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