory agency to a Amorolfine manufacturer, verifying that the manufacturing facility of a Amorolfine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Amorolfine APIs or Amorolfine finished pharmaceutical products to another nation, regulatory agencies frequently require a Amorolfine WC (written confirmation) as part of the regulatory process.
click here to find a list of Amorolfine suppliers with Written Confirmation (WC) on PharmaCompass.
Amorolfine 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 Amorolfine 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 Amorolfine GMP manufacturer or Amorolfine GMP API supplier for your needs.
A Amorolfine CoA (Certificate of Analysis) is a formal document that attests to Amorolfine's compliance with Amorolfine specifications and serves as a tool for batch-level quality control.
Amorolfine CoA mostly includes findings from lab analyses of a specific batch. For each Amorolfine 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.
Amorolfine may be tested according to a variety of international standards, such as European Pharmacopoeia (Amorolfine EP), Amorolfine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amorolfine USP).
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