Description

Sodium Feredetate, Folic Acid, and Vitamin B12 Tablets

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 Sodium Feredetate, Folic Acid, and Vitamin B12 Tablets in India. This is a premium Haematinic Formulation designed for the effective treatment of Iron Deficiency Anemia. Unlike conventional iron salts (like Ferrous Sulfate), Sodium Feredetate (Iron EDTA) is a chelated form of iron that offers superior bioavailability with significantly reduced gastrointestinal side effects.

We offer Contract Manufacturing (Third Party) services for this “Gentle Iron” formulation. It is particularly valued in the market because it does not cause teeth staining and has a minimal metallic taste, making it highly acceptable for pregnant women and patients with sensitive stomachs. Healthy Inc manages the export logistics, supplying pharmacy chains and gynecology clinics across the Middle East, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Formulating chelated iron requires specific handling to maintain its complex structure.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Chelation Stability: Sodium Feredetate is an Iron-EDTA chelate. Unlike simple iron salts, the iron is “held” inside the EDTA molecule. We use gentle processing techniques (avoiding excessive heat and acidity during granulation) to ensure this chelate structure remains intact until it reaches the intestine for absorption.

  • Direct Compression/Granulation: We optimize the blend to ensure the low-dose Vitamin B12 and Folic Acid are perfectly distributed alongside the bulkier iron component.

  • Coating: Although Sodium Feredetate has less metallic taste than other irons, we apply a high-quality Sugar Coating or Film Coating to ensure ease of swallowing and moisture protection.

• The Exporter: Healthy Inc

  • Stability: Vitamin B12 is sensitive to light. We recommend Alu-Alu or Amber PVDC Blisters to protect the cyanocobalamin from photodegradation during the shelf life.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We strictly control the content of all three vitamins.

  • Sodium Feredetate: 95-105%

  • Folic Acid: 90-115%

  • Vitamin B12: 90-115%

• Dissolution: We test the release to ensure the iron is available for absorption but releases in a controlled manner to minimize gastric irritation.

• Microbial Limits: Strict bioburden testing is performed to ensure safety.

5. Why Use Sodium Feredetate?

It is the “Smart Choice” for iron therapy.

• Mechanism:

  • Sodium Feredetate: Dissociates in the intestine (not the stomach). The EDTA protects the iron from binding to food inhibitors (like phytates in tea/coffee), leading to 2-3x better absorption than Ferrous Fumarate.

  • Folic Acid: Essential for DNA synthesis and preventing neural tube defects in fetus.

  • Vitamin B12: Crucial for the maturation of red blood cells.

• Key Advantages:

  • No Metallic Taste: Highly palatable.

  • No Teeth Staining: Unlike liquid iron preparations.

  • Less Gastritis: Significantly lower incidence of nausea, vomiting, and constipation compared to ferrous sulfate.

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 Sodium Feredetate Tablets?

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

• Q: Is this safe for pregnancy?

  A: Yes. It is widely prescribed during pregnancy to prevent anemia and support fetal development (due to Folic Acid). The gentle nature of Sodium Feredetate helps pregnant women who often suffer from morning sickness tolerate iron better.

• Q: Can I take this with milk?

  A: Unlike other iron salts, Sodium Feredetate is less inhibited by calcium. However, for maximum absorption, it is still generally best to take it with water or vitamin C-rich juice.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Treatment of Anemia: 1 tablet twice daily.

• Prophylaxis (Prevention): 1 tablet once daily.

• Administration: Swallow whole with water. Best taken after meals to further reduce any chance of stomach upset.

9. Side Effects and Precautions

• Common Side Effects: Dark stools (harmless effect of unabsorbed iron), mild nausea. (Constipation is much rarer than with other irons).

• Contraindications: Hemochromatosis (iron overload), Hemolytic anemia, or allergy to any component.

• Interactions: Decreases absorption of Tetracycline and Quinolone antibiotics (separate doses by 2 hours).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.