Cholecalciferol (Vitamin D3) Injection

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Cholecalciferol (Vitamin D3) injection is a sterile, fat-soluble liquid used to treat severe Vitamin D deficiency, particularly when oral absorption is impaired. Unlike many other injections, this is an oily solution because Vitamin D3 is not water-soluble.

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Description

Cholecalciferol (Vitamin D3) Injection

Healthy Inc is a specialized global supplier and exporter of high-potency fat-soluble vitamins. We provide high-purity Cholecalciferol (Vitamin D3) Injection (300,000 IU / 600,000 IU), sourced from WHO–GMP certified sterile injectable facilities. This “Bone & Immunity Builder” is a top export to orthopedic centers, endocrinology clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the definitive mega-dose therapy for severe Vitamin D deficiency, osteomalacia, and rickets.


Product Overview

This formulation contains Cholecalciferol, a secosteroid pro-hormone that is metabolically activated in the body to regulate calcium and phosphorus homeostasis.

The “Calcium Controller” Specialist:

  • Mechanism (The “Absorption” Key): Cholecalciferol is converted in the liver to calcifediol (25-OH Vitamin D3) and then in the kidneys to its active form, Calcitriol (1,25-dihydroxycholecalciferol). Calcitriol binds to cellular receptors in the intestines, dramatically increasing the absorption of dietary calcium and phosphorus into the bloodstream.
  • Bone Mineralization: Without adequate Vitamin D, the body cannot absorb enough calcium, leading it to steal calcium from the skeleton. This mega-dose injection halts this process, promoting rapid bone remineralization in patients with Osteomalacia (adults) or Rickets (children).
  • Bypass Malabsorption: Because it is administered via intramuscular injection, it completely bypasses the digestive tract. This is critical for patients with severe malabsorption syndromes (e.g., Crohn’s disease, celiac disease, or post-bariatric surgery) who cannot absorb oral Vitamin D supplements.

Product Composition & Strength

We supply this product as a Sterile Oily Solution in glass ampoules.

Active IngredientStrengthVehicle
Cholecalciferol USP/BP (Vitamin D3)300,000 IU / 1 ml (7.5 mg)Oily Base (Arachis or Sesame Oil)
Cholecalciferol USP/BP (Vitamin D3)600,000 IU / 1 ml (15 mg)Oily Base (Arachis or Sesame Oil)
ExcipientsBHT / Benzyl AlcoholAntioxidant / Preservative

*Pack Sizes: Tray of 5 Ampoules, 10 Ampoules, or 50 Ampoules.


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

HS Code3004.50.90 (Other medicaments containing vitamins)
Dosage FormInjection (Viscous Oily Solution)
PackagingType I Amber Glass Ampoule (Light Sensitive)
StorageStore below 25°C. Protect from Light. Do Not Freeze.
CertificatesWHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Lipophilic Stability: Vitamin D3 is highly prone to oxidation. We utilize nitrogen flushing during the filling process to displace oxygen in the ampoule headspace, and we incorporate potent antioxidants (like BHT) into the purified oil vehicle to guarantee a long shelf-life.
  • Viscous Liquid Filling: Our advanced aseptic filling lines are specifically calibrated for high-viscosity oily injections, ensuring exact volume delivery (1.0 ml to 1.1 ml) without splashing or under-filling, guaranteeing the patient receives the exact mega-dose required.

Therapeutic Indications (Human Use)

Indicated for the treatment and prevention of Vitamin D deficiency:

  • Severe Vitamin D Deficiency: Rapid correction of dangerously low 25(OH)D levels.
  • Osteomalacia & Rickets: Curative treatment for bone softening diseases.
  • Osteoporosis: As an adjunct to antiresorptive therapies (like Bisphosphonates) to ensure adequate calcium substrate.
  • Hypoparathyroidism: Management of hypocalcemia.
  • Malabsorption Syndromes: Intestinal diseases preventing oral absorption of fat-soluble vitamins.

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

  • Route: Deep Intramuscular (IM) Injection ONLY. (Never administer Intravenously).
  • Deficiency Treatment (Adults): 300,000 IU to 600,000 IU as a single mega-dose. May be repeated after 3 to 6 months depending on serum 25(OH)D levels.
  • Maintenance: Once levels are normalized, transition to oral maintenance therapy or administer 300,000 IU IM once or twice a year.
  • Administration Note: Because it is an oily injection, it must be drawn up with a wide-bore needle and injected slowly, deep into the gluteal muscle. Injection site pain is common.

Safety Warnings (CRITICAL):

  • Hypercalcemia (Toxicity): Mega-doses can cause Vitamin D toxicity, leading to dangerous hypercalcemia (high blood calcium). Symptoms include nausea, weakness, polyuria, and kidney stones. Monitor serum calcium and 25(OH)D levels.
  • Contraindications: Do not use in patients with hypervitaminosis D, pre-existing hypercalcemia, or severe renal impairment with hyperphosphatemia.
  • Tissue Reactions: Oily injections can occasionally cause local inflammation or sterile abscesses at the injection site.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Sterile Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.

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