In the pharmaceutical industry, Folic Acid 5 mg (Vitamin B9) is classified as a high-dose therapeutic supplement. As a pharmacist, I distinguish this 5 mg strength from the standard 400 mcg (0.4 mg) dose used in daily multivitamins; the 5 mg version is specifically indicated for the treatment of established deficiencies and for high-risk clinical scenarios.
Primary Clinical Uses
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Treatment of Folate-Deficiency Megaloblastic Anemia: Used to restore red blood cell counts when anemia is caused by poor diet, malabsorption syndromes (like Celiac disease), or alcoholism.
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Prevention of Neural Tube Defects (High-Risk): While 400 mcg is standard for most, the 5 mg dose is specifically prescribed for pregnant women with a high risk of NTDs (e.g., those with a previous pregnancy affected by Spina Bifida or those on anti-epileptic medications).
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Methotrexate Toxicity Management: Often prescribed to patients with Rheumatoid Arthritis or Psoriasis taking Methotrexate, to reduce side effects like mouth ulcers and liver toxicity without compromising the drug’s efficacy.
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Chronic Hemolytic Anemia: Used to meet the increased folate demands caused by rapid red blood cell turnover in conditions like Sickle Cell Disease or Thalassemia.
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Drug-Induced Deficiency: To counteract folate depletion caused by long-term use of medications like Phenytoin, Primidone, or Sulfasalazine.
Mechanism of Action
Folic Acid is the precursor to Tetrahydrofolate, which is a vital co-enzyme for several metabolic processes:
Nucleoprotein Synthesis: It is essential for the synthesis of purines and pyrimidines, the building blocks of DNA. This is why it is most critical in rapidly dividing cells, such as those in the bone marrow (producing RBCs) and the developing fetus.
Erythropoiesis: It facilitates the maturation of megaloblasts into healthy, functional erythrocytes (red blood cells).
Amino Acid Metabolism: It plays a role in the conversion of homocysteine to methionine. High levels of homocysteine are linked to cardiovascular risks, which folate helps mitigate.
The Manufacturer’s Perspective: Formulation & Export
From a manufacturing and global trade standpoint, Folic Acid 5 mg is a stable, high-volume product:
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API Quality: As a WHO-GMP manufacturer, we ensure the API meets BP/USP/IP standards. Folic Acid is relatively stable but sensitive to light and heat.
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Formulation & Color: These tablets are typically small and yellow (the natural color of the API). We utilize high-quality binders to ensure rapid disintegration and optimal bioavailability.
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Stability for Export: We utilize PVC/PVDC or Alu-Alu blister packaging to ensure a 36-month shelf life. This is a staple product for export to Zone IVb regions (Africa, SE Asia, and the Middle East).
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B2B & Public Health Tenders: Folic Acid 5 mg is a core item in maternal health and essential medicine tenders. Our Mumbai-based facility provides full CTD/eCTD Dossiers to support international registration and B2B marketplace listings.