Calcium Citrate With Vitamin D3 Tablets

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Description

Calcium Citrate & Vitamin D3 Tablets

(1000mg / 1200mg)

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 Calcium Citrate and Vitamin D3 Tablets in India. While Calcium Carbonate is the standard, Calcium Citrate is the Premium Choice for patients with low stomach acid (e.g., elderly patients or those on PPIs) or a history of kidney stones.

Unlike Carbonate, Calcium Citrate does not require stomach acid for absorption, making it highly bioavailable and effective even when taken on an empty stomach. Combined with Vitamin D3, which is essential for calcium absorption, this formulation is the preferred supplement for Post-Menopausal Osteoporosis and patients with hypochlorhydria.

We offer Contract Manufacturing (Third Party) services for this high-value nutraceutical. Calcium Citrate is a bulky molecule. Our WHO-GMP certified facility in Mumbai utilizes advanced High-Density Granulation technology to compress the large volume of powder into a manageable, easy-to-swallow tablet without compromising its rapid disintegration. Healthy Inc manages the export logistics, supplying premium pharmacy chains and orthopedic clinics across the USA, Europe, and Southeast Asia.

2. Product Specifications

ParameterSpecification
Product NameCalcium Citrate & Vitamin D3 Tablets
Generic NameCalcium Citrate Malate and Vitamin D3 Tablets USP / BP
CompositionCalcium Citrate 1000mg / 1200mg (Eq. to Elemental Calcium 200mg / 250mg) + Vitamin D3 200 IU / 400 IU
Dosage FormFilm Coated Tablet (White / Oblong / Modified Capsule Shape)
StandardUSP / BP / IP Compliant
Therapeutic ClassNutritional Supplement / Bone Health
Shelf Life24 to 36 Months
Packaging10×15 Blister / 60s, 100s Bottle

3. Manufacturing Technology

Bioavailability without the acid.

  • The Manufacturer: Healthy Life Pharma Pvt. Ltd.

    • Independent Absorption: Calcium Citrate is water-soluble. We formulate it to disintegrate rapidly, allowing the calcium to ionize immediately in the stomach regardless of pH. This is critical for elderly patients whose stomach acid production is low.

    • Kidney Stone Safety: Unlike Carbonate, Citrate actually inhibits crystallization. We market this specifically as the “Kidney-Safe Calcium” for patients prone to oxalate stones.

    • Vitamin D3 Stability: We use Micro-Encapsulated Vitamin D3 to protect it from oxidation during the tablet compression process and shelf storage, ensuring the label claim is met until the expiry date.

  • The Exporter: Healthy Inc

    • Premium Packaging: We offer high-quality HDPE bottles with induction sealing and silica gel desiccants to protect the tablets from moisture, crucial for maintaining the stability of the Citrate salt.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

  • Assay: We confirm the elemental calcium content is strictly controlled. (Note: 1000mg Citrate salt yields ~210mg Elemental Calcium).

  • Dissolution: We test release profiles in neutral pH media (unlike Carbonate which needs acid) to verify its superior solubility profile.

  • Lead Content: We strictly test for heavy metals to ensuring the calcium source is pure and safe for long-term daily consumption.

5. Why Use Calcium Citrate?

The gentle, absorbable calcium.

  • Mechanism:

    1. Absorption: Citrate is an organic salt. It passes through the intestinal wall via paracellular transport more easily than inorganic Carbonate.

    2. Bioavailability: It is ~2.5 times more bioavailable than Calcium Carbonate when taken on an empty stomach.

    3. Metabolism: The Citrate part is metabolized to bicarbonate, which can help buffer acid in the blood, potentially benefiting bone density further.

  • Key Indications:

    • Osteoporosis: In elderly patients (who often have low stomach acid).

    • Patients on Acid Blockers: People taking Omeprazole or Pantoprazole (which reduce stomach acid) cannot absorb Calcium Carbonate well; they must take Citrate.

    • Kidney Stone History: Safer option than Carbonate.

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: Is it Citracal?

    A: Citracal is the brand name (Bayer). We manufacture the Generic Equivalent (Calcium Citrate + D3).

  • Q: Do I need to take it with food?

    A: No. That is the main advantage. You can take it anytime, with or without food, and it will still be absorbed perfectly.

  • Q: Why is the tablet big?

    A: Density. Calcium Citrate is a fluffy powder with less elemental calcium per gram than Carbonate. You need a larger tablet to get the same amount of calcium.


CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

  • Adults: 2 tablets daily (Total ~500mg Elemental Calcium).

  • Timing: Can be taken at any time of day.

  • Maximum Dose: Do not exceed 2500mg Elemental Calcium per day.

9. Side Effects and Precautions

  • Gastrointestinal: Much less constipation and bloating compared to Calcium Carbonate.

  • Interactions: Can bind to Bisphosphonates, Tetracyclines, and Levothyroxine. Separate doses by 4 hours.

  • Hypercalcemia: Monitor blood calcium levels in patients with renal impairment.

10. Storage Instructions

  • Store below 25°C in a dry place.

  • Keep container tightly closed.