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