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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE;ORAL - 100MG
USFDA APPLICATION NUMBER - 19781
DOSAGE - CAPSULE;ORAL - 200MG
USFDA APPLICATION NUMBER - 19781
DOSAGE - GEL;VAGINAL - 4%
USFDA APPLICATION NUMBER - 20701
DOSAGE - GEL;VAGINAL - 8%
USFDA APPLICATION NUMBER - 20701
DOSAGE - CAPSULE;ORAL - 0.5MG;100MG
USFDA APPLICATION NUMBER - 210132
DOSAGE - CAPSULE;ORAL - 1MG;100MG
USFDA APPLICATION NUMBER - 210132
Related Excipient Companies
EUROAPI
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ABOUT THIS PAGE
49
PharmaCompass offers a list of Progesterone 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 Progesterone manufacturer or Progesterone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Progesterone manufacturer or Progesterone supplier.
PharmaCompass also assists you with knowing the Progesterone API Price utilized in the formulation of products. Progesterone API Price is not always fixed or binding as the Progesterone Price is obtained through a variety of data sources. The Progesterone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Progestan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Progestan, including repackagers and relabelers. The FDA regulates Progestan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Progestan 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 Progestan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Progestan supplier is an individual or a company that provides Progestan active pharmaceutical ingredient (API) or Progestan finished formulations upon request. The Progestan suppliers may include Progestan API manufacturers, exporters, distributors and traders.
click here to find a list of Progestan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Progestan DMF (Drug Master File) is a document detailing the whole manufacturing process of Progestan active pharmaceutical ingredient (API) in detail. Different forms of Progestan DMFs exist exist since differing nations have different regulations, such as Progestan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Progestan DMF submitted to regulatory agencies in the US is known as a USDMF. Progestan USDMF includes data on Progestan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Progestan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Progestan 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 Progestan Drug Master File in Japan (Progestan JDMF) empowers Progestan 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 Progestan JDMF during the approval evaluation for pharmaceutical products. At the time of Progestan 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 Progestan 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 Progestan Drug Master File in Korea (Progestan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Progestan. The MFDS reviews the Progestan KDMF as part of the drug registration process and uses the information provided in the Progestan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Progestan 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 Progestan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Progestan suppliers with KDMF on PharmaCompass.
A Progestan CEP of the European Pharmacopoeia monograph is often referred to as a Progestan Certificate of Suitability (COS). The purpose of a Progestan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Progestan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Progestan to their clients by showing that a Progestan CEP has been issued for it. The manufacturer submits a Progestan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Progestan CEP holder for the record. Additionally, the data presented in the Progestan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Progestan DMF.
A Progestan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Progestan 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 Progestan suppliers with CEP (COS) on PharmaCompass.
A Progestan written confirmation (Progestan WC) is an official document issued by a regulatory agency to a Progestan manufacturer, verifying that the manufacturing facility of a Progestan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Progestan APIs or Progestan finished pharmaceutical products to another nation, regulatory agencies frequently require a Progestan WC (written confirmation) as part of the regulatory process.
click here to find a list of Progestan 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 Progestan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Progestan 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 Progestan 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 Progestan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Progestan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Progestan suppliers with NDC on PharmaCompass.
Progestan 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 Progestan 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 Progestan GMP manufacturer or Progestan GMP API supplier for your needs.
A Progestan CoA (Certificate of Analysis) is a formal document that attests to Progestan's compliance with Progestan specifications and serves as a tool for batch-level quality control.
Progestan CoA mostly includes findings from lab analyses of a specific batch. For each Progestan 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.
Progestan may be tested according to a variety of international standards, such as European Pharmacopoeia (Progestan EP), Progestan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Progestan USP).
