Methylcobalamin
CAS No.: 13422-55-4
Synonym: Mecobalamin, Mecobalaminum,
Mol. Formula: C₆₃H₉₁CoN₁₃O₁₄P
Mol. Weight: 1,344.4 g/mol
ATC Code: B03BA05
Therapeutic Category: Antianemic agent
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality:
Methylcobalamin API, an active form of Vitamin B12 used in neurological therapies, dietary supplements, and energy metabolism support, is manufactured under strict GMP and ISO 9001:2015 standards. Each batch undergoes rigorous analytical testing for purity, potency, and impurity profiling to ensure compliance with global pharmacopeial standards, delivering consistent quality and therapeutic efficacy.

2) Comprehensive Documentation:
Amber Lifesciences provides complete regulatory documentation for Methylcobalamin API, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), stability reports, and CTD/ACTD dossiers. This thorough documentation ensures regulatory compliance and smooth product registration in global markets.

3) Secure Supply Chain:
Amber Lifesciences maintains a robust and traceable supply chain to guarantee uninterrupted availability of Methylcobalamin API. Temperature-controlled storage, validated packaging, and continuous quality monitoring safeguard product integrity throughout production, storage, and worldwide distribution.

4) Manufacturer & Supplier Expertise:
With extensive experience in vitamin and nutrient synthesis, process optimization, and analytical validation, Amber Lifesciences ensures reproducible, large-scale production of Methylcobalamin API. Their R&D and quality assurance teams uphold stringent international regulatory standards, delivering consistent, high-quality APIs.

5) Amber Lifesciences’ Role:
Amber Lifesciences Pvt. Ltd. is a trusted global manufacturer and supplier of Methylcobalamin API. Their focus on superior quality, comprehensive documentation, and secure supply chain solutions positions them as a preferred partner for pharmaceutical and nutraceutical companies worldwide seeking GMP-certified, high-quality vitamin B12 APIs.

Active Pharmaceutical Ingredient (API) – Not for Direct Human or Veterinary Use.