X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
15
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 Zetia manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zetia, including repackagers and relabelers. The FDA regulates Zetia manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zetia 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 Zetia manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zetia supplier is an individual or a company that provides Zetia active pharmaceutical ingredient (API) or Zetia finished formulations upon request. The Zetia suppliers may include Zetia API manufacturers, exporters, distributors and traders.
click here to find a list of Zetia suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zetia DMF (Drug Master File) is a document detailing the whole manufacturing process of Zetia active pharmaceutical ingredient (API) in detail. Different forms of Zetia DMFs exist exist since differing nations have different regulations, such as Zetia USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zetia DMF submitted to regulatory agencies in the US is known as a USDMF. Zetia USDMF includes data on Zetia's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zetia USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zetia 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 Zetia Drug Master File in Japan (Zetia JDMF) empowers Zetia 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 Zetia JDMF during the approval evaluation for pharmaceutical products. At the time of Zetia 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 Zetia 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 Zetia Drug Master File in Korea (Zetia KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zetia. The MFDS reviews the Zetia KDMF as part of the drug registration process and uses the information provided in the Zetia KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zetia 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 Zetia API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zetia suppliers with KDMF on PharmaCompass.
A Zetia written confirmation (Zetia WC) is an official document issued by a regulatory agency to a Zetia manufacturer, verifying that the manufacturing facility of a Zetia active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zetia APIs or Zetia finished pharmaceutical products to another nation, regulatory agencies frequently require a Zetia WC (written confirmation) as part of the regulatory process.
click here to find a list of Zetia 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 Zetia as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zetia 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 Zetia 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 Zetia and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zetia NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zetia suppliers with NDC on PharmaCompass.
Zetia 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 Zetia 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 Zetia GMP manufacturer or Zetia GMP API supplier for your needs.
A Zetia CoA (Certificate of Analysis) is a formal document that attests to Zetia's compliance with Zetia specifications and serves as a tool for batch-level quality control.
Zetia CoA mostly includes findings from lab analyses of a specific batch. For each Zetia 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.
Zetia may be tested according to a variety of international standards, such as European Pharmacopoeia (Zetia EP), Zetia JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zetia USP).
Market Place
