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1. Magnesium Pantoprazole
2. Pantoprazole Hemimagnesium
3. 1022083-88-0
4. 1al13b11r4
5. 199387-73-0
6. Unii-1al13b11r4
7. Pantoprazolemagnesium
8. Amy22223
9. Pantoprazole Magnesium [who-dd]
10. Q27252161
| Molecular Weight | 789.0 g/mol |
|---|---|
| Molecular Formula | C32H28F4MgN6O8S2 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 20 |
| Rotatable Bond Count | 14 |
| Exact Mass | 788.1196586 g/mol |
| Monoisotopic Mass | 788.1196586 g/mol |
| Topological Polar Surface Area | 182 Ų |
| Heavy Atom Count | 53 |
| Formal Charge | 0 |
| Complexity | 490 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 2 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
API SUPPLIERS
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USDMF
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Patents & EXCLUSIVITIES
ABOUT THIS PAGE
A Pantoprazole Magnesium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pantoprazole Magnesium, including repackagers and relabelers. The FDA regulates Pantoprazole Magnesium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pantoprazole Magnesium 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 Pantoprazole Magnesium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pantoprazole Magnesium supplier is an individual or a company that provides Pantoprazole Magnesium active pharmaceutical ingredient (API) or Pantoprazole Magnesium finished formulations upon request. The Pantoprazole Magnesium suppliers may include Pantoprazole Magnesium API manufacturers, exporters, distributors and traders.
click here to find a list of Pantoprazole Magnesium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pantoprazole Magnesium DMF (Drug Master File) is a document detailing the whole manufacturing process of Pantoprazole Magnesium active pharmaceutical ingredient (API) in detail. Different forms of Pantoprazole Magnesium DMFs exist exist since differing nations have different regulations, such as Pantoprazole Magnesium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pantoprazole Magnesium DMF submitted to regulatory agencies in the US is known as a USDMF. Pantoprazole Magnesium USDMF includes data on Pantoprazole Magnesium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pantoprazole Magnesium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pantoprazole Magnesium suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Pantoprazole Magnesium Drug Master File in Korea (Pantoprazole Magnesium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pantoprazole Magnesium. The MFDS reviews the Pantoprazole Magnesium KDMF as part of the drug registration process and uses the information provided in the Pantoprazole Magnesium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pantoprazole Magnesium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Pantoprazole Magnesium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pantoprazole Magnesium suppliers with KDMF on PharmaCompass.
A Pantoprazole Magnesium written confirmation (Pantoprazole Magnesium WC) is an official document issued by a regulatory agency to a Pantoprazole Magnesium manufacturer, verifying that the manufacturing facility of a Pantoprazole Magnesium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pantoprazole Magnesium APIs or Pantoprazole Magnesium finished pharmaceutical products to another nation, regulatory agencies frequently require a Pantoprazole Magnesium WC (written confirmation) as part of the regulatory process.
click here to find a list of Pantoprazole Magnesium 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 Pantoprazole Magnesium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pantoprazole Magnesium 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 Pantoprazole Magnesium 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 Pantoprazole Magnesium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pantoprazole Magnesium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pantoprazole Magnesium suppliers with NDC on PharmaCompass.
Pantoprazole Magnesium 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 Pantoprazole Magnesium 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 Pantoprazole Magnesium GMP manufacturer or Pantoprazole Magnesium GMP API supplier for your needs.
A Pantoprazole Magnesium CoA (Certificate of Analysis) is a formal document that attests to Pantoprazole Magnesium's compliance with Pantoprazole Magnesium specifications and serves as a tool for batch-level quality control.
Pantoprazole Magnesium CoA mostly includes findings from lab analyses of a specific batch. For each Pantoprazole Magnesium 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.
Pantoprazole Magnesium may be tested according to a variety of international standards, such as European Pharmacopoeia (Pantoprazole Magnesium EP), Pantoprazole Magnesium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pantoprazole Magnesium USP).
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