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USDMF
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ABOUT THIS PAGE
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PharmaCompass offers a list of Amorolfine Hydrochloride 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 Amorolfine Hydrochloride manufacturer or Amorolfine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amorolfine Hydrochloride manufacturer or Amorolfine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Amorolfine Hydrochloride API Price utilized in the formulation of products. Amorolfine Hydrochloride API Price is not always fixed or binding as the Amorolfine Hydrochloride Price is obtained through a variety of data sources. The Amorolfine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Curanail manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Curanail, including repackagers and relabelers. The FDA regulates Curanail manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Curanail 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 Curanail manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Curanail supplier is an individual or a company that provides Curanail active pharmaceutical ingredient (API) or Curanail finished formulations upon request. The Curanail suppliers may include Curanail API manufacturers, exporters, distributors and traders.
click here to find a list of Curanail suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Curanail DMF (Drug Master File) is a document detailing the whole manufacturing process of Curanail active pharmaceutical ingredient (API) in detail. Different forms of Curanail DMFs exist exist since differing nations have different regulations, such as Curanail USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Curanail DMF submitted to regulatory agencies in the US is known as a USDMF. Curanail USDMF includes data on Curanail's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Curanail USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Curanail 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 Curanail Drug Master File in Japan (Curanail JDMF) empowers Curanail 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 Curanail JDMF during the approval evaluation for pharmaceutical products. At the time of Curanail 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 Curanail 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 Curanail Drug Master File in Korea (Curanail KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Curanail. The MFDS reviews the Curanail KDMF as part of the drug registration process and uses the information provided in the Curanail KDMF to evaluate the safety and efficacy of the drug.
After submitting a Curanail 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 Curanail API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Curanail suppliers with KDMF on PharmaCompass.
A Curanail CEP of the European Pharmacopoeia monograph is often referred to as a Curanail Certificate of Suitability (COS). The purpose of a Curanail CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Curanail EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Curanail to their clients by showing that a Curanail CEP has been issued for it. The manufacturer submits a Curanail CEP (COS) as part of the market authorization procedure, and it takes on the role of a Curanail CEP holder for the record. Additionally, the data presented in the Curanail CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Curanail DMF.
A Curanail CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Curanail 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 Curanail suppliers with CEP (COS) on PharmaCompass.
A Curanail written confirmation (Curanail WC) is an official document issued by a regulatory agency to a Curanail manufacturer, verifying that the manufacturing facility of a Curanail active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Curanail APIs or Curanail finished pharmaceutical products to another nation, regulatory agencies frequently require a Curanail WC (written confirmation) as part of the regulatory process.
click here to find a list of Curanail suppliers with Written Confirmation (WC) on PharmaCompass.
Curanail 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 Curanail 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 Curanail GMP manufacturer or Curanail GMP API supplier for your needs.
A Curanail CoA (Certificate of Analysis) is a formal document that attests to Curanail's compliance with Curanail specifications and serves as a tool for batch-level quality control.
Curanail CoA mostly includes findings from lab analyses of a specific batch. For each Curanail 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.
Curanail may be tested according to a variety of international standards, such as European Pharmacopoeia (Curanail EP), Curanail JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Curanail USP).
