X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
77
PharmaCompass offers a list of Pravastatin 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 Pravastatin manufacturer or Pravastatin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pravastatin manufacturer or Pravastatin supplier.
PharmaCompass also assists you with knowing the Pravastatin API Price utilized in the formulation of products. Pravastatin API Price is not always fixed or binding as the Pravastatin Price is obtained through a variety of data sources. The Pravastatin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Eptastatin sodium salt hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eptastatin sodium salt hydrate, including repackagers and relabelers. The FDA regulates Eptastatin sodium salt hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eptastatin sodium salt hydrate 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 Eptastatin sodium salt hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eptastatin sodium salt hydrate supplier is an individual or a company that provides Eptastatin sodium salt hydrate active pharmaceutical ingredient (API) or Eptastatin sodium salt hydrate finished formulations upon request. The Eptastatin sodium salt hydrate suppliers may include Eptastatin sodium salt hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Eptastatin sodium salt hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eptastatin sodium salt hydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Eptastatin sodium salt hydrate active pharmaceutical ingredient (API) in detail. Different forms of Eptastatin sodium salt hydrate DMFs exist exist since differing nations have different regulations, such as Eptastatin sodium salt hydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eptastatin sodium salt hydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Eptastatin sodium salt hydrate USDMF includes data on Eptastatin sodium salt hydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eptastatin sodium salt hydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eptastatin sodium salt hydrate 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 Eptastatin sodium salt hydrate Drug Master File in Japan (Eptastatin sodium salt hydrate JDMF) empowers Eptastatin sodium salt hydrate 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 Eptastatin sodium salt hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Eptastatin sodium salt hydrate 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 Eptastatin sodium salt hydrate 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 Eptastatin sodium salt hydrate Drug Master File in Korea (Eptastatin sodium salt hydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eptastatin sodium salt hydrate. The MFDS reviews the Eptastatin sodium salt hydrate KDMF as part of the drug registration process and uses the information provided in the Eptastatin sodium salt hydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eptastatin sodium salt hydrate 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 Eptastatin sodium salt hydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eptastatin sodium salt hydrate suppliers with KDMF on PharmaCompass.
A Eptastatin sodium salt hydrate CEP of the European Pharmacopoeia monograph is often referred to as a Eptastatin sodium salt hydrate Certificate of Suitability (COS). The purpose of a Eptastatin sodium salt hydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Eptastatin sodium salt hydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Eptastatin sodium salt hydrate to their clients by showing that a Eptastatin sodium salt hydrate CEP has been issued for it. The manufacturer submits a Eptastatin sodium salt hydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Eptastatin sodium salt hydrate CEP holder for the record. Additionally, the data presented in the Eptastatin sodium salt hydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Eptastatin sodium salt hydrate DMF.
A Eptastatin sodium salt hydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Eptastatin sodium salt hydrate 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 Eptastatin sodium salt hydrate suppliers with CEP (COS) on PharmaCompass.
A Eptastatin sodium salt hydrate written confirmation (Eptastatin sodium salt hydrate WC) is an official document issued by a regulatory agency to a Eptastatin sodium salt hydrate manufacturer, verifying that the manufacturing facility of a Eptastatin sodium salt hydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eptastatin sodium salt hydrate APIs or Eptastatin sodium salt hydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Eptastatin sodium salt hydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Eptastatin sodium salt hydrate 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 Eptastatin sodium salt hydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eptastatin sodium salt hydrate 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 Eptastatin sodium salt hydrate 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 Eptastatin sodium salt hydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eptastatin sodium salt hydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eptastatin sodium salt hydrate suppliers with NDC on PharmaCompass.
Eptastatin sodium salt hydrate 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 Eptastatin sodium salt hydrate 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 Eptastatin sodium salt hydrate GMP manufacturer or Eptastatin sodium salt hydrate GMP API supplier for your needs.
A Eptastatin sodium salt hydrate CoA (Certificate of Analysis) is a formal document that attests to Eptastatin sodium salt hydrate's compliance with Eptastatin sodium salt hydrate specifications and serves as a tool for batch-level quality control.
Eptastatin sodium salt hydrate CoA mostly includes findings from lab analyses of a specific batch. For each Eptastatin sodium salt hydrate 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.
Eptastatin sodium salt hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Eptastatin sodium salt hydrate EP), Eptastatin sodium salt hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eptastatin sodium salt hydrate USP).
Market Place
