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Chemistry

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Also known as: Methylcobalamin, 13422-55-4
Molecular Formula
C63H91CoN13O14P
Molecular Weight
1344.4  g/mol
InChI Key
ZFLASALABLFSNM-UHFFFAOYSA-L

Methylcobalamin
1 2D Structure

Methylcobalamin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
carbanide;cobalt(3+);[5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] 1-[3-[(4Z,9Z,14Z)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2,7,12,17-tetrahydro-1H-corrin-21-id-3-yl]propanoylamino]propan-2-yl phosphate
2.1.2 InChI
InChI=1S/C62H90N13O14P.CH3.Co/c1-29-20-39-40(21-30(29)2)75(28-70-39)57-52(84)53(41(27-76)87-57)89-90(85,86)88-31(3)26-69-49(83)18-19-59(8)37(22-46(66)80)56-62(11)61(10,25-48(68)82)36(14-17-45(65)79)51(74-62)33(5)55-60(9,24-47(67)81)34(12-15-43(63)77)38(71-55)23-42-58(6,7)35(13-16-44(64)78)50(72-42)32(4)54(59)73-56;;/h20-21,23,28,31,34-37,41,52-53,56-57,76,84H,12-19,22,24-27H2,1-11H3,(H15,63,64,65,66,67,68,69,71,72,73,74,77,78,79,80,81,82,83,85,86);1H3;/q;-1;+3/p-2
2.1.3 InChI Key
ZFLASALABLFSNM-UHFFFAOYSA-L
2.1.4 Canonical SMILES
[CH3-].CC1=CC2=C(C=C1C)N(C=N2)C3C(C(C(O3)CO)OP(=O)([O-])OC(C)CNC(=O)CCC4(C(C5C6(C(C(C(=N6)C(=C7C(C(C(=N7)C=C8C(C(C(=N8)C(=C4[N-]5)C)CCC(=O)N)(C)C)CCC(=O)N)(C)CC(=O)N)C)CCC(=O)N)(C)CC(=O)N)C)CC(=O)N)C)O.[Co+3]
2.1.5 Isomeric SMILES
[CH3-].CC1=CC2=C(C=C1C)N(C=N2)C3C(C(C(O3)CO)OP(=O)([O-])OC(C)CNC(=O)CCC\4(C(C5C6(C(C(C(=N6)/C(=C\7/C(C(C(=N7)/C=C\8/C(C(C(=N8)/C(=C4\[N-]5)/C)CCC(=O)N)(C)C)CCC(=O)N)(C)CC(=O)N)/C)CCC(=O)N)(C)CC(=O)N)C)CC(=O)N)C)O.[Co+3]
2.2 Synonyms
2.2.1 MeSH Synonyms

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

2.2.2 Depositor-Supplied Synonyms

1. Methylcobalamin

2. 13422-55-4

2.3 Create Date
2006-04-28
3 Chemical and Physical Properties
Molecular Weight 1344.4 g/mol
Molecular Formula C63H91CoN13O14P
Hydrogen Bond Donor Count9
Hydrogen Bond Acceptor Count20
Rotatable Bond Count26
Exact Mass1343.587800 g/mol
Monoisotopic Mass1343.587800 g/mol
Topological Polar Surface Area452 Ų
Heavy Atom Count92
Formal Charge0
Complexity3140
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count14
Defined Bond Stereocenter Count3
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3

API Reference Price

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02-Jan-2021
28-Feb-2025
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Drugs in Development

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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

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01

Eisai

Japan
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Drug Discovery Chemistry
Not Confirmed

Eisai

Japan
arrow
Drug Discovery Chemistry
Not Confirmed

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

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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

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02

Eisai

Japan
arrow
Drug Discovery Chemistry
Not Confirmed

Eisai

Japan
arrow
Drug Discovery Chemistry
Not Confirmed

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

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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

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03

Eisai

Japan
arrow
Drug Discovery Chemistry
Not Confirmed

Eisai

Japan
arrow
Drug Discovery Chemistry
Not Confirmed

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

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Europe

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Drug Discovery Chemistry
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Drug Discovery Chemistry
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Pregabalin; Cobamet

Brand Name : Pagamax Plus

Dosage Form :

Dosage Strength : 75MG; 1MG

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Brand Name : Pagamax Plus

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Diclofenac Sodium; Thiamine; Pyridoxine; Cobamet

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Dosage Strength : 50MG; 50MG; 50MG; 0.25MG

Packaging : 20 Capsules

Approval Date :

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Regulatory Info : Generic

Registration Country : Turkey

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Methylcobalamin

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Cobamet

Brand Name : Renerve 250

Dosage Form : TABLET

Dosage Strength : 250MCG

Packaging : 10x1x10 Alu-Alu

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Cobamet

Dosage : TABLET

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Brand Name : Renerve 250

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Registration Country : India

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Pregabalin; Cobamet

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Dosage Strength : 150MG; 1500MCG

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Benfotiamine; Methylcobalamin; alpha-Lipoic Acid; Inositol; Folic Acid; Pyridoxine Hydrochloride

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Dosage : Softgelatin Capsule

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Pyridoxal Phosphate; Methylcobalamin

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Cobamet; Pregabalin

Brand Name : Menerve

Dosage Form : Capsule

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Dosage : Capsule

Dosage Strength : 750MCG; 75MG

Brand Name : Menerve

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Registration Country : India

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Cobamet

Brand Name : Mepex

Dosage Form : Capsule

Dosage Strength : 750MG

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Dosage : Capsule

Dosage Strength : 750MG

Brand Name : Mepex

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Registration Country : India

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Pregabalin; Cobamet

Brand Name : NUROVITA P

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Dosage : Capsule

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Brand Name : NUROVITA P

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Ferrous Ascorbate; Folic Acid; Vitamin B6; Zinc; Mecobalamin; AMINO ACIDS

Brand Name : Nicefer

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Ferrous Ascorbate; Folic Acid; Vitamin B6; Zinc; Mecobalamin; AMINO ACIDS

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Brand Name : Nicefer

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Registration Country : India

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India
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methylcobalamin; Folic Acid; Pyridoxine Hydrochloride; Thioctic Acid; Thiamine Hydrochloride

Brand Name :

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Dosage Strength : 500MCG; 1.5MG; 3MG; 10...

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Registration Country : India

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methylcobalamin; Folic Acid; Pyridoxine Hydrochloride; Thioctic Acid; Thiamine Hydrochloride

Dosage : Capsule

Dosage Strength : 500MCG; 1.5MG; 3MG; 10...

Brand Name :

Approval Date :

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Registration Country : India

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ABOUT THIS PAGE

Looking for 13422-55-4 / Methylcobalamin API manufacturers, exporters & distributors?

Methylcobalamin manufacturers, exporters & distributors 1

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.

API | Excipient name

Methylcobalamin

Synonyms

13422-55-4

Cas Number

13422-55-4

Methycobal Manufacturers

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.

Methycobal Suppliers

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.

Methycobal USDMF

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.

Methycobal JDMF

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.

Methycobal KDMF

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.

Methycobal WC

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.

Methycobal NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Methycobal API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Methycobal CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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