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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION;ORAL - 3.5-150mCi/VIAL
USFDA APPLICATION NUMBER - 16515
DOSAGE - CAPSULE;ORAL - 0.8-100mCi
USFDA APPLICATION NUMBER - 16517
DOSAGE - CAPSULE;ORAL - 0.009-0.1mCi
USFDA APPLICATION NUMBER - 21305
DOSAGE - SOLUTION;ORAL - 250-1000mCi
USFDA APPLICATION NUMBER - 21305
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ABOUT THIS PAGE
A Sodium Iodide-131 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Iodide-131, including repackagers and relabelers. The FDA regulates Sodium Iodide-131 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Iodide-131 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 Sodium Iodide-131 supplier is an individual or a company that provides Sodium Iodide-131 active pharmaceutical ingredient (API) or Sodium Iodide-131 finished formulations upon request. The Sodium Iodide-131 suppliers may include Sodium Iodide-131 API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Iodide-131 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Iodide-131 DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Iodide-131 active pharmaceutical ingredient (API) in detail. Different forms of Sodium Iodide-131 DMFs exist exist since differing nations have different regulations, such as Sodium Iodide-131 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Iodide-131 DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Iodide-131 USDMF includes data on Sodium Iodide-131's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Iodide-131 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Iodide-131 suppliers with USDMF on PharmaCompass.
Sodium Iodide-131 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 Sodium Iodide-131 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 Sodium Iodide-131 GMP manufacturer or Sodium Iodide-131 GMP API supplier for your needs.
A Sodium Iodide-131 CoA (Certificate of Analysis) is a formal document that attests to Sodium Iodide-131's compliance with Sodium Iodide-131 specifications and serves as a tool for batch-level quality control.
Sodium Iodide-131 CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Iodide-131 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.
Sodium Iodide-131 may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Iodide-131 EP), Sodium Iodide-131 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Iodide-131 USP).
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