Description

Folic Acid Tablets (5mg / 1mg / 400mcg)

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 Folic Acid Tablets in India. Folic Acid (Vitamin B9) is a critical water-soluble vitamin essential for DNA synthesis, cell division, and the maturation of red blood cells. It is globally recognized as a mandatory supplement for Women of Childbearing Age to prevent neural tube defects (like Spina Bifida) in the developing fetus and is the primary treatment for Megaloblastic Anemia caused by folate deficiency.

We offer Contract Manufacturing (Third Party) services for this high-volume essential medicine. Folic Acid is sensitive to light and heat. Our WHO-GMP certified facility in Mumbai utilizes controlled manufacturing environments and light-resistant packaging to ensure the vitamin remains potent throughout its shelf life. Healthy Inc manages the export logistics, supplying antenatal clinics, government health programs, and pharmacy chains across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Ensuring stability for a sensitive vitamin.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Content Uniformity: For lower strengths like 400mcg (0.4mg), achieving a uniform mix is critical. We use Geometric Dilution blending techniques to ensure that every single tablet contains the exact micro-dose required for fetal protection.

  • Direct Compression: We utilize direct compression grades of Folic Acid to minimize exposure to moisture and heat during processing, preserving the stability of the vitamin molecule.

  • Light Protection: Folic Acid degrades rapidly in sunlight. We formulate the tablets with specific yellow colorants (like Tartrazine or Iron Oxide Yellow) and pack them in Amber PVC Blisters or opaque containers to block UV light.

• The Exporter: Healthy Inc

  • Public Health Packs: We specialize in supplying bulk packs (1000s) for national “WIFS” (Weekly Iron and Folic Acid Supplementation) programs aimed at reducing anemia in adolescent girls.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 45 minutes.

• Assay: We confirm the potency is strictly within 90-115% of the label claim.

• Related Substances: We strictly monitor for degradation products (N-(4-aminobenzoyl)-L-glutamic acid) which can form if the product is not stored correctly.

5. Why Use Folic Acid?

Building blocks for DNA and blood.

• Mechanism: Folic Acid is converted in the body to Tetrahydrofolate, a coenzyme necessary for the synthesis of purines and pyrimidines (DNA building blocks). It is vital for Erythropoiesis (production of red blood cells) and for the rapid cell division that occurs during fetal development.

• Key Indications:

  • Pregnancy: Prevention of Neural Tube Defects (brain/spine defects) in the fetus. Must be taken before conception and during the first trimester.

  • Megaloblastic Anemia: Treatment of anemia where red blood cells are larger than normal (macrocytic) due to folate deficiency.

  • Methotrexate Toxicity: Used as a “Rescue” therapy (Leucovorin) or supplement to reduce side effects of Methotrexate treatment.

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 Folic Acid Tablets?

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

• Q: When should I start taking it for pregnancy?

  A: Ideally 1 month BEFORE conception. The neural tube closes in the first 28 days of pregnancy, often before a woman knows she is pregnant.

• Q: Is 5mg too much?

  A: It depends. 5mg is a “Therapeutic Dose” for treating anemia or for high-risk pregnancies. The standard daily supplement is 400mcg (0.4mg). Always follow the doctor’s prescription.

• Q: Does it hide B12 deficiency?

  A: Yes. High doses of Folic Acid can correct the anemia caused by Vitamin B12 deficiency but cannot fix the nerve damage. If you have anemia, doctors usually test both B12 and Folate levels.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Megaloblastic Anemia: 5mg daily for 4 months (or until hematologic recovery).

• Pregnancy (Prophylaxis): 400mcg (0.4mg) to 800mcg (0.8mg) daily.

• Pregnancy (High Risk History): 4mg or 5mg daily starting 1 month before conception.

• Administration: Swallow whole with water.

9. Side Effects and Precautions

• General: Extremely well-tolerated. Rare allergic reactions.

• Gastrointestinal: Mild nausea, loss of appetite, or bloating (rare).

• Interaction: Can decrease the effectiveness of Phenytoin (seizure medicine).

• Masking Effect: Caution in undiagnosed Pernicious Anemia (B12 deficiency); Folic acid corrects the blood picture but neurological damage continues.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light. (Tablets will darken if exposed).