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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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HealthTech BioActives, leading globally in Flavonoids and Vitamin B12 Derivatives.
NDC Package Code : 84069-001
Start Marketing Date : 2024-02-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
NDC Package Code : 61281-9500
Start Marketing Date : 2013-09-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
NDC Package Code : 61281-9000
Start Marketing Date : 2013-09-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71052-047
Start Marketing Date : 2017-05-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51552-1609
Start Marketing Date : 2021-06-17
End Marketing Date : 2026-02-28
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 51927-0220
Start Marketing Date : 2021-12-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 10695-174
Start Marketing Date : 2023-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 85207-007
Start Marketing Date : 2025-06-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
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NDC Package Code : 85617-002
Start Marketing Date : 2025-04-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
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NDC Package Code : 84583-003
Start Marketing Date : 2023-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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PharmaCompass offers a list of Methylcobalamin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Methylcobalamin manufacturer or Methylcobalamin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methylcobalamin manufacturer or Methylcobalamin supplier.
PharmaCompass also assists you with knowing the Methylcobalamin API Price utilized in the formulation of products. Methylcobalamin API Price is not always fixed or binding as the Methylcobalamin Price is obtained through a variety of data sources. The Methylcobalamin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mecobalamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mecobalamine, including repackagers and relabelers. The FDA regulates Mecobalamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mecobalamine 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 Mecobalamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mecobalamine supplier is an individual or a company that provides Mecobalamine active pharmaceutical ingredient (API) or Mecobalamine finished formulations upon request. The Mecobalamine suppliers may include Mecobalamine API manufacturers, exporters, distributors and traders.
click here to find a list of Mecobalamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mecobalamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Mecobalamine active pharmaceutical ingredient (API) in detail. Different forms of Mecobalamine DMFs exist exist since differing nations have different regulations, such as Mecobalamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mecobalamine DMF submitted to regulatory agencies in the US is known as a USDMF. Mecobalamine USDMF includes data on Mecobalamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mecobalamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mecobalamine 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 Mecobalamine Drug Master File in Japan (Mecobalamine JDMF) empowers Mecobalamine 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 Mecobalamine JDMF during the approval evaluation for pharmaceutical products. At the time of Mecobalamine 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 Mecobalamine 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 Mecobalamine Drug Master File in Korea (Mecobalamine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mecobalamine. The MFDS reviews the Mecobalamine KDMF as part of the drug registration process and uses the information provided in the Mecobalamine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mecobalamine 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 Mecobalamine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mecobalamine suppliers with KDMF on PharmaCompass.
A Mecobalamine written confirmation (Mecobalamine WC) is an official document issued by a regulatory agency to a Mecobalamine manufacturer, verifying that the manufacturing facility of a Mecobalamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mecobalamine APIs or Mecobalamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Mecobalamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Mecobalamine 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 Mecobalamine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mecobalamine 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 Mecobalamine 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 Mecobalamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mecobalamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mecobalamine suppliers with NDC on PharmaCompass.
Mecobalamine 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 Mecobalamine 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 Mecobalamine GMP manufacturer or Mecobalamine GMP API supplier for your needs.
A Mecobalamine CoA (Certificate of Analysis) is a formal document that attests to Mecobalamine's compliance with Mecobalamine specifications and serves as a tool for batch-level quality control.
Mecobalamine CoA mostly includes findings from lab analyses of a specific batch. For each Mecobalamine 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.
Mecobalamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Mecobalamine EP), Mecobalamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mecobalamine USP).
