Betamethasone Injection

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Description

Betamethasone Sodium Phosphate Injection

Healthy Inc is a specialized global supplier and exporter of high-potency corticosteroids. We provide high-purity Betamethasone Sodium Phosphate Injection (4mg/ml), sourced from WHO–GMP certified sterile injectable facilities. This “Steroid of Choice” is a top export to neonatal units (NICU), allergy clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the gold standard for inducing fetal lung maturity and managing severe allergic reactions.


Product Overview

This formulation contains Betamethasone Sodium Phosphate, a potent synthetic glucocorticoid with negligible mineralocorticoid (salt-retaining) activity.

The “Potent & Pure” Specialist:

  • Potency: Betamethasone is approximately 25 to 30 times more potent than Hydrocortisone and 5-6 times more potent than Prednisolone. This allows for small-volume injections to achieve powerful anti-inflammatory effects.
  • Zero Sodium Retention: Unlike Hydrocortisone, it lacks mineralocorticoid activity, making it ideal for patients with heart failure or hypertension as it does not cause fluid retention or edema.
  • Fetal Lung Maturity (Gold Standard): It crosses the placental barrier efficiently and stimulates the production of Surfactant in the lungs of a preterm fetus, significantly reducing the risk of Respiratory Distress Syndrome (RDS) and neonatal mortality.

Product Composition & Strength

We supply this product as a Sterile Solution in Clear Glass Ampoules. The phosphate ester ensures high water solubility and rapid onset of action.

Active Ingredient Strength (Standard) Therapeutic Role
Betamethasone Sodium Phosphate USP/BP Equivalent to 4 mg Betamethasone Potent Anti-inflammatory
Excipients Q.S. Disodium Edetate / Sodium Metabisulfite Stabilizer / Antioxidant

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


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

HS Code 3004.32.00 (Medicaments containing corticosteroids)
Dosage Form Injection (Liquid in Ampoule)
Packaging Clear Type I Glass Ampoule (Sterile)
Storage Store below 25°C. Protect from Light. Do not freeze.
Certificates WHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

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

  • Sterile Filtration: We use double-filtration (0.22 micron) technology to ensure the solution is free from particulate matter, which is critical for intravenous administration in emergency settings.
  • Oxidation Control: Betamethasone is sensitive to oxidation. Our filling lines utilize Nitrogen purging to displace oxygen, and we include stabilized antioxidants to prevent discoloration (browning) of the solution.

Therapeutic Indications (Human Use)

Indicated for the treatment of severe inflammatory and allergic conditions:

  • Antenatal Use (Preterm Labor): Given to mothers at risk of preterm delivery (24-34 weeks) to accelerate fetal lung maturation.
  • Severe Allergic Reactions: Anaphylaxis (as an adjunct to Adrenaline), Status Asthmaticus, and severe drug reactions.
  • Autoimmune Disorders: Acute exacerbations of Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis.
  • Dermatology: Severe acute dermatoses (Stevens-Johnson Syndrome).

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

  • Route: Intravenous (IV) Injection or Deep Intramuscular (IM) Injection.
  • Antenatal (Lung Maturity): 12 mg (3 ampoules) IM every 24 hours for 2 doses.
  • Adults (Systemic): 4 mg to 20 mg daily via IV/IM, depending on severity.
  • Local Injection: Can be injected intra-articularly (into joints) for Rheumatoid Arthritis.

Safety Warnings (CRITICAL):

  • Infection Masking: Corticosteroids suppress the immune system and can mask signs of infection. Do not use in systemic fungal infections.
  • Hyperglycemia: Will spike blood sugar levels. Diabetic patients require strict monitoring and insulin dosage adjustment.
  • Adrenal Suppression: Long-term use causes adrenal atrophy. Do not stop abruptly; taper the dose.

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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