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Folic acid | CAS No: 59-30-3 | GMP-certified suppliers
A medication that addresses folate deficiency and related megaloblastic and nutritional anemias, supporting vulnerable populations such as pregnant women, infants, children, and other at‑risk groups.
Therapeutic categories
Primary indications
- Folic acid is indicated for the treatment of folic acid deficiency, megaloblastic anemia, and in anemias of nutritional origins, pregnancy, infancy, or childhood
Product Snapshot
- Folic acid is an oral and parenteral small‑molecule vitamin available in multiple solid, liquid, and injectable formulations
- It is used for folate deficiency and related megaloblastic or nutritional anemias across various patient groups
- It is approved in the US and Canada, with use spanning human, nutraceutical, and veterinary markets
Clinical Overview
Pharmacologically, folic acid acts as a precursor to reduced folates required for one‑carbon transfer reactions. After absorption, it undergoes sequential reduction by dihydrofolate reductase to dihydrofolate and tetrahydrofolate. These active metabolites function as cofactors in the synthesis of purines, thymidylate, and methionine. Impaired folate availability compromises thymidylate formation and disrupts DNA synthesis, producing megaloblastic changes in hematopoietic tissues.
Mechanistically, tetrahydrofolate derivatives support amino acid interconversion, tRNA methylation, and formate metabolism. In the presence of vitamin B12, folate participates in remethylation of homocysteine to methionine. Cellular uptake of reduced folates occurs through receptor‑mediated processes, and folic acid itself requires metabolic activation before biological use.
Absorption occurs primarily in the proximal small intestine, with systemic distribution to tissues with high proliferative activity. Folate and its metabolites are renally excreted, and serum concentrations below approximately 5 ng/mL indicate deficiency. Drug interactions are clinically relevant; DHFR inhibitors such as methotrexate reduce the formation of active folate cofactors, and folic acid supplementation is routinely applied during low‑dose regimens. Antiepileptic agents including carbamazepine, phenytoin, and barbiturates also lower folate levels, necessitating supplementation, particularly in women of child‑bearing age.
Safety considerations include the potential for masking hematologic manifestations of vitamin B12 deficiency. High doses should be used cautiously in the context of anticonvulsant therapy due to possible effects on seizure control.
For API procurement, sourcing should prioritize compliance with pharmacopoeial specifications, verified nutrient potency, and controls on oxidative degradation to ensure stability and consistent performance in finished dosage formulations.
Identification & chemistry
| Generic name | Folic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 59-30-3 |
| UNII | 935E97BOY8 |
| DrugBank ID | DB00158 |
Pharmacology
| Summary | Folic acid is converted by dihydrofolate reductase into tetrahydrofolate derivatives that support one‑carbon transfer reactions required for purine, thymidylate, and methionine synthesis. These cofactors enable normal DNA and RNA production, amino‑acid interconversion, and erythropoiesis, particularly in rapidly dividing tissues. Cellular uptake occurs via folate receptors alpha, beta, and gamma, which facilitate endocytosis of active folate forms. |
|---|---|
| Mechanism of action | Folic acid, as it is biochemically inactive, is converted to tetrahydrofolic acid and methyltetrahydrofolate by dihydrofolate reductase (DHFR). These folic acid congeners are transported across cells by receptor-mediated endocytosis where they are needed to maintain normal erythropoiesis, synthesize purine and thymidylate nucleic acids, interconvert amino acids, methylate tRNA, and generate and use formate. Using vitamin B12 as a cofactor, folic acid can normalize high homocysteine levels by remethylation of homocysteine to methionine via methionine synthetase. |
| Pharmacodynamics | Folic acid is a water-soluble B-complex vitamin found in foods such as liver, kidney, yeast, and leafy, green vegetables. Also known as folate or Vitamin B9, folic acid is an essential cofactor for enzymes involved in DNA and RNA synthesis. More specifically, folic acid is required by the body for the synthesis of purines, pyrimidines, and methionine before incorporation into DNA or protein. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Impairment of thymidylate synthesis in patients with folic acid deficiency is thought to account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic and macrocytic anemias. Folic acid is particularly important during phases of rapid cell division, such as infancy, pregnancy, and erythropoiesis, and plays a protective factor in the development of cancer. As humans are unable to synthesize folic acid endogenously, diet and supplementation is necessary to prevent deficiencies. In order to function properly within the body, folic acid must first be reduced by the enzyme dihydrofolate reductase (DHFR) into the cofactors dihydrofolate (DHF) and tetrahydrofolate (THF). This important pathway, which is required for de novo synthesis of nucleic acids and amino acids, is disrupted by anti-metabolite therapies such as as they function as DHFR inhibitors to prevent DNA synthesis in rapidly dividing cells, and therefore prevent the formation of DHF and THF. In general, folate serum levels below 5 ng/mL indicate folate deficiency, and levels below 2 ng/mL usually result in megaloblastic anemia. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Folate receptor gamma | Humans | binder |
| Folate receptor beta | Humans | binder |
| Folate receptor alpha | Humans |
ADME / PK
| Absorption | Folic acid is absorbed rapidly from the small intestine, primarily from the proximal portion. Naturally occurring conjugated folates are reduced enzymatically to folic acid in the gastrointestinal tract prior to absorption. Folic acid appears in the plasma approximately 15 to 30 minutes after an oral dose; peak levels are generally reached within 1 hour.[FDA Label] |
|---|---|
| Protein binding | Very high to plasma protein |
| Metabolism | Folic acid is metabolized in the liver into the cofactors dihydrofolate (DHF) and tetrahydrofolate (THF) by the enzyme dihydrofolate reductase (DHFR). |
| Route of elimination | After a single oral dose of 100 mcg of folic acid in a limited number of normal adults, only a trace amount of the drug appeared in the urine. An oral dose of 5 mg in 1 study and a dose of 40 mcg/kg of body weight in another study resulted in approximately 50% of the dose appearing in the urine. After a single oral dose of 15 mg, up to 90% of the dose was recovered in the urine. A majority of the metabolic products appeared in the urine after 6 hours; excretion was generally complete within 24 hours. Small amounts of orally administered folic acid have also been recovered in the feces. Folic acid is also excreted in the milk of lactating mothers. |
| Volume of distribution | Tetrahydrofolic acid derivatives are distributed to all body tissues but are stored primarily in the liver. |
Formulation & handling
- Oral formulations require solubilization strategies or dispersible formats due to very low aqueous solubility of this small‑molecule vitamin.
- Parenteral products use aqueous solutions or reconstituted lyophilizates and require protection from light to maintain stability.
- Absorption can be influenced by gastrointestinal conditions, so oral forms are typically designed for robustness across variable pH and food intake.
Regulatory status
| Lifecycle | Patent protections for this API are approaching or have recently lapsed in the US and Canada, indicating a transition toward a more mature market. As generic competition increases, market dynamics in both regions are expected to stabilize around established multisource products. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The folic acid supply landscape is dominated by numerous generic manufacturers and repackagers, with no single originator company driving the market, reflecting its long-established status as a vitamin active ingredient. Branded and private‑label products are widely available in the US and Canada, primarily within multivitamin and nutritional formulations. Patent expiry is long past, and the market is fully open to generic competition. |
|---|
Safety
| Toxicity | IPR-MUS LD<sub>50</sub> 85 mg/kg,IVN-GPG LD<sub>50</sub> 120 mg/kg, IVN-MUS LD<sub>50</sub> 239 mg/kg, IVN-RAT LD<sub>50</sub> 500 mg/kg, IVN-RBT LD<sub>50</sub> 410 mg/kg |
|---|
- Low acute toxicity thresholds across species (e
- G
- , mouse intraperitoneal LD50 ~85 mg/kg
Folic Acid 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.
Folic Acid (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.
Folic Acid API manufacturers & distributors
Compare qualified Folic Acid API suppliers worldwide. We currently have 11 companies offering Folic Acid API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Acura Labs | Producer | India | India | CoA, GMP, MSDS, WC | 18 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, GMP, ISO9001, MSDS, USDMF, WC | 235 products |
| Chemizo Enterprise | Distributor | India | India | CoA | 19 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hebei Jiheng | Producer | China | China | CoA, USDMF | 4 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Pharm Rx Chemical Corp | Distributor | United States | Unknown | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Prachi Pharmaceuticals | Producer | India | India | CoA, FDA, GMP, ISO9001, USDMF, WHO-GMP | 12 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 757 products |
When sending a request, specify which Folic Acid 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 Folic Acid 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 Folic Acid API
Sourcing
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Technical
What is Folic Acid (CAS 59-30-3) used for?
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How does Folic Acid work?
What should someone know about the safety or toxicity profile of Folic Acid?
What are important formulation and handling considerations for Folic Acid as an API?
Is Folic Acid a small molecule?
Are there special stability concerns for oral Folic Acid?
Regulatory
Where is Folic Acid approved or in use globally?
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Pharmaoffer
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