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