Description

Alfacalcidol Soft Gelatin Capsules

Healthy Inc is a specialized global supplier and exporter of advanced nephrology, endocrinology, and bone-metabolism therapeutics. We provide high-purity Alfacalcidol Soft Gelatin Capsules (0.25 mcg / 0.5 mcg / 1.0 mcg), manufactured in WHO–GMP certified, dedicated softgel facilities. This “Active Vitamin D3 Analogue” is a massive-volume, highly strategic export to nephrology centers, dialysis clinics, orthopedic hospitals, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the gold-standard intervention for renal osteodystrophy, secondary hyperparathyroidism, and severe hypocalcemia.

Product Overview

This formulation contains Alfacalcidol (1-alpha-hydroxycholecalciferol), a highly potent synthetic prodrug of calcitriol, the active form of Vitamin D.

The “Renal-Bypass” Bone Specialist:

• Mechanism (Hepatic Activation): Normal Vitamin D3 requires two activation steps: one in the liver, and a final, crucial step in the kidneys (via the 1-alpha-hydroxylase enzyme). Patients with Chronic Kidney Disease (CKD) lose this kidney enzyme, making standard Vitamin D supplements clinically useless. Alfacalcidol is already hydroxylated at the 1-alpha position. It completely bypasses the failing kidneys, requiring only a rapid pass through the liver to become fully active Calcitriol.
• Calcium & Phosphorus Homeostasis: Once activated, it massively increases the intestinal absorption of calcium and phosphorus, and promotes bone mineralization.
• Parathyroid Suppression: By aggressively correcting hypocalcemia, Alfacalcidol suppresses the over-secretion of Parathyroid Hormone (PTH), directly halting the severe bone destruction (renal osteodystrophy) that plagues dialysis patients.

Product Composition & Strength

We supply this product as a Liquid-Filled Soft Gelatin Capsule, packed in highly protective, opaque blister strips to prevent the extreme light-degradation associated with vitamin D analogues.

*Pack Sizes: 10×10 Opaque Alu-PVC Blisters or Alu-Alu Blisters. (Opaque packaging is an absolute necessity to maintain microgram API stability).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Nephrology Distributors.

Manufacturing Authority

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

• Microgram (mcg) Assay Precision: Because Alfacalcidol is dosed in fractions of a microgram, any manufacturing variance can cause lethal hypercalcemia or clinical failure. Our softgel facility utilizes advanced geometric liquid mixing and state-of-the-art HPLC validation to guarantee 100% homogenous API distribution across every single batch.
• Nitrogen-Purged Lipid Stabilization: To prevent the oxidative degradation of the delicate Alfacalcidol molecule, the lipid carrier matrix is heavily purged with nitrogen prior to encapsulation, ensuring full therapeutic potency over a 24-month shelf life.

Therapeutic Indications (Human Use)

Indicated for conditions where there is an impairment of 1-alpha-hydroxylation in the kidneys:

• Renal Osteodystrophy: Bone disease resulting from chronic kidney disease (CKD) and end-stage renal disease (ESRD) requiring dialysis.
• Secondary Hyperparathyroidism: Associated with moderate to severe chronic renal failure.
• Hypocalcemia: Specifically hypoparathyroidism, pseudo-hypoparathyroidism, and severe vitamin D-dependent rickets.
• Osteoporosis: Post-menopausal, senile, or steroid-induced osteoporosis (often prescribed alongside calcium supplements).

Dosage & Administration

Recommended Dosage (Strictly as per Nephrologist/Endocrinologist):

• Administration: Taken orally. Must not be chewed.
• Titration Protocol (CRITICAL): The dose must be highly individualized based on frequent monitoring of serum calcium, phosphorus, and PTH levels.
• Standard Adult Starting Dose: Typically 1.0 mcg per day for severe conditions, or 0.25 mcg to 0.5 mcg daily for maintenance/elderly patients.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Hypercalcemia Risk): Overdosing Alfacalcidol rapidly causes severe, potentially fatal hypercalcemia (abnormally high calcium in the blood). Symptoms include extreme thirst, polyuria, cardiac arrhythmias, and kidney stones. Serum calcium must be strictly monitored at least weekly during the titration phase.
• Digitalis Toxicity: Hypercalcemia drastically increases the risk of fatal cardiac arrhythmias in patients taking digitalis glycosides (e.g., Digoxin). Co-administration requires extreme caution and constant ECG monitoring.
• Phosphate Binding: In dialysis patients, hyperphosphatemia must be controlled with phosphate binders (like Sevelamer or Calcium Acetate) prior to and during Alfacalcidol therapy to prevent metastatic calcification in the soft tissues and blood vessels.

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 Nephrology and Bone-Metabolism Formulations, 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.