In the pharmaceutical industry, the combination of Ferrous Fumarate and Folic Acid is a foundational hematinic therapy. As a pharmacist and manufacturer, I view this formulation as the “Gold Standard” for addressing iron-deficiency anemia, particularly in maternal health and pediatric recovery.

At your WHO-GMP facility in Mumbai, this FDC (Fixed-Dose Combination) is likely one of your high-volume SKUs for both government tenders and international export to regions focused on prenatal care.

Primary Clinical Indications

This combination is used to treat and prevent “Nutritional Anemias”:

• Pregnancy & Lactation: Used as a routine prenatal supplement to prevent maternal anemia and support fetal neural tube development.

• Iron Deficiency Anemia (IDA): Specifically for cases where blood iron levels are low due to chronic blood loss, poor diet, or malabsorption.

• Megaloblastic Anemia: The Folic Acid component treats anemia caused by a deficiency of Vitamin B9, which is essential for healthy red blood cell (RBC) production.

• General Convalescence: Used for recovery after surgery or significant illness where blood volume needs to be restored.

Mechanism: The “Blood Building” Synergy

This formulation targets two different stages of RBC development:

Ferrous Fumarate (The Building Block): Iron is the essential core of the hemoglobin molecule. The fumarate salt is preferred because it contains approximately 33% elemental iron, making it more potent than ferrous sulfate (~20%) while often being better tolerated by the stomach.

Folic Acid (The Blueprint): Folic Acid is a co-enzyme required for DNA synthesis. Without it, the body produces “giant,” immature red blood cells that cannot carry oxygen effectively.

Result: Together, they ensure the body produces a sufficient quantity of mature, oxygen-rich red blood cells.

The Pharmacist’s “Technical Warning”

• The “Black Stool” Phenomenon: Advise patients that iron supplements will turn stools dark green or black. This is harmless but often causes unnecessary alarm.

• The “Vitamin C” Boost: Suggest taking the tablet with a glass of orange juice. Vitamin C significantly enhances iron absorption.

• The “Dairy & Tea” Blockade: Calcium (milk), tannins (tea), and caffeine inhibit iron absorption. A 2-hour gap is mandatory.

• Constipation: Iron is notorious for causing constipation. Advise increased water intake and dietary fiber.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• The “Elemental Iron” USP: On your digital marketplace, clearly state the Elemental Iron content (e.g., “Contains 100mg of Elemental Iron”). B2B buyers and tenders look for this specific technical data over the raw salt weight.

• Stability for Export: Ferrous Fumarate is relatively stable, but Folic Acid is sensitive to light. Utilizing Alu-Alu or Opaque Blister packaging is essential for a 36-month shelf life in Zone IVb tropical regions.

• Dossier Support: We provide full WHO-standard CTD/eCTD Dossiers to support your firm’s registration in international Maternal & Child Health (MCH) tenders.