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ABOUT THIS PAGE
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PharmaCompass offers a list of Milrinone 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 Milrinone manufacturer or Milrinone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Milrinone manufacturer or Milrinone supplier.
PharmaCompass also assists you with knowing the Milrinone API Price utilized in the formulation of products. Milrinone API Price is not always fixed or binding as the Milrinone Price is obtained through a variety of data sources. The Milrinone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Primacor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Primacor, including repackagers and relabelers. The FDA regulates Primacor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Primacor 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 Primacor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Primacor supplier is an individual or a company that provides Primacor active pharmaceutical ingredient (API) or Primacor finished formulations upon request. The Primacor suppliers may include Primacor API manufacturers, exporters, distributors and traders.
click here to find a list of Primacor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Primacor DMF (Drug Master File) is a document detailing the whole manufacturing process of Primacor active pharmaceutical ingredient (API) in detail. Different forms of Primacor DMFs exist exist since differing nations have different regulations, such as Primacor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Primacor DMF submitted to regulatory agencies in the US is known as a USDMF. Primacor USDMF includes data on Primacor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Primacor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Primacor 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 Primacor Drug Master File in Japan (Primacor JDMF) empowers Primacor 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 Primacor JDMF during the approval evaluation for pharmaceutical products. At the time of Primacor 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 Primacor suppliers with JDMF 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 Primacor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Primacor 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 Primacor 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 Primacor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Primacor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Primacor suppliers with NDC on PharmaCompass.
Primacor 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 Primacor 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 Primacor GMP manufacturer or Primacor GMP API supplier for your needs.
A Primacor CoA (Certificate of Analysis) is a formal document that attests to Primacor's compliance with Primacor specifications and serves as a tool for batch-level quality control.
Primacor CoA mostly includes findings from lab analyses of a specific batch. For each Primacor 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.
Primacor may be tested according to a variety of international standards, such as European Pharmacopoeia (Primacor EP), Primacor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Primacor USP).
