Description

Iron & Folic Acid Tablets (IFA)

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 Iron and Folic Acid (IFA) Tablets in India. This fixed-dose combination is the global “Gold Standard” for the prevention and treatment of Iron Deficiency Anemia (IDA) and for supporting maternal health during pregnancy. It combines Iron (essential for Hemoglobin) and Folic Acid (essential for preventing Neural Tube Defects in the fetus).

We offer Contract Manufacturing (Third Party) services for high-volume public health tenders and private label brands. Iron salts are highly reactive and have a strong metallic taste. Our WHO-GMP certified facility in Mumbai utilizes traditional Sugar Coating (Red/Maroon color) or advanced Film Coating to completely mask the taste and protect the ingredients from oxidation. Healthy Inc manages the export logistics, supplying UNICEF/WHO-compliant tenders, antenatal clinics, and pharmacy chains across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Taste masking and stability are paramount.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Taste Masking (Sugar Coating): Iron salts are intensely metallic and astringent. We specialize in Sugar Coating, applying multiple layers of sucrose and color to create a perfectly smooth, sweet, and elegant tablet that enhances compliance, especially among pregnant women sensitive to nausea.

  • Oxidation Control: Iron (Ferrous form) easily oxidizes to the inactive Ferric form. We manufacture in low-humidity environments and use specific antioxidants in the formulation to maintain the Ferrous state, ensuring maximum absorption.

  • Segregation: Iron dust can stain facility walls and cross-contaminate other products. We use dedicated, segregated granulation suites with high-efficiency dust collection systems to ensure purity.

• The Exporter: Healthy Inc

  • Tender Packaging: We are equipped to handle large-scale “Hospital Packs” (1000s HDPE Jars) or “Community Health Worker Kits” required for government anemia control programs (WIFS – Weekly Iron Folic Acid Supplementation).

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure the iron becomes available for absorption in the upper GI tract.

• Assay: We confirm the potency of both Iron and Folic Acid is strictly within 90-110% of the label claim.

• Limit of Ferric Iron: We test to ensure the iron has not oxidized into the poorly absorbed Ferric ($Fe^{3+}$) form during shelf life.

5. Why Use IFA?

The dual-action blood builder.

• Mechanism (Iron): Iron is a core component of Hemoglobin (which carries oxygen in blood) and Myoglobin (in muscles). Supplementation restores iron stores (Ferritin) and corrects anemia.

• Mechanism (Folic Acid): Folic Acid (Vitamin B9) is required for DNA synthesis and cell division. It is critical in the first trimester of pregnancy to close the fetus’s neural tube, preventing birth defects like Spina Bifida.

• Key Indications:

  • Pregnancy: Prophylaxis against anemia and birth defects.

  • Iron Deficiency Anemia: Treatment of fatigue, pallor, and weakness caused by low blood count.

  • Adolescent Girls: Weekly supplementation to prevent anemia during growth spurts and menstruation.

     

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• 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 Iron Folic Acid Tablets?

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

• Q: Why is the tablet red?

  A: Red is the international color code for Iron supplements, making it easy for patients to identify.

• Q: Can I take it with milk?

  A: NO. Calcium in milk blocks iron absorption. Take it with water or Orange Juice (Vitamin C helps absorption).

• Q: Why is my stool black?

  A: This is completely normal and harmless. It is just unabsorbed iron leaving the body. Do not worry.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Prophylaxis (Pregnancy): One tablet (60mg/400mcg) daily starting from the first trimester.

• Treatment (Anemia): One tablet twice daily (or as prescribed).

• Administration: Swallow whole. Best taken on an empty stomach for max absorption, but can be taken with food if it causes stomach upset.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, constipation, dark stools, or abdominal pain. (Taking with food reduces nausea but slightly lowers absorption).

• Staining: If chewed, can stain teeth. Swallow whole.

• Contraindications: Hemochromatosis (iron overload disorder) or Hemolytic Anemia.

• Interaction: Antacids, Calcium, and Tetracyclines reduce absorption. Separate by 2 hours.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture. (Iron is very hygroscopic).