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