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