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API SUPPLIERS
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ABOUT THIS PAGE
A Alprostadil Alfadex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alprostadil Alfadex, including repackagers and relabelers. The FDA regulates Alprostadil Alfadex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alprostadil Alfadex 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 Alprostadil Alfadex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alprostadil Alfadex supplier is an individual or a company that provides Alprostadil Alfadex active pharmaceutical ingredient (API) or Alprostadil Alfadex finished formulations upon request. The Alprostadil Alfadex suppliers may include Alprostadil Alfadex API manufacturers, exporters, distributors and traders.
click here to find a list of Alprostadil Alfadex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alprostadil Alfadex DMF (Drug Master File) is a document detailing the whole manufacturing process of Alprostadil Alfadex active pharmaceutical ingredient (API) in detail. Different forms of Alprostadil Alfadex DMFs exist exist since differing nations have different regulations, such as Alprostadil Alfadex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alprostadil Alfadex DMF submitted to regulatory agencies in the US is known as a USDMF. Alprostadil Alfadex USDMF includes data on Alprostadil Alfadex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alprostadil Alfadex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alprostadil Alfadex 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 Alprostadil Alfadex Drug Master File in Japan (Alprostadil Alfadex JDMF) empowers Alprostadil Alfadex 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 Alprostadil Alfadex JDMF during the approval evaluation for pharmaceutical products. At the time of Alprostadil Alfadex 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 Alprostadil Alfadex suppliers with JDMF on PharmaCompass.
Alprostadil Alfadex 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 Alprostadil Alfadex 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 Alprostadil Alfadex GMP manufacturer or Alprostadil Alfadex GMP API supplier for your needs.
A Alprostadil Alfadex CoA (Certificate of Analysis) is a formal document that attests to Alprostadil Alfadex's compliance with Alprostadil Alfadex specifications and serves as a tool for batch-level quality control.
Alprostadil Alfadex CoA mostly includes findings from lab analyses of a specific batch. For each Alprostadil Alfadex 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.
Alprostadil Alfadex may be tested according to a variety of international standards, such as European Pharmacopoeia (Alprostadil Alfadex EP), Alprostadil Alfadex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alprostadil Alfadex USP).
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