In the pharmaceutical industry, Ferrous Sulphate is the most widely prescribed oral iron supplement for the treatment and prevention of iron-deficiency anemia. As a pharmacist and manufacturer, I view Ferrous Sulphate as the “gold standard” for iron salts due to its high elemental iron content and cost-effective production profile.

Primary Clinical Uses

• Iron-Deficiency Anemia (IDA): The primary indication for treating low hemoglobin levels caused by blood loss, poor diet, or malabsorption issues.

• Prophylaxis during Pregnancy: Routinely prescribed to pregnant women to meet the increased iron demands of the developing fetus and to prevent maternal anemia.

• Renal Failure: Used in patients with chronic kidney disease (CKD), particularly those receiving erythropoietin therapy, to maintain adequate iron stores.

• Pediatric Development: Used to treat iron deficiency in growing children (often in liquid or smaller tablet formats).

Mechanism of Action: Restoring Hemoglobin

Iron is a critical component of hemoglobin, the protein in red blood cells responsible for transporting oxygen.

Absorption: When ingested, Ferrous Sulphate releases ferrous ions ($Fe^{2+}$) in the duodenum and jejunum.

Transport: Once absorbed into the mucosal cells, the iron is either stored as ferritin or transported into the blood via transferrin.

Erythropoiesis: This iron is carried to the bone marrow, where it is incorporated into the heme group of hemoglobin, facilitating the production of healthy, oxygen-carrying red blood cells.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Ferrous Sulphate requires specific technical handling to ensure stability and patient compliance:

• Elemental Iron Calculation: A standard 200 mg Ferrous Sulphate (dried) tablet typically yields approximately 65 mg of elemental iron. We ensure our labeling clearly states both the salt weight and the elemental iron content to meet international regulatory standards.

• Enteric & Film Coating: To mitigate common GI side effects (nausea, constipation, and black stools), as a WHO-GMP manufacturer, we often utilize enteric coating. This ensures the tablet bypasses the stomach and releases the iron in the small intestine, significantly improving patient tolerance.

• Stability (Oxidation Prevention): Ferrous iron can easily oxidize to ferric iron ($Fe^{3+}$), which is less absorbable. We utilize Alu-Alu or high-barrier PVC/PVDC blister packaging and include antioxidants in the formulation to ensure a 36-month shelf life for export to Zone IVb regions.

• B2B & Government Tenders: This is a high-volume product for maternal health programs and NGOs. Our Mumbai facility provides full CTD/eCTD Dossiers to support large-scale international supply.