US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Cinacalcet 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 Cinacalcet manufacturer or Cinacalcet supplier for your needs.
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PharmaCompass also assists you with knowing the Cinacalcet API Price utilized in the formulation of products. Cinacalcet API Price is not always fixed or binding as the Cinacalcet Price is obtained through a variety of data sources. The Cinacalcet Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cinacalcet manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cinacalcet, including repackagers and relabelers. The FDA regulates Cinacalcet manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cinacalcet 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 Cinacalcet manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cinacalcet supplier is an individual or a company that provides Cinacalcet active pharmaceutical ingredient (API) or Cinacalcet finished formulations upon request. The Cinacalcet suppliers may include Cinacalcet API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Cinacalcet suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cinacalcet DMF (Drug Master File) is a document detailing the whole manufacturing process of Cinacalcet active pharmaceutical ingredient (API) in detail. Different forms of Cinacalcet DMFs exist exist since differing nations have different regulations, such as Cinacalcet USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cinacalcet DMF submitted to regulatory agencies in the US is known as a USDMF. Cinacalcet USDMF includes data on Cinacalcet's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cinacalcet USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Cinacalcet Drug Master File in Japan (Cinacalcet JDMF) empowers Cinacalcet 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 Cinacalcet JDMF during the approval evaluation for pharmaceutical products. At the time of Cinacalcet JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Cinacalcet Drug Master File in Korea (Cinacalcet KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cinacalcet. The MFDS reviews the Cinacalcet KDMF as part of the drug registration process and uses the information provided in the Cinacalcet KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cinacalcet 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 Cinacalcet API can apply through the Korea Drug Master File (KDMF).
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A Cinacalcet written confirmation (Cinacalcet WC) is an official document issued by a regulatory agency to a Cinacalcet manufacturer, verifying that the manufacturing facility of a Cinacalcet active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cinacalcet APIs or Cinacalcet finished pharmaceutical products to another nation, regulatory agencies frequently require a Cinacalcet WC (written confirmation) as part of the regulatory process.
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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 Cinacalcet as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cinacalcet 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 Cinacalcet 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 Cinacalcet and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cinacalcet NDC to their finished compounded human drug products, they may choose to do so.
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Cinacalcet 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 Cinacalcet 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 Cinacalcet GMP manufacturer or Cinacalcet GMP API supplier for your needs.
A Cinacalcet CoA (Certificate of Analysis) is a formal document that attests to Cinacalcet's compliance with Cinacalcet specifications and serves as a tool for batch-level quality control.
Cinacalcet CoA mostly includes findings from lab analyses of a specific batch. For each Cinacalcet 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.
Cinacalcet may be tested according to a variety of international standards, such as European Pharmacopoeia (Cinacalcet EP), Cinacalcet JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cinacalcet USP).