Description
Fluphenazine Decanoate Injection
Healthy Inc is a specialized global supplier and exporter of long-acting depot antipsychotics. We provide high-purity Fluphenazine Decanoate Injection (25 mg / 1 ml), sourced from WHO–GMP certified sterile injectable facilities. This “Schizophrenia Anchor” is a top export to psychiatric institutions, mental health clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the cornerstone maintenance therapy for chronic schizophrenia and patients with poor oral medication compliance.
Product Overview
This formulation contains Fluphenazine Decanoate, a long-acting ester of the potent phenothiazine antipsychotic fluphenazine.
The “Depot” Specialist:
- Mechanism (Dopamine Blockade): Fluphenazine is a potent antagonist at Dopamine D2 receptors in the mesolimbic pathway of the brain. By blocking excessive dopamine activity, it reduces the “positive symptoms” of schizophrenia (hallucinations, delusions, and disorganized thinking).
- Depot Technology (The “Time-Release”): The active drug is esterified with decanoic acid and dissolved in sesame oil. After intramuscular injection, enzymes in the body slowly hydrolyze the ester, releasing the active fluphenazine into the bloodstream over a period of 2 to 4 weeks. This ensures stable blood levels without daily pills.
- Compliance Solution: It is specifically designed for patients who frequently forget or refuse to take oral medication (“non-compliant”), preventing relapse and re-hospitalization.
Product Composition & Strength
We supply this product as a Sterile Oily Solution in Amber Glass Ampoules or Vials.
| Active Ingredient | Strength | Type |
|---|---|---|
| Fluphenazine Decanoate USP/BP | 25 mg | 1 ml Ampoule / Vial |
| Fluphenazine Decanoate USP/BP | 12.5 mg | 0.5 ml Ampoule (Starter Dose) |
| Vehicle | Sesame Oil | Depot Base |
| Preservative | Benzyl Alcohol | 1.5% v/v (In Vials) |
*Pack Sizes: Tray of 5 Ampoules, 10 Ampoules, or 10 ml Multi-Dose Vial.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| Dosage Form | Injection (Oily Depot Solution) |
| Packaging | Amber Type I Glass Ampoule/Vial (Light Sensitive) |
| 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.
- Viscosity Control: The release rate of Fluphenazine Decanoate is heavily dependent on the viscosity of the oil vehicle. We use pharmaceutical-grade refined Sesame Oil with strict viscosity specifications to guarantee the drug releases consistently over the 3-4 week period, preventing “dumping” (overdose) or “tailing off” (relapse).
- Oxidation Protection: Phenothiazines turn pink or brown if oxidized. We process under nitrogen to ensure the solution remains clear and pale yellow.
Therapeutic Indications (Human Use)
Indicated for the long-term management of:
- Schizophrenia: Chronic maintenance therapy.
- Paranoid Disorders: Long-term management of delusional disorders.
- Note: Not for acute stabilization (onset is too slow). Use oral or short-acting injection first.
Dosage & Administration
Recommended Dosage (Strictly as per Psychiatrist):
- Route: Deep Intramuscular (IM) Injection ONLY. (Gluteal or Deltoid).
- Initial Dose: 12.5 mg to 25 mg (0.5 to 1 ml).
- Maintenance Dose: 12.5 mg to 100 mg administered every 2 to 5 weeks.
- Adjustment: Dosage and interval are individualized based on patient response.
- Technique: Use a dry needle and syringe (water causes the oil to become cloudy). Inject slowly (“Z-track” technique recommended to prevent leakage).
Safety Warnings (CRITICAL):
- Extrapyramidal Symptoms (EPS): High risk of Parkinson-like tremors, rigidity, and dystonia. Patients often require co-prescription of anticholinergics (like Trihexyphenidyl/Benzhexol).
- Tardive Dyskinesia: Long-term use can cause irreversible involuntary movements of the face/tongue. Monitor regularly.
- Neuroleptic Malignant Syndrome (NMS): Rare but fatal fever and rigidity. Stop immediately if suspected.
- Not for IV Use: ABSOLUTE CONTRAINDICATION. Injecting oil into a vein causes pulmonary oil embolism.
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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