Description
Duloxetine Gastro-Resistant Tablets / Capsules
Healthy Inc is a specialized global supplier and exporter of advanced dual-action CNS agents. We provide high-purity Duloxetine Delayed-Release (Gastro-Resistant) Tablets & Capsules, sourced from WHO–GMP certified solid dosage facilities. This “Dual-Inhibitor” is a top export to pain management clinics, psychiatric institutions, and rheumatology centers in Africa, LATAM, and Southeast Asia, recognized as the premier solution for treating both the emotional symptoms of depression and the physical burden of chronic pain.
Product Overview
This formulation contains Duloxetine Hydrochloride, a potent Serotonin-Norepinephrine Reuptake Inhibitor (SNRI).
The “Mood & Body” Specialist:
- Dual Mechanism: Duloxetine inhibits the reuptake of both Serotonin (regulating mood/anxiety) and Norepinephrine (regulating energy/pain signals) in the brain and spinal cord.
- Pain Inhibition: Unlike SSRIs (like Fluoxetine), Duloxetine specifically activates the descending pain inhibitory pathways in the spinal cord. This makes it highly effective for Neuropathic Pain (nerve pain) and chronic musculoskeletal pain.
- Broad Spectrum: It is one of the few drugs approved for Major Depressive Disorder, Generalized Anxiety Disorder, Diabetic Peripheral Neuropathy, and Fibromyalgia.
- Acid Labile Protection: The API is rapidly destroyed by stomach acid. Our formulation uses advanced enteric coating (Gastro-Resistant technology) to ensure the drug passes through the stomach intact and releases only in the small intestine for absorption.
Product Composition & Strength
We supply this product as Gastro-Resistant Tablets or Delayed-Release Capsules (containing enteric-coated pellets). Both forms ensure optimal bioavailability.
| Active Ingredient | Strength (Standard) | Primary Role |
|---|---|---|
| Duloxetine HCl USP/BP | 20 mg | Geriatric / Initial Dose |
| Duloxetine HCl USP/BP | 30 mg | Standard Maintenance (Pain/Anxiety) |
| Duloxetine HCl USP/BP | 40 mg | High Strength (Specific Mkts) |
| Duloxetine HCl USP/BP | 60 mg | High Strength (Depression/Neuropathy) |
*Pack Sizes: Alu-Alu Blister packs of 10s (Box of 10×10), 14s, 28s, or Bulk HDPE Jars of 500s.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Gastro-Resistant Tablet or Capsule |
| Packaging | Alu-Alu Blister (Strict Moisture Control) |
| Storage | Store below 25°C. Protect from Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Pelletization Technology: For our capsule variant, we use multi-layer coating technology on sugar spheres. The barrier coat prevents interaction between the drug and the enteric coat, while the outer enteric coat ensures pH-dependent release (> pH 5.5).
- Hydrolysis Prevention: Duloxetine hydrolyzes to toxic naphthol if exposed to moisture. We manufacture in low-humidity suites (< 30% RH) and use cold-form Alu-Alu packaging to guarantee shelf-life stability.
Therapeutic Indications (Human Use)
Indicated for the management of chronic pain and mood disorders:
- Major Depressive Disorder (MDD): Acute and maintenance treatment.
- Generalized Anxiety Disorder (GAD): For chronic anxiety.
- Diabetic Peripheral Neuropathy: Management of burning/shooting nerve pain associated with diabetes.
- Fibromyalgia: Management of widespread musculoskeletal pain.
- Chronic Musculoskeletal Pain: Osteoarthritis and chronic lower back pain.
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Route: Oral.
- Depression/Diabetic Pain: 60 mg once daily. (Can start at 30 mg for 1 week to improve tolerance).
- Fibromyalgia: 30 mg once daily for 1 week, then increased to 60 mg once daily.
- Administration: Swallow whole. Do not chew, crush, or open the tablet/capsule, as this destroys the enteric coating and leads to drug destruction in the stomach.
Safety Warnings:
- Hepatotoxicity: Can cause liver damage. Contraindicated in patients with pre-existing liver disease or heavy alcohol use. Monitor liver enzymes.
- Withdrawal Syndrome: Abrupt discontinuation can cause “brain zaps,” dizziness, and nausea. Taper dose slowly over weeks.
- Suicidality: Monitor young adults for worsening depression or suicidal thoughts during initial treatment.
- Hypertension: Can slightly raise blood pressure (due to norepinephrine effect).
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 OSD (Oral Solid Dosage) forms, 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.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
