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DOSAGE - SOLUTION;ORAL, RECTAL - 66%;10%
USFDA APPLICATION NUMBER - 11245
DOSAGE - INJECTABLE;INJECTION - 66%;10%
USFDA APPLICATION NUMBER - 19292
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ABOUT THIS PAGE
A Meglumine sodium amidotrizoate injection manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Meglumine sodium amidotrizoate injection, including repackagers and relabelers. The FDA regulates Meglumine sodium amidotrizoate injection manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Meglumine sodium amidotrizoate injection 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 Meglumine sodium amidotrizoate injection manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Meglumine sodium amidotrizoate injection supplier is an individual or a company that provides Meglumine sodium amidotrizoate injection active pharmaceutical ingredient (API) or Meglumine sodium amidotrizoate injection finished formulations upon request. The Meglumine sodium amidotrizoate injection suppliers may include Meglumine sodium amidotrizoate injection API manufacturers, exporters, distributors and traders.
click here to find a list of Meglumine sodium amidotrizoate injection suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Meglumine sodium amidotrizoate injection DMF (Drug Master File) is a document detailing the whole manufacturing process of Meglumine sodium amidotrizoate injection active pharmaceutical ingredient (API) in detail. Different forms of Meglumine sodium amidotrizoate injection DMFs exist exist since differing nations have different regulations, such as Meglumine sodium amidotrizoate injection USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Meglumine sodium amidotrizoate injection DMF submitted to regulatory agencies in the US is known as a USDMF. Meglumine sodium amidotrizoate injection USDMF includes data on Meglumine sodium amidotrizoate injection's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Meglumine sodium amidotrizoate injection USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A Meglumine sodium amidotrizoate injection written confirmation (Meglumine sodium amidotrizoate injection WC) is an official document issued by a regulatory agency to a Meglumine sodium amidotrizoate injection manufacturer, verifying that the manufacturing facility of a Meglumine sodium amidotrizoate injection active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Meglumine sodium amidotrizoate injection APIs or Meglumine sodium amidotrizoate injection finished pharmaceutical products to another nation, regulatory agencies frequently require a Meglumine sodium amidotrizoate injection WC (written confirmation) as part of the regulatory process.
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Meglumine sodium amidotrizoate injection as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Meglumine sodium amidotrizoate injection API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Meglumine sodium amidotrizoate injection as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Meglumine sodium amidotrizoate injection and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Meglumine sodium amidotrizoate injection NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Meglumine sodium amidotrizoate injection suppliers with NDC on PharmaCompass.
Meglumine sodium amidotrizoate injection 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 Meglumine sodium amidotrizoate injection 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 Meglumine sodium amidotrizoate injection GMP manufacturer or Meglumine sodium amidotrizoate injection GMP API supplier for your needs.
A Meglumine sodium amidotrizoate injection CoA (Certificate of Analysis) is a formal document that attests to Meglumine sodium amidotrizoate injection's compliance with Meglumine sodium amidotrizoate injection specifications and serves as a tool for batch-level quality control.
Meglumine sodium amidotrizoate injection CoA mostly includes findings from lab analyses of a specific batch. For each Meglumine sodium amidotrizoate injection 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.
Meglumine sodium amidotrizoate injection may be tested according to a variety of international standards, such as European Pharmacopoeia (Meglumine sodium amidotrizoate injection EP), Meglumine sodium amidotrizoate injection JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Meglumine sodium amidotrizoate injection USP).
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