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ABOUT THIS PAGE
A Strontium-89 Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Strontium-89 Chloride, including repackagers and relabelers. The FDA regulates Strontium-89 Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Strontium-89 Chloride 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 Strontium-89 Chloride supplier is an individual or a company that provides Strontium-89 Chloride active pharmaceutical ingredient (API) or Strontium-89 Chloride finished formulations upon request. The Strontium-89 Chloride suppliers may include Strontium-89 Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Strontium-89 Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Strontium-89 Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Strontium-89 Chloride active pharmaceutical ingredient (API) in detail. Different forms of Strontium-89 Chloride DMFs exist exist since differing nations have different regulations, such as Strontium-89 Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Strontium-89 Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Strontium-89 Chloride USDMF includes data on Strontium-89 Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Strontium-89 Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Strontium-89 Chloride suppliers with USDMF on PharmaCompass.
Strontium-89 Chloride 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 Strontium-89 Chloride 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 Strontium-89 Chloride GMP manufacturer or Strontium-89 Chloride GMP API supplier for your needs.
A Strontium-89 Chloride CoA (Certificate of Analysis) is a formal document that attests to Strontium-89 Chloride's compliance with Strontium-89 Chloride specifications and serves as a tool for batch-level quality control.
Strontium-89 Chloride CoA mostly includes findings from lab analyses of a specific batch. For each Strontium-89 Chloride 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.
Strontium-89 Chloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Strontium-89 Chloride EP), Strontium-89 Chloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Strontium-89 Chloride USP).
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