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VMF
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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API SUPPLIERS
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Minakem is manufacturing small molecules APIs including corticosteroids
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Jai Radhe Sales is your partner for all your sourcing needs.
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
CEP/COS
JDMF
NDC
KDMF
CA, ASMF
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
EU-WC
KDMF
BR, RU
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
BR, RU
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USDMF
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-13
DMF Number : 7617
Submission : 1988-08-02
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
INTERMEDIATE SUPPLIERS
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
2-Butyl-3-(4-hydroxybenzoyl)benzofuran
CAS Number : 52490-15-0
End Use API : Amiodarone Hydrochloride
About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...
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REF. STANDARDS & IMPURITIES
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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 Ritmocardyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ritmocardyl, including repackagers and relabelers. The FDA regulates Ritmocardyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ritmocardyl 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 Ritmocardyl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ritmocardyl supplier is an individual or a company that provides Ritmocardyl active pharmaceutical ingredient (API) or Ritmocardyl finished formulations upon request. The Ritmocardyl suppliers may include Ritmocardyl API manufacturers, exporters, distributors and traders.
click here to find a list of Ritmocardyl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ritmocardyl DMF (Drug Master File) is a document detailing the whole manufacturing process of Ritmocardyl active pharmaceutical ingredient (API) in detail. Different forms of Ritmocardyl DMFs exist exist since differing nations have different regulations, such as Ritmocardyl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ritmocardyl DMF submitted to regulatory agencies in the US is known as a USDMF. Ritmocardyl USDMF includes data on Ritmocardyl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ritmocardyl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ritmocardyl 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 Ritmocardyl Drug Master File in Japan (Ritmocardyl JDMF) empowers Ritmocardyl 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 Ritmocardyl JDMF during the approval evaluation for pharmaceutical products. At the time of Ritmocardyl 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 Ritmocardyl 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 Ritmocardyl Drug Master File in Korea (Ritmocardyl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ritmocardyl. The MFDS reviews the Ritmocardyl KDMF as part of the drug registration process and uses the information provided in the Ritmocardyl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ritmocardyl 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 Ritmocardyl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ritmocardyl suppliers with KDMF on PharmaCompass.
A Ritmocardyl CEP of the European Pharmacopoeia monograph is often referred to as a Ritmocardyl Certificate of Suitability (COS). The purpose of a Ritmocardyl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ritmocardyl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ritmocardyl to their clients by showing that a Ritmocardyl CEP has been issued for it. The manufacturer submits a Ritmocardyl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ritmocardyl CEP holder for the record. Additionally, the data presented in the Ritmocardyl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ritmocardyl DMF.
A Ritmocardyl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ritmocardyl 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 Ritmocardyl suppliers with CEP (COS) on PharmaCompass.
A Ritmocardyl written confirmation (Ritmocardyl WC) is an official document issued by a regulatory agency to a Ritmocardyl manufacturer, verifying that the manufacturing facility of a Ritmocardyl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ritmocardyl APIs or Ritmocardyl finished pharmaceutical products to another nation, regulatory agencies frequently require a Ritmocardyl WC (written confirmation) as part of the regulatory process.
click here to find a list of Ritmocardyl 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 Ritmocardyl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ritmocardyl 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 Ritmocardyl 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 Ritmocardyl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ritmocardyl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ritmocardyl suppliers with NDC on PharmaCompass.
Ritmocardyl 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 Ritmocardyl 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 Ritmocardyl GMP manufacturer or Ritmocardyl GMP API supplier for your needs.
A Ritmocardyl CoA (Certificate of Analysis) is a formal document that attests to Ritmocardyl's compliance with Ritmocardyl specifications and serves as a tool for batch-level quality control.
Ritmocardyl CoA mostly includes findings from lab analyses of a specific batch. For each Ritmocardyl 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.
Ritmocardyl may be tested according to a variety of international standards, such as European Pharmacopoeia (Ritmocardyl EP), Ritmocardyl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ritmocardyl USP).
