Description

Dried Ferrous Sulfate & Folic Acid Tablets

(Ferrous Sulfate 200mg + Folic Acid 0.5mg / 1mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Dried Ferrous Sulfate and Folic Acid Tablets in India. This is the classic “Gold Standard” hematinic formulation used worldwide for the prevention and treatment of Iron Deficiency Anemia, especially during Pregnancy.

Unlike “Ferrous Sulfate Heptahydrate” (which is wet and unstable), we use Dried Ferrous Sulfate (Exsiccated), which contains a higher concentration of Elemental Iron (~30-33%) per milligram and offers superior stability in tropical climates. Combined with Folic Acid, this tablet supports both Hemoglobin formation and red blood cell maturation, preventing neural tube defects in the developing fetus.

We offer Contract Manufacturing (Third Party) services for this high-volume essential medicine. Iron tablets are notorious for their metallic taste and gastric irritation. Our WHO-GMP certified facility in Mumbai utilizes advanced Sugar Coating or Enteric Coating technology to completely mask the taste and delay release until the intestine, improving patient compliance significantly. Healthy Inc manages the export logistics, supplying UNICEF tenders, government health ministries, and NGOs across Africa and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Stable iron for harsh climates.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • “Dried” Stability: We strictly use Exsiccated (Dried) Ferrous Sulfate. Standard “Heptahydrate” (Green Vitriol) melts at low temperatures and oxidizes easily. Our Dried version is stable up to much higher temperatures, ensuring the tablet doesn’t “sweat” or degrade during shipping in hot containers.

  • Gastric Protection: To prevent the nausea often caused by iron, we apply a Sub-Coat followed by a robust Sugar Coat. This barrier prevents the iron from touching the stomach lining directly, reducing irritation and vomiting.

  • Folic Acid Overages: Folic acid degrades in the presence of iron salts. We use specific stabilizing excipients and appropriate overages to ensure the Folic Acid content remains 100% potent at the end of the 3-year shelf life.

• The Exporter: Healthy Inc

  • Tender Packs: This is a top-priority item for maternal health tenders. We offer cost-effective Bulk Jars (1000s) and PVDC Blisters that meet the stringent price and quality requirements of global NGOs.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Elemental Iron Calculation: We meticulously verify that the 200mg of Dried Sulfate yields exactly 65mg of Elemental Iron, as this is the therapeutic dose required by WHO guidelines.

• Dissolution: We test release profiles to ensure the coating dissolves within 60 minutes in the intestine (simulated gastric fluid) for maximum absorption.

• Oxidation Test: We test for Ferric (Fe3+) impurities. Ferrous (Fe2+) is the absorbable form; if it oxidizes to Ferric, it becomes useless. Our process ensures >98% remains in the Ferrous state.

5. Why Use Dried Ferrous Sulfate?

Potent and proven.

• Mechanism:

  • Elemental Iron: It is the core component of Heme. Without it, the body cannot make Hemoglobin to carry oxygen.

  • Folic Acid: Essential for DNA synthesis. It prevents the bone marrow from producing “giant” but empty red blood cells (Megaloblastic Anemia).

• Key Indications:

  • Pregnancy Prophylaxis: WHO recommends daily iron/folic acid for all pregnant women to prevent low birth weight and maternal anemia.

  • Iron Deficiency Anemia: Treatment of fatigue, pallor, and breathlessness.

  • Post-Partum: Replenishing iron stores after bleeding during childbirth.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD available.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures these tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Why is the tablet red?

  A: Identification. Iron tablets are traditionally sugar-coated red or brown to distinguish them from other medicines and to mask the dark color of the iron core.

• Q: Is “Dried” Sulfate better?

  A: Yes. It is more concentrated (more iron per mg) and much more stable in hot weather than the wet “Heptahydrate” form.

• Q: Why can’t I take it with milk?

  A: Calcium blocks Iron. Milk, cheese, and yogurt prevent your body from absorbing the iron. Take it with water or orange juice instead.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Prevention (Pregnancy): 1 tablet daily (providing 60-65mg elemental iron).

• Treatment (Anemia): 1 tablet twice daily, or as directed by a physician.

• Administration: Best taken on an empty stomach (1 hour before meals). If nausea occurs, take with a meal (avoiding dairy/tea).

9. Side Effects and Precautions

• Gastrointestinal: Nausea, abdominal pain, constipation, dark/black stools (harmless).

• Toxicity: Toxic to children. Keep out of reach. Accidental overdose is a medical emergency.

• Interactions: Antacids, Calcium, and Tetracyclines decrease absorption. Vitamin C increases absorption.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from light and moisture.