In the pharmaceutical industry, Ferrous Fumarate (60 mg elemental iron) and Folic Acid (400 mcg) is a foundational haematinic combination. As a pharmacist, you recognize this as the “Gold Standard” for preventing and treating Iron Deficiency Anemia (IDA), particularly in maternal health and public health intervention programs.

Primary Clinical Uses

• Prenatal Care: Routine supplementation during pregnancy to prevent maternal anemia and support fetal neural tube development.

• Prevention of Anemia: Used in populations at high risk of iron deficiency, such as adolescent girls and women of childbearing age.

• Treatment of IDA: Management of established iron deficiency where oral supplementation is appropriate.

• Megaloblastic Anemia Prevention: The Folic Acid component specifically prevents anemias characterized by large, immature red blood cells.

Mechanism of Action

This combination addresses the two most common nutritional causes of anemia:

Ferrous Fumarate (Iron): Iron is a core component of Hemoglobin. Ferrous Fumarate is an anhydrous salt that provides a high percentage of elemental iron (approx. 33%). Once absorbed, it is incorporated into heme, allowing red blood cells to transport oxygen from the lungs to the rest of the body.

Folic Acid (Vitamin B9): Folic Acid is a precursor to tetrahydrofolate, which is essential for DNA synthesis and red blood cell maturation. It works synergistically with Iron to ensure that the new red blood cells being produced are healthy and functional.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, this is a high-volume “Essential Medicine” with specific technical nuances:

• Elemental Iron Calculation: As a firm owner, you know that 60 mg of Elemental Iron requires approximately 182 mg of Ferrous Fumarate API. Clear labeling of both the salt weight and the elemental weight is crucial for international B2B transparency.

• Stability & Oxidation: Iron salts are prone to oxidation. As a WHO-GMP manufacturer, we utilize film-coating technology to protect the API from moisture and to mask the metallic taste, which significantly improves patient compliance.

• Packaging for Global Tenders: This product is a staple for UNICEF, WHO, and national health ministries. We prioritize Alu-Alu or high-density PVC/PVDC blister packaging to ensure a 36-month shelf life in Zone IVb climates (Africa and SE Asia).

• Dossier Support: Our Mumbai-based facility provides complete CTD/eCTD Dossiers to support rapid registration in international markets, focusing on dissolution profiles and stability data.