Duloxetine Enteric-Coated Capsules

Healthy Inc is a specialized global supplier and exporter of advanced psychiatric and neuropathic pain therapeutics. We provide high-purity Duloxetine Enteric-Coated Capsules (20 mg / 30 mg / 60 mg), manufactured in WHO–GMP certified advanced pelletization facilities. This “Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)” is a highly strategic, dual-purpose export to psychiatric hospitals, endocrinology clinics, pain management centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a frontline intervention for Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), and severe neuropathic pain syndromes.

Product Overview

This formulation contains Duloxetine (as Duloxetine Hydrochloride), a potent, dual-action reuptake inhibitor.

The “Neuro-Modulator” Specialist:

• Mechanism (SNRI Blockade): Duloxetine exerts its clinical effects by powerfully binding to and inhibiting both the Serotonin Transporter (SERT) and the Norepinephrine Transporter (NET) in the central nervous system. By preventing the reuptake of these two critical neurotransmitters, it elevates their concentrations in the synaptic cleft, which directly improves mood and decreases anxiety.
• Descending Pain Pathway Regulation: Unlike standard SSRIs (which only target serotonin), Duloxetine’s significant action on norepinephrine allows it to modulate the descending inhibitory pain pathways in the brain and spinal cord. This dual action “turns down the volume” on chronic pain signals, making it highly effective for centralized pain disorders.
• The Diabetic & Fibromyalgia Backbone: It is globally recognized as a gold-standard, non-opioid pharmacological treatment for Diabetic Peripheral Neuropathy (nerve damage from high blood sugar) and Fibromyalgia (widespread musculoskeletal pain).

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule containing Enteric-Coated (EC) Pellets, packed in moisture-resistant Alu-Alu blister strips.

*Pack Sizes: 10×10 Alu-Alu Blisters or 10×14 Alu-Alu Blisters (optimizing for psychiatric titration schedules).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority

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

• Acid-Labile Protection: Duloxetine is highly unstable in acidic environments and will rapidly degrade in the stomach if unprotected. Our advanced fluid-bed manufacturing process coats the active API onto spherical sugar cores, followed by a robust enteric polymer barrier. This ensures the drug completely bypasses the acidic stomach and dissolves only in the higher pH of the small intestine.
• Pellet Integrity: Formulated to ensure uniform gastric emptying of the pellets, preventing the sudden “dose dumping” that can trigger severe nausea—the most common reason patients abandon SNRI therapy.

Therapeutic Indications (Human Use)

Indicated for the management of psychiatric and chronic pain conditions:

• Major Depressive Disorder (MDD): Acute and maintenance treatment.
• Generalized Anxiety Disorder (GAD): Management of chronic, pervasive anxiety.
• Diabetic Peripheral Neuropathic Pain (DPNP): Management of neuropathic pain associated with diabetic neuropathy.
• Fibromyalgia: Management of widespread musculoskeletal pain and tenderness.
• Chronic Musculoskeletal Pain: Including chronic osteoarthritis pain and chronic lower back pain.

Dosage & Administration

Recommended Dosage (Strictly as per Psychiatrist/Neurologist):

• Administration: Taken orally once or twice daily, without regard to meals.
• MDD & GAD (Adults): Starting dose is typically 30 mg to 60 mg once daily. Target maintenance dose is 60 mg/day.
• DPNP & Fibromyalgia: Typically 60 mg once daily. (Initiating at 30 mg for the first week can help minimize early nausea).
• Swallowing Protocol (CRITICAL): The capsule MUST be swallowed whole. Do not chew or crush the capsule. Do not open the capsule and sprinkle the pellets on food, as this will destroy the enteric coating and render the drug ineffective.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Suicidality): Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (up to age 24). Close monitoring is mandatory.
• Hepatotoxicity (Liver Failure): Cases of severe hepatic failure, sometimes fatal, have been reported. Duloxetine is strictly contraindicated in patients with chronic liver disease, cirrhosis, or those who consume substantial amounts of alcohol.
• Severe Discontinuation Syndrome: Abrupt cessation can cause severe withdrawal symptoms (brain zaps, dizziness, intense nausea, irritability). The dose must be tapered gradually when stopping therapy.
• Serotonin Syndrome: Risk of potentially life-threatening serotonin syndrome when co-administered with other serotonergic agents (e.g., MAOIs, Triptans, Tramadol).

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 CNS and Neuropathic Pain Medicines, 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.