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1. Ch3-b12
2. Mecobalamin
3. Mecobalamin Monohydrate
4. Mecobalamin, (13beta)-isomer
5. Mecobalamin, 3h-labeled
6. Mecobalamin, 57co-labeled
7. Mecobalamin, Co-methyl-13c-labeled
8. Mecobalamin, Co-methyl-14c-labeled
9. Methylcobalamin
10. Methylcobalamine
11. Methylvitamin B12
1. Methylcobalamin
2. 13422-55-4
| Molecular Weight | 1344.4 g/mol |
|---|---|
| Molecular Formula | C63H91CoN13O14P |
| Hydrogen Bond Donor Count | 9 |
| Hydrogen Bond Acceptor Count | 20 |
| Rotatable Bond Count | 26 |
| Exact Mass | 1343.587800 g/mol |
| Monoisotopic Mass | 1343.587800 g/mol |
| Topological Polar Surface Area | 452 Ų |
| Heavy Atom Count | 92 |
| Formal Charge | 0 |
| Complexity | 3140 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 14 |
| Defined Bond Stereocenter Count | 3 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
API SUPPLIERS
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USDMF
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Average Price (USD/KGS) |
Number of Transactions |
|---|
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ABOUT THIS PAGE
A Methylcobalamin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylcobalamin, including repackagers and relabelers. The FDA regulates Methylcobalamin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylcobalamin 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 Methylcobalamin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methylcobalamin supplier is an individual or a company that provides Methylcobalamin active pharmaceutical ingredient (API) or Methylcobalamin finished formulations upon request. The Methylcobalamin suppliers may include Methylcobalamin API manufacturers, exporters, distributors and traders.
click here to find a list of Methylcobalamin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methylcobalamin DMF (Drug Master File) is a document detailing the whole manufacturing process of Methylcobalamin active pharmaceutical ingredient (API) in detail. Different forms of Methylcobalamin DMFs exist exist since differing nations have different regulations, such as Methylcobalamin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methylcobalamin DMF submitted to regulatory agencies in the US is known as a USDMF. Methylcobalamin USDMF includes data on Methylcobalamin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methylcobalamin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methylcobalamin suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Methylcobalamin Drug Master File in Japan (Methylcobalamin JDMF) empowers Methylcobalamin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Methylcobalamin JDMF during the approval evaluation for pharmaceutical products. At the time of Methylcobalamin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Methylcobalamin suppliers with JDMF 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 Methylcobalamin Drug Master File in Korea (Methylcobalamin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Methylcobalamin. The MFDS reviews the Methylcobalamin KDMF as part of the drug registration process and uses the information provided in the Methylcobalamin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Methylcobalamin 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 Methylcobalamin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Methylcobalamin suppliers with KDMF on PharmaCompass.
A Methylcobalamin written confirmation (Methylcobalamin WC) is an official document issued by a regulatory agency to a Methylcobalamin manufacturer, verifying that the manufacturing facility of a Methylcobalamin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Methylcobalamin APIs or Methylcobalamin finished pharmaceutical products to another nation, regulatory agencies frequently require a Methylcobalamin WC (written confirmation) as part of the regulatory process.
click here to find a list of Methylcobalamin 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 Methylcobalamin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Methylcobalamin 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 Methylcobalamin 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 Methylcobalamin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methylcobalamin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Methylcobalamin suppliers with NDC on PharmaCompass.
Methylcobalamin 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 Methylcobalamin 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 Methylcobalamin GMP manufacturer or Methylcobalamin GMP API supplier for your needs.
A Methylcobalamin CoA (Certificate of Analysis) is a formal document that attests to Methylcobalamin's compliance with Methylcobalamin specifications and serves as a tool for batch-level quality control.
Methylcobalamin CoA mostly includes findings from lab analyses of a specific batch. For each Methylcobalamin 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.
Methylcobalamin may be tested according to a variety of international standards, such as European Pharmacopoeia (Methylcobalamin EP), Methylcobalamin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methylcobalamin USP).
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