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API SUPPLIERS
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USDMF
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Thro...
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expe...
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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, RECTAL - 66%;10%
USFDA APPLICATION NUMBER - 11245
DOSAGE - SOLUTION;INTRAUTERINE - 52.7%;26.8%
USFDA APPLICATION NUMBER - 11324
DOSAGE - INJECTABLE;INJECTION - 66%;10%
USFDA APPLICATION NUMBER - 19292
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
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ABOUT THIS PAGE
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PharmaCompass offers a list of Diatrizoate Meglumine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Diatrizoate Meglumine manufacturer or Diatrizoate Meglumine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Diatrizoate Meglumine manufacturer or Diatrizoate Meglumine supplier.
A HYPAQUE-76 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of HYPAQUE-76, including repackagers and relabelers. The FDA regulates HYPAQUE-76 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. HYPAQUE-76 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 HYPAQUE-76 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A HYPAQUE-76 supplier is an individual or a company that provides HYPAQUE-76 active pharmaceutical ingredient (API) or HYPAQUE-76 finished formulations upon request. The HYPAQUE-76 suppliers may include HYPAQUE-76 API manufacturers, exporters, distributors and traders.
click here to find a list of HYPAQUE-76 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A HYPAQUE-76 DMF (Drug Master File) is a document detailing the whole manufacturing process of HYPAQUE-76 active pharmaceutical ingredient (API) in detail. Different forms of HYPAQUE-76 DMFs exist exist since differing nations have different regulations, such as HYPAQUE-76 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A HYPAQUE-76 DMF submitted to regulatory agencies in the US is known as a USDMF. HYPAQUE-76 USDMF includes data on HYPAQUE-76's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The HYPAQUE-76 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of HYPAQUE-76 suppliers with USDMF on PharmaCompass.
A HYPAQUE-76 written confirmation (HYPAQUE-76 WC) is an official document issued by a regulatory agency to a HYPAQUE-76 manufacturer, verifying that the manufacturing facility of a HYPAQUE-76 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting HYPAQUE-76 APIs or HYPAQUE-76 finished pharmaceutical products to another nation, regulatory agencies frequently require a HYPAQUE-76 WC (written confirmation) as part of the regulatory process.
click here to find a list of HYPAQUE-76 suppliers with Written Confirmation (WC) on PharmaCompass.
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 HYPAQUE-76 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for HYPAQUE-76 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 HYPAQUE-76 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 HYPAQUE-76 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a HYPAQUE-76 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of HYPAQUE-76 suppliers with NDC on PharmaCompass.
HYPAQUE-76 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 HYPAQUE-76 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right HYPAQUE-76 GMP manufacturer or HYPAQUE-76 GMP API supplier for your needs.
A HYPAQUE-76 CoA (Certificate of Analysis) is a formal document that attests to HYPAQUE-76's compliance with HYPAQUE-76 specifications and serves as a tool for batch-level quality control.
HYPAQUE-76 CoA mostly includes findings from lab analyses of a specific batch. For each HYPAQUE-76 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.
HYPAQUE-76 may be tested according to a variety of international standards, such as European Pharmacopoeia (HYPAQUE-76 EP), HYPAQUE-76 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (HYPAQUE-76 USP).
