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