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Ferrous Fumarate & Folic Acid Tablets

Product: Ferrous Fumarate & Folic Acid Tablets

Composition status: Ferrous fumarate strength not confirmed. Supplied formulations below contain dried ferrous sulphate instead.

Usage: Treat or prevent iron deficiency when indicated.

Category: Generic Drugs and Medicine

Therapeutic Category: Hematinic / Iron and Folic Acid Supplement

Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations

Product Information

Ferrous Fumarate & Folic Acid Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Ferrous Fumarate and Folic Acid Tablets — Formulation Review

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. describes iron-and-folic-acid supplements for prevention and treatment of iron deficiency when clinically indicated. Important formulation distinction: The supplied product title says Ferrous Fumarate & Folic Acid Tablets, but every detailed tablet composition supplied is for Dried Ferrous Sulphate + Folic Acid. These are different iron salts and must not be substituted in product labeling. The sulphate variants are listed below exactly as supplied; no specific fumarate tablet composition is verified here.

2. Product Specifications

PresentationStandardIron saltDeclared elemental ironFolic acidForm
Standard IFAIPDried Ferrous Sulphate 150 mg45 mg0.4 mgEnteric-coated; Indigo Carmine
IFA Large / Iron-FolateIPDried Ferrous Sulphate 335 mg100 mg0.5 mgEnteric- or film-coated; colour varies by product
PediatricIPDried Ferrous Sulphate 67 mg20 mg100 mcgFilm-coated
Ferro ForceBPDried Ferrous Sulphate 200 mg60 mg0.25 mgSugar-coated
FESFO-EIPDried Ferrous Sulphate 100 mg30 mg0.1 mgEnteric-coated; Indigo Carmine Lake

Separate ferrous fumarate product concept: Ferrous fumarate and folic acid tablets may be formulated in various strengths, but the supplied text does not establish a registered fumarate composition, coating, elemental-iron declaration, pack size or shelf life. These must be confirmed before marketing this page as a specific fumarate product.

Elemental iron equivalences in the table are the user-supplied declarations; verify each against the approved formulation and iron salt grade.

3. Manufacturing Technology

Formulation development for iron and folic acid tablets addresses uniform distribution of the low-dose folic acid ingredient, appropriate coating, packaging protection and stability. Film or sugar coating can help with taste masking, but cannot be assumed to eliminate gastrointestinal irritation. Enteric coating is a distinct release design and may affect iron absorption.

4. Quality Assurance

Finished-product specifications may include identity, assay for iron and folic acid, uniformity, dissolution or disintegration as applicable, impurities, microbial limits and stability testing. Acceptance limits and shelf life depend on the registered product.

5. Pharmacology and Clinical Use

Iron is essential for haemoglobin synthesis. Folic acid supports DNA synthesis and normal red-cell production; adequate folate intake around conception helps reduce neural-tube-defect risk. Iron-folate supplementation is appropriate for diagnosed iron deficiency and selected public-health or maternal-care indications. Not all anaemia is caused by iron deficiency.

6. Export and Regulatory Support

Product-specific CTD/ACTD dossiers, COA and regulatory certificates may be provided subject to availability. The exact iron salt, strength, elemental-iron equivalence and approved label must match the destination-market registration.

7. Frequently Asked Questions

Are ferrous fumarate and ferrous sulphate the same?
No. Both supply iron, but they are different salts. Their elemental-iron content per milligram of salt differs.

Why can stools become dark?
Dark stools are common with oral iron, but black tarry stools with weakness or other symptoms require urgent medical evaluation.

Can iron be taken with milk?
Calcium can reduce iron absorption. Follow clinician or label instructions about separating iron from calcium, antacids and other medicines.

8. Dosage and Administration

Iron and folic acid doses vary by age, pregnancy status, laboratory results and indication. Do not interchange paediatric and adult strengths or sulphate and fumarate salt quantities without confirming elemental-iron equivalence. Follow the approved label; do not crush enteric-coated tablets unless specifically permitted.

9. Side Effects and Precautions

  • Possible effects include nausea, abdominal discomfort, constipation, diarrhoea and dark stools.
  • Iron can interact with levothyroxine, tetracyclines, fluoroquinolones and other products; dosing separation may be necessary.
  • Assess iron status before supplementation in iron-overload disorders or anaemia not caused by iron deficiency.
  • Iron overdose can be fatal in children. Keep tablets securely out of reach.

10. Storage Instructions

Store in original protective packaging under the conditions stated on the approved label. Protect from excessive heat and moisture and keep out of reach of children.