X
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
76
PharmaCompass offers a list of Estradiol 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 Estradiol manufacturer or Estradiol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Estradiol manufacturer or Estradiol supplier.
PharmaCompass also assists you with knowing the Estradiol API Price utilized in the formulation of products. Estradiol API Price is not always fixed or binding as the Estradiol Price is obtained through a variety of data sources. The Estradiol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Estrogens, esterified manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estrogens, esterified, including repackagers and relabelers. The FDA regulates Estrogens, esterified manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estrogens, esterified 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 Estrogens, esterified manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estrogens, esterified supplier is an individual or a company that provides Estrogens, esterified active pharmaceutical ingredient (API) or Estrogens, esterified finished formulations upon request. The Estrogens, esterified suppliers may include Estrogens, esterified API manufacturers, exporters, distributors and traders.
click here to find a list of Estrogens, esterified suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Estrogens, esterified DMF (Drug Master File) is a document detailing the whole manufacturing process of Estrogens, esterified active pharmaceutical ingredient (API) in detail. Different forms of Estrogens, esterified DMFs exist exist since differing nations have different regulations, such as Estrogens, esterified USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estrogens, esterified DMF submitted to regulatory agencies in the US is known as a USDMF. Estrogens, esterified USDMF includes data on Estrogens, esterified's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estrogens, esterified USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Estrogens, esterified 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 Estrogens, esterified Drug Master File in Japan (Estrogens, esterified JDMF) empowers Estrogens, esterified 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 Estrogens, esterified JDMF during the approval evaluation for pharmaceutical products. At the time of Estrogens, esterified 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 Estrogens, esterified 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 Estrogens, esterified Drug Master File in Korea (Estrogens, esterified KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Estrogens, esterified. The MFDS reviews the Estrogens, esterified KDMF as part of the drug registration process and uses the information provided in the Estrogens, esterified KDMF to evaluate the safety and efficacy of the drug.
After submitting a Estrogens, esterified 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 Estrogens, esterified API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Estrogens, esterified suppliers with KDMF on PharmaCompass.
A Estrogens, esterified CEP of the European Pharmacopoeia monograph is often referred to as a Estrogens, esterified Certificate of Suitability (COS). The purpose of a Estrogens, esterified CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Estrogens, esterified EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Estrogens, esterified to their clients by showing that a Estrogens, esterified CEP has been issued for it. The manufacturer submits a Estrogens, esterified CEP (COS) as part of the market authorization procedure, and it takes on the role of a Estrogens, esterified CEP holder for the record. Additionally, the data presented in the Estrogens, esterified CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Estrogens, esterified DMF.
A Estrogens, esterified CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Estrogens, esterified 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 Estrogens, esterified suppliers with CEP (COS) on PharmaCompass.
A Estrogens, esterified written confirmation (Estrogens, esterified WC) is an official document issued by a regulatory agency to a Estrogens, esterified manufacturer, verifying that the manufacturing facility of a Estrogens, esterified active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Estrogens, esterified APIs or Estrogens, esterified finished pharmaceutical products to another nation, regulatory agencies frequently require a Estrogens, esterified WC (written confirmation) as part of the regulatory process.
click here to find a list of Estrogens, esterified 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 Estrogens, esterified as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Estrogens, esterified 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 Estrogens, esterified 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 Estrogens, esterified and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Estrogens, esterified NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Estrogens, esterified suppliers with NDC on PharmaCompass.
Estrogens, esterified 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 Estrogens, esterified 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 Estrogens, esterified GMP manufacturer or Estrogens, esterified GMP API supplier for your needs.
A Estrogens, esterified CoA (Certificate of Analysis) is a formal document that attests to Estrogens, esterified's compliance with Estrogens, esterified specifications and serves as a tool for batch-level quality control.
Estrogens, esterified CoA mostly includes findings from lab analyses of a specific batch. For each Estrogens, esterified 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.
Estrogens, esterified may be tested according to a variety of international standards, such as European Pharmacopoeia (Estrogens, esterified EP), Estrogens, esterified JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Estrogens, esterified USP).
Market Place
