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