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Riboflavin | CAS No: 83-88-5 | GMP-certified suppliers
A medication that addresses vitamin B2 deficiency while supporting metabolic processes and maintaining healthy skin and ocular function for reliable nutritional deficiency management.
Therapeutic categories
Primary indications
- For the treatment of ariboflavinosis (vitamin B2 deficiency)
Product Snapshot
- Riboflavin is available primarily as oral solid/liquid formulations with additional injectable and topical forms for broader formulation flexibility
- It is used for correction of riboflavin (vitamin B2) deficiency
- It is approved in the US and Canada with use spanning approved, investigational, nutraceutical, and veterinary categories
Clinical Overview
Pharmacologically, riboflavin functions as an essential micronutrient involved in the metabolism of carbohydrates, fats, and proteins. It contributes to red blood cell formation, cellular respiration pathways, and normal growth processes. Consistent with its role in energy metabolism and tissue maintenance, riboflavin participates in antibody production and supports functions relevant to skin and ocular health.
The mechanism of action is based on riboflavin’s conversion to FMN and FAD. These coenzymes enable electron transfer processes and support antioxidant pathways. FAD-dependent glutathione reductase is central to the regeneration of reduced glutathione, which acts as a cofactor for selenium-containing glutathione peroxidases. Through these reactions, riboflavin indirectly contributes to cellular protection against oxidative stress.
Absorption occurs primarily in the proximal small intestine through carrier-mediated transport, which becomes saturable at higher doses. Systemic distribution reflects conversion to FMN and FAD within cells. Excess riboflavin and its metabolites are eliminated via the urine due to its water solubility. Toxicity is low, with gastrointestinal intolerance being the most common effect at high oral intakes. Clinically significant drug interactions are uncommon, although alterations in absorption may occur with certain conditions affecting intestinal transport.
Riboflavin is used globally both as a therapeutic vitamin preparation and within multivitamin products. Branded and non-branded formulations vary by region.
For API sourcing, attention should focus on compliance with pharmacopeial specifications, control of photodegradation, and verification of impurity profiles, as flavins are sensitive to light and oxidative conditions.
Identification & chemistry
| Generic name | Riboflavin |
|---|---|
| Molecule type | Small molecule |
| CAS | 83-88-5 |
| UNII | TLM2976OFR |
| DrugBank ID | DB00140 |
Pharmacology
| Summary | Riboflavin functions as a precursor to the flavin cofactors FMN and FAD, enabling redox reactions central to cellular metabolism and antioxidant pathways. It interacts with riboflavin kinase, riboflavin synthase, and related flavin-processing enzymes to support energy production and glutathione-dependent oxidative stress control. Therapeutically, it is used to correct ariboflavinosis resulting from vitamin B2 deficiency. |
|---|---|
| Mechanism of action | Binds to riboflavin hydrogenase, riboflavin kinase, and riboflavin synthase. Riboflavin is the precursor of flavin mononucleotide (FMN, riboflavin monophosphate) and flavin adenine dinucleotide (FAD). The antioxidant activity of riboflavin is principally derived from its role as a precursor of FAD and the role of this cofactor in the production of the antioxidant reduced glutathione. Reduced glutathione is the cofactor of the selenium-containing glutathione peroxidases among other things. The glutathione peroxidases are major antioxidant enzymes. Reduced glutathione is generated by the FAD-containing enzyme glutathione reductase. |
| Pharmacodynamics | Riboflavin or vitamin B2 is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolising of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity. Riboflavin also helps in the prevention or treatment of many types of eye disorders, including some cases of cataracts. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Riboflavin kinase | Humans | ligand |
| Riboflavin synthase | Escherichia coli (strain K12) | other |
| Flavin reductase (NADPH) | Humans | product of |
ADME / PK
| Absorption | Vitamin B2 is readily absorbed from the upper gastrointestinal tract. |
|---|---|
| Half-life | 66-84 minutes |
| Protein binding | 60% |
| Metabolism | Hepatic. |
Formulation & handling
- Riboflavin is a small‑molecule vitamin used mainly in oral and parenteral products, with limited aqueous solubility influencing the need for solubilizers or salt/complex approaches.
- The compound is highly light‑sensitive, requiring protection from UV/visible light during manufacturing, storage, and in final packaging, especially for solutions.
- Parenteral formulations typically use buffered, oxygen‑controlled solutions to maintain stability and limit degradation.
Regulatory status
| Lifecycle | Patent expiry in the United States and Canada will determine the API’s progression from protected to more competitive phases, with market maturity increasing as exclusivities lapse. Across these markets, lifecycle status will shift toward generic entry once remaining protections expire. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Riboflavin is a long‑established vitamin ingredient with no active originator company, and commercial supply is handled by numerous packagers and supplement manufacturers rather than a single innovator. Branded products appear broadly across North American markets, particularly in the US and Canada, mainly as components of multivitamin and nutritional formulations. Patent protection is long expired, so the landscape consists entirely of existing generic and commodity‑grade production. |
|---|
Riboflavin 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.
Riboflavin (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.
Riboflavin API manufacturers & distributors
Compare qualified Riboflavin API suppliers worldwide. We currently have 15 companies offering Riboflavin API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CoA, ISO9001, MSDS, WC | 250 products |
| BASF | Producer | Germany | Unknown | CEP, CoA, FDA, GMP | 18 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Cedarburg Pharma | Producer | United States | United States | CoA, USDMF | 12 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 235 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, USDMF | 252 products |
| Danashmand | Producer | India | India | CoA, WC | 3 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Germany | CoA, GMP, ISO9001, MSDS | 170 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Harman Finochem | Producer | India | India | CoA, GMP, WC | 34 products |
| Hubei Guangji | Producer | China | China | CEP, CoA, GMP, ISO9001 | 2 products |
| Iwaki Seiyaku | Producer | Japan | Japan | CoA, JDMF | 21 products |
| Prachi Pharmaceuticals | Producer | India | India | CoA, FDA, GMP, ISO9001, USDMF, WHO-GMP | 12 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 762 products |
When sending a request, specify which Riboflavin 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 Riboflavin 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 Riboflavin API
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Technical
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Regulatory
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