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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 |
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
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Details:
Methycobal (methylcobalamin) is the active form of vitamin B12. It is indicated for the treatment of peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency.
Lead Product(s): Methylcobalamin
Therapeutic Area: Neurology Brand Name: E0302
Study Phase: Phase IIIProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 26, 2024
Lead Product(s) : Methylcobalamin
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Eisai Submits NDA in Japan for Ultrahigh-Dose Mecobalamin to Treat ALS
Details : Methycobal (methylcobalamin) is the active form of vitamin B12. It is indicated for the treatment of peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency.
Product Name : E0302
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
January 26, 2024
Details:
An analysis of Study 761 suggested that ultrahigh-dose E0302 (methylcobalamin) prolonged survival period and suppressed progression in ALS patients who commenced treatment within 12 months of ALS onset.
Lead Product(s): Methylcobalamin
Therapeutic Area: Neurology Brand Name: E0302
Study Phase: Phase IIIProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 05, 2022
Lead Product(s) : Methylcobalamin
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : An analysis of Study 761 suggested that ultrahigh-dose E0302 (methylcobalamin) prolonged survival period and suppressed progression in ALS patients who commenced treatment within 12 months of ALS onset.
Product Name : E0302
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
October 05, 2022
Details:
Mecobalamin (generic name, development code: E0302) is approved and marketed as Methycobal®, a 500 µg injection of mecobalamin indicated for the treatment of peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency.
Lead Product(s): Methylcobalamin
Therapeutic Area: Neurology Brand Name: E0302
Study Phase: Phase IIIProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 27, 2022
Lead Product(s) : Methylcobalamin
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Mecobalamin (generic name, development code: E0302) is approved and marketed as Methycobal®, a 500 µg injection of mecobalamin indicated for the treatment of peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency.
Product Name : E0302
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
May 27, 2022
Regulatory Info :
Registration Country : Turkey
Brand Name : Pagamax Plus
Dosage Form :
Dosage Strength : 75MG; 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Regulatory Info :
Registration Country : Turkey
Brand Name : Pagamax Plus
Dosage Form :
Dosage Strength : 150MG; 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Regulatory Info :
Registration Country : Turkey
Brand Name : Pagamax Plus
Dosage Form :
Dosage Strength : 300MG; 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Regulatory Info : Generic
Registration Country : Turkey
Diclofenac Sodium; Thiamine; Pyridoxine; Cobamet
Brand Name :
Dosage Form : CAPSULE
Dosage Strength : 50MG; 50MG; 50MG; 0.25MG
Packaging : 20 Capsules
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 500MCG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 500MCG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name : Renerve 250
Dosage Form : TABLET
Dosage Strength : 250MCG
Packaging : 10x1x10 Alu-Alu
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Packaging : 10x1x10 Alu-Alu
Regulatory Info : Generic
Dosage : TABLET
Dosage Strength : 250MCG
Brand Name : Renerve 250
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Commercialized In: India (2008...
Registration Country : India
Brand Name :
Dosage Form : Sustained Release Tabl...
Dosage Strength : 150MG; 1500MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Commercialized In: India (2008...
Registration Country : India
Packaging :
Regulatory Info : Commercialized In: India (2008...
Dosage : Sustained Release Tabl...
Dosage Strength : 150MG; 1500MCG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Benfotiamine; Methylcobalamin; alpha-Lipoic Acid; Inositol; Folic Acid; Pyridoxine Hydrochloride
Brand Name :
Dosage Form : Softgelatin Capsule
Dosage Strength : 100MG; 1000MCG; 200MCG...
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Benfotiamine; Methylcobalamin; alpha-Lipoic Acid; Inositol; Folic Acid; Pyridoxine Hydrochloride
Dosage : Softgelatin Capsule
Dosage Strength : 100MG; 1000MCG; 200MCG...
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Pyridoxal Phosphate; Methylcobalamin
Brand Name :
Dosage Form : Softgelatin Capsule
Dosage Strength : 500MCG; 1500MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Pyridoxal Phosphate; Methylcobalamin
Dosage : Softgelatin Capsule
Dosage Strength : 500MCG; 1500MCG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : Menerve
Dosage Form : Capsule
Dosage Strength : 750MCG; 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 750MCG; 75MG
Brand Name : Menerve
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : Mepex
Dosage Form : Capsule
Dosage Strength : 750MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 750MG
Brand Name : Mepex
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : NUROVITA P
Dosage Form : Capsule
Dosage Strength : 75MG; 750MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 75MG; 750MCG
Brand Name : NUROVITA P
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Ferrous Ascorbate; Folic Acid; Vitamin B6; Zinc; Mecobalamin; AMINO ACIDS
Brand Name : Nicefer
Dosage Form : Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Ferrous Ascorbate; Folic Acid; Vitamin B6; Zinc; Mecobalamin; AMINO ACIDS
Dosage : Tablet
Dosage Strength :
Brand Name : Nicefer
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
methylcobalamin; Folic Acid; Pyridoxine Hydrochloride; Thioctic Acid; Thiamine Hydrochloride
Brand Name :
Dosage Form : Capsule
Dosage Strength : 500MCG; 1.5MG; 3MG; 10...
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
methylcobalamin; Folic Acid; Pyridoxine Hydrochloride; Thioctic Acid; Thiamine Hydrochloride
Dosage : Capsule
Dosage Strength : 500MCG; 1.5MG; 3MG; 10...
Brand Name :
Approval Date :
Application Number :
Registration Country : India
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
34
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 Methycobal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methycobal, including repackagers and relabelers. The FDA regulates Methycobal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methycobal 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 Methycobal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methycobal supplier is an individual or a company that provides Methycobal active pharmaceutical ingredient (API) or Methycobal finished formulations upon request. The Methycobal suppliers may include Methycobal API manufacturers, exporters, distributors and traders.
click here to find a list of Methycobal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methycobal DMF (Drug Master File) is a document detailing the whole manufacturing process of Methycobal active pharmaceutical ingredient (API) in detail. Different forms of Methycobal DMFs exist exist since differing nations have different regulations, such as Methycobal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methycobal DMF submitted to regulatory agencies in the US is known as a USDMF. Methycobal USDMF includes data on Methycobal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methycobal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methycobal 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 Methycobal Drug Master File in Japan (Methycobal JDMF) empowers Methycobal 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 Methycobal JDMF during the approval evaluation for pharmaceutical products. At the time of Methycobal 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 Methycobal 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 Methycobal Drug Master File in Korea (Methycobal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Methycobal. The MFDS reviews the Methycobal KDMF as part of the drug registration process and uses the information provided in the Methycobal KDMF to evaluate the safety and efficacy of the drug.
After submitting a Methycobal 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 Methycobal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Methycobal suppliers with KDMF on PharmaCompass.
A Methycobal written confirmation (Methycobal WC) is an official document issued by a regulatory agency to a Methycobal manufacturer, verifying that the manufacturing facility of a Methycobal active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Methycobal APIs or Methycobal finished pharmaceutical products to another nation, regulatory agencies frequently require a Methycobal WC (written confirmation) as part of the regulatory process.
click here to find a list of Methycobal 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 Methycobal as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Methycobal 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 Methycobal 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 Methycobal and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methycobal NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Methycobal suppliers with NDC on PharmaCompass.
Methycobal 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 Methycobal 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 Methycobal GMP manufacturer or Methycobal GMP API supplier for your needs.
A Methycobal CoA (Certificate of Analysis) is a formal document that attests to Methycobal's compliance with Methycobal specifications and serves as a tool for batch-level quality control.
Methycobal CoA mostly includes findings from lab analyses of a specific batch. For each Methycobal 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.
Methycobal may be tested according to a variety of international standards, such as European Pharmacopoeia (Methycobal EP), Methycobal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methycobal USP).