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DOSAGE - INJECTABLE;INJECTION - 10MG/ML
USFDA APPLICATION NUMBER - 9402
DOSAGE - INJECTABLE;INJECTION - 20MG/ML
USFDA APPLICATION NUMBER - 9402
DOSAGE - INJECTABLE;INJECTION - 40MG/ML
USFDA APPLICATION NUMBER - 9402
Related Excipient Companies
Nanjing Well Pharmaceutical
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ANALYTICAL
ABOUT THIS PAGE
A Estradiol Valerate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol Valerate, including repackagers and relabelers. The FDA regulates Estradiol Valerate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol Valerate 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 Estradiol Valerate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estradiol Valerate supplier is an individual or a company that provides Estradiol Valerate active pharmaceutical ingredient (API) or Estradiol Valerate finished formulations upon request. The Estradiol Valerate suppliers may include Estradiol Valerate API manufacturers, exporters, distributors and traders.
click here to find a list of Estradiol Valerate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Estradiol Valerate DMF (Drug Master File) is a document detailing the whole manufacturing process of Estradiol Valerate active pharmaceutical ingredient (API) in detail. Different forms of Estradiol Valerate DMFs exist exist since differing nations have different regulations, such as Estradiol Valerate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estradiol Valerate DMF submitted to regulatory agencies in the US is known as a USDMF. Estradiol Valerate USDMF includes data on Estradiol Valerate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estradiol Valerate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Estradiol Valerate 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 Estradiol Valerate Drug Master File in Japan (Estradiol Valerate JDMF) empowers Estradiol Valerate 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 Estradiol Valerate JDMF during the approval evaluation for pharmaceutical products. At the time of Estradiol Valerate 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 Estradiol Valerate 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 Estradiol Valerate Drug Master File in Korea (Estradiol Valerate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Estradiol Valerate. The MFDS reviews the Estradiol Valerate KDMF as part of the drug registration process and uses the information provided in the Estradiol Valerate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Estradiol Valerate 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 Estradiol Valerate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Estradiol Valerate suppliers with KDMF on PharmaCompass.
A Estradiol Valerate CEP of the European Pharmacopoeia monograph is often referred to as a Estradiol Valerate Certificate of Suitability (COS). The purpose of a Estradiol Valerate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Estradiol Valerate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Estradiol Valerate to their clients by showing that a Estradiol Valerate CEP has been issued for it. The manufacturer submits a Estradiol Valerate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Estradiol Valerate CEP holder for the record. Additionally, the data presented in the Estradiol Valerate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Estradiol Valerate DMF.
A Estradiol Valerate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Estradiol Valerate 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 Estradiol Valerate suppliers with CEP (COS) on PharmaCompass.
A Estradiol Valerate written confirmation (Estradiol Valerate WC) is an official document issued by a regulatory agency to a Estradiol Valerate manufacturer, verifying that the manufacturing facility of a Estradiol Valerate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Estradiol Valerate APIs or Estradiol Valerate finished pharmaceutical products to another nation, regulatory agencies frequently require a Estradiol Valerate WC (written confirmation) as part of the regulatory process.
click here to find a list of Estradiol Valerate 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 Estradiol Valerate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Estradiol Valerate 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 Estradiol Valerate 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 Estradiol Valerate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Estradiol Valerate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Estradiol Valerate suppliers with NDC on PharmaCompass.
Estradiol Valerate 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 Estradiol Valerate 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 Estradiol Valerate GMP manufacturer or Estradiol Valerate GMP API supplier for your needs.
A Estradiol Valerate CoA (Certificate of Analysis) is a formal document that attests to Estradiol Valerate's compliance with Estradiol Valerate specifications and serves as a tool for batch-level quality control.
Estradiol Valerate CoA mostly includes findings from lab analyses of a specific batch. For each Estradiol Valerate 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.
Estradiol Valerate may be tested according to a variety of international standards, such as European Pharmacopoeia (Estradiol Valerate EP), Estradiol Valerate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Estradiol Valerate USP).
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