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PharmaCompass offers a list of Allylestrenol 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 Allylestrenol manufacturer or Allylestrenol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Allylestrenol manufacturer or Allylestrenol supplier.
PharmaCompass also assists you with knowing the Allylestrenol API Price utilized in the formulation of products. Allylestrenol API Price is not always fixed or binding as the Allylestrenol Price is obtained through a variety of data sources. The Allylestrenol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Allylestrenol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Allylestrenol, including repackagers and relabelers. The FDA regulates Allylestrenol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Allylestrenol 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 Allylestrenol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Allylestrenol supplier is an individual or a company that provides Allylestrenol active pharmaceutical ingredient (API) or Allylestrenol finished formulations upon request. The Allylestrenol suppliers may include Allylestrenol API manufacturers, exporters, distributors and traders.
click here to find a list of Allylestrenol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Allylestrenol Drug Master File in Japan (Allylestrenol JDMF) empowers Allylestrenol 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 Allylestrenol JDMF during the approval evaluation for pharmaceutical products. At the time of Allylestrenol 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 Allylestrenol suppliers with JDMF on PharmaCompass.
A Allylestrenol written confirmation (Allylestrenol WC) is an official document issued by a regulatory agency to a Allylestrenol manufacturer, verifying that the manufacturing facility of a Allylestrenol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Allylestrenol APIs or Allylestrenol finished pharmaceutical products to another nation, regulatory agencies frequently require a Allylestrenol WC (written confirmation) as part of the regulatory process.
click here to find a list of Allylestrenol suppliers with Written Confirmation (WC) on PharmaCompass.
Allylestrenol 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 Allylestrenol 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 Allylestrenol GMP manufacturer or Allylestrenol GMP API supplier for your needs.
A Allylestrenol CoA (Certificate of Analysis) is a formal document that attests to Allylestrenol's compliance with Allylestrenol specifications and serves as a tool for batch-level quality control.
Allylestrenol CoA mostly includes findings from lab analyses of a specific batch. For each Allylestrenol 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.
Allylestrenol may be tested according to a variety of international standards, such as European Pharmacopoeia (Allylestrenol EP), Allylestrenol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Allylestrenol USP).