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