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Methylcobalamin API Manufacturers & Suppliers
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Mecobalamin | CAS No: 13422-55-4 | GMP-certified suppliers
A medication that supports correction of vitamin B12 deficiency and helps manage peripheral neuropathies to restore hematologic balance and improve related neurologic symptoms.
Therapeutic categories
Product Snapshot
- Mecobalamin is supplied as oral solid forms and multiple intravenous or intramuscular injectable solutions
- It is sourced primarily for vitamin B12 supplementation applications, including use in deficiency-related and neurologic support indications
- It has approved and investigational status across the US and Canada markets
Clinical Overview
Its pharmacological activity relates to its role as a cofactor for methionine synthase, a key enzyme in the remethylation of homocysteine to methionine. Through supporting methionine and S‑adenosylmethionine generation, mecobalamin contributes to methylation reactions involved in myelin maintenance and neuronal function. Restoration of B12-dependent pathways can improve impaired nerve conduction associated with deficiency.
Absorption occurs primarily in the ileum via intrinsic factor–mediated uptake, with additional passive absorption at higher doses. Mecobalamin circulates bound to transcobalamin II, enabling cellular delivery. Distribution favors hepatic storage, with a physiological reserve that influences dosing frequency. Metabolism aligns with endogenous B12 utilization pathways, and excess quantities are excreted slowly in urine. Bioavailability varies with route of administration, with parenteral delivery used when malabsorption is present.
Safety data indicate that mecobalamin is generally well tolerated. Reported adverse effects include mild gastrointestinal symptoms, injection-site reactions, and rare hypersensitivity responses. High-dose exposure is typically limited by renal clearance, and no significant toxicity has been associated with therapeutic use in deficiency correction. It is approved in multiple regions and used in both prescription and investigational contexts, including as a component of vitamin B complex and antianemic formulations. Branded preparations are common in East Asian markets for neuropathic conditions and hematinic therapy.
For API procurement, suppliers should provide evidence of cobalamin identity, stereochemical integrity, and control of cobalt-related impurities. Consistent assay, stability, and light protection requirements are critical due to the photosensitivity of cobalamin derivatives, and GMP-compliant manufacturing is essential for regulatory acceptance.
Identification & chemistry
| Generic name | Mecobalamin |
|---|---|
| Molecule type | Small molecule |
| CAS | 13422-55-4 |
| UNII | BR1SN1JS2W |
| DrugBank ID | DB03614 |
Pharmacology
Targets
| Target | Organism | Actions |
|---|---|---|
| Methionine synthase | Humans | cofactor |
Formulation & handling
- Mecobalamin is a highly water‑soluble cobalamin derivative used in both oral and injectable formulations, with poor lipophilicity (LogP −14) favoring aqueous systems.
- Oral products typically require protection from moisture and light due to cobalamin photo‑ and pH‑sensitivity, though the molecule is generally stable in solid dosage forms.
- Injectable solutions (IM/IV) are formulated in aqueous media and require light protection and controlled pH to maintain cobalt‑corrin ring integrity.
Regulatory status
| Lifecycle | Patent protection for the API in the US and Canada has lapsed or is nearing expiry, placing these markets in a mature stage of the product lifecycle. As a result, competition is stable and the therapeutic role of the API is well‑established in both countries. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Mecobalamin is an established vitamin B12 active ingredient with no single originator, and manufacturing is distributed across multiple producers supplying finished products and dietary supplements. Branded products are widely available in the US and Canada, indicating broad market penetration rather than originator‑driven exclusivity. Patent protections have long expired, so generic and multi‑source competition is already well established. |
|---|
Methylcobalamin is a type of Vitamins
Vitamins are an essential subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a crucial role in maintaining optimal health and well-being. These organic compounds are required in small quantities by the human body to support various metabolic processes and ensure proper functioning of bodily systems. Vitamins can be broadly classified into two groups: fat-soluble vitamins (such as vitamins A, D, E, and K) and water-soluble vitamins (including vitamin C and B-complex vitamins). Each vitamin has a specific role and function within the body.
Pharmaceutical APIs in the vitamin subcategory are carefully synthesized or extracted to meet stringent quality standards and ensure purity, efficacy, and safety. They are used as active ingredients in the formulation of various pharmaceutical products, including dietary supplements, fortified foods, and pharmaceutical formulations.
Vitamin APIs are commonly utilized in the pharmaceutical industry for their therapeutic benefits. For instance, vitamin D API is widely prescribed to treat deficiencies and maintain optimal bone health, while vitamin C API is utilized for its antioxidant properties and immune-boosting effects. B-complex vitamins, such as vitamin B12 API, are essential for energy production and nerve function.
Overall, vitamins are integral to maintaining good health, and pharmaceutical APIs in this subcategory play a vital role in providing these essential nutrients to individuals through various pharmaceutical and dietary applications.
Methylcobalamin (Vitamins), classified under Therapeutic Nutrients/Minerals/Electrolyte
Therapeutic Nutrients/Minerals/Electrolytes: A Comprehensive Technical DescriptionTherapeutic nutrients, minerals, and electrolytes are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to support and enhance overall health and well-being. These compounds play a crucial role in maintaining the body's physiological balance, aiding in various metabolic processes, and addressing specific deficiencies.
Therapeutic nutrients encompass a broad range of substances, including vitamins, minerals, and electrolytes. Vitamins are organic compounds required in small quantities for proper bodily functions and are essential for growth, development, and disease prevention. Minerals, on the other hand, are inorganic substances that support numerous physiological processes, such as bone formation, nerve function, and energy production.
Electrolytes are minerals that carry an electric charge when dissolved in bodily fluids, including sodium, potassium, calcium, magnesium, and chloride. They play a crucial role in maintaining proper hydration, nerve impulses, muscle contractions, and pH balance.
Pharmaceutical APIs in the Therapeutic Nutrients/Minerals/Electrolyte category are designed to address specific deficiencies or imbalances in the body. These APIs are often used in the formulation of dietary supplements, nutritional products, and therapeutic treatments. They are manufactured under stringent quality control guidelines to ensure purity, potency, and bioavailability.
Therapeutic nutrients/minerals/electrolytes APIs are available in various forms, including tablets, capsules, powders, and liquid formulations. They are formulated to meet specific dosage requirements and can be combined with other ingredients for targeted health benefits.
Overall, therapeutic nutrients, minerals, and electrolytes APIs are essential components in maintaining optimal health. Their use helps address deficiencies, support bodily functions, and promote overall well-being. Pharmaceutical companies and healthcare professionals rely on these high-quality APIs to develop effective and safe products that contribute to a healthier population.
Methylcobalamin API manufacturers & distributors
Compare qualified Methylcobalamin API suppliers worldwide. We currently have 11 companies offering Methylcobalamin API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 250 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, MSDS, USDMF | 235 products |
| Chemizo Enterprise | Distributor | India | India | CoA | 19 products |
| Chr. Olesen Group | Distributor | Denmark | China | CoA, GMP, MSDS, USDMF | 252 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hebei Huarong | Producer | China | China | CoA, JDMF, USDMF | 4 products |
| Ningxia Kingvit | Producer | China | China | CEP, CoA, GMP, Other, Other, WC | 2 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS | 762 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Vital Laboratories Pvt. L... | Producer | India | India | CoA, USDMF, WC | 22 products |
When sending a request, specify which Methylcobalamin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Methylcobalamin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Methylcobalamin API
Sourcing
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Technical
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Regulatory
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Pharmaoffer
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