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