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