Description

Cholecalciferol Granules Sachet (60,000 IU)

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 Cholecalciferol (Vitamin D3) Granules in India. Vitamin D3 is the “Sunshine Vitamin,” crucial for maintaining healthy bones, teeth, and a robust immune system. In a world where indoor lifestyles and sunscreen use have led to a global epidemic of Vitamin D deficiency, high-dose oral supplementation is the standard medical intervention.

We offer Contract Manufacturing (Third Party) services for this high-demand nutraceutical/pharmaceutical product. Our WHO-GMP certified facility in Mumbai utilizes advanced Microencapsulation Technology to produce lipid-stabilized granules. This ensures that the Vitamin D3 remains potent and does not degrade due to oxidation. Packed in convenient, moisture-proof sachets with pleasant flavors (Orange/Lemon), our product is designed for high patient compliance—simply mix with milk or water for a weekly “bone-booster.” Healthy Inc manages the export logistics, supplying retail pharmacies, orthopedic clinics, and wellness chains across the Middle East, CIS countries, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Protecting the unstable “Sunshine Vitamin.”

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Microencapsulation: Vitamin D3 is extremely sensitive to oxygen, light, and humidity. It degrades rapidly if exposed. We use Microencapsulated Vitamin D3, where the active oil droplets are trapped inside a protective starch/gelatin shell. This ensures the 60,000 IU stated on the label is exactly what the patient receives, even after months of storage.

  • Lipid Matrix: Vitamin D is fat-soluble. Our granules are formulated with a lipid carrier that helps absorption even if the patient forgets to take it with a fatty meal.

  • Taste Masking: Raw Vitamin D can have a soapy taste. We use high-quality sweeteners and spray-dried flavors to create a pleasant drink that appeals to both children and adults.

• The Exporter: Healthy Inc

  • Compliance Packaging: We offer “Weekly Packs” (e.g., strips of 4 or 8 sachets) designed for the standard 8-week loading dose regimen prescribed by orthopedists.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We confirm the potency is strictly within 90-125% of the label claim (Vitamin D has a wider overage allowance due to stability).

• Moisture Content: Strictly controlled (< 5%) to prevent clumping of granules.

• Microbial Limits: We strictly monitor for pathogens (Salmonella, E. coli) as this is a non-sterile oral powder.

5. Why Use Cholecalciferol Sachets?

The weekly power-dose for bones.

• Mechanism:

  1. Calcium Absorption: Vitamin D acts like a key that unlocks the gut to allow Calcium and Phosphorus to enter the bloodstream. Without D3, calcium passes right through the body.

  2. Bone Mineralization: It directs calcium into the bone matrix, preventing Rickets (in kids) and Osteoporosis (in adults).

  3. Immunity: Activates T-cells to fight infections.

• Key Indications:

  • Vitamin D Deficiency: Treatment of severe deficiency (< 20 ng/mL).

  • Osteoporosis: Prevention of fractures in post-menopausal women and the elderly.

  • Hypoparathyroidism: Managing low calcium levels.

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 Cholecalciferol Sachets?

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

• Q: How do I take it?

  A: With Milk. Pour the granules into a glass of milk (or water). Milk is preferred because the fat helps your body absorb the vitamin.

• Q: Is it a daily medicine?

  A: No. The 60,000 IU sachet is a high dose usually taken Once a Week. Taking it daily can lead to toxicity. Always follow your doctor’s schedule.

• Q: Is it Vegetarian?

  A: Check the label. Most D3 is derived from Lanolin (sheep’s wool grease), so it is vegetarian-friendly but not vegan. Lichen-based (Vegan) D3 is available upon special request.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Treatment of Deficiency: 60,000 IU once weekly for 8 weeks, followed by a maintenance dose (e.g., 60k once a month).

• Administration: Empty contents of sachet into a glass. Add milk or water. Stir and drink immediately. Best taken with the largest meal of the day.

9. Side Effects and Precautions

• Hypervitaminosis D: Overdose causes Hypercalcemia (too much calcium in blood), leading to nausea, vomiting, kidney stones, and confusion.

• Kidney Stones: Use caution in patients with a history of calcium kidney stones.

• Interaction: Reduces absorption if taken with Orlistat (weight loss drug) or Cholestyramine.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep sachets sealed until use. Moisture destroys Vitamin D.