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