Product Information
Duloxetine Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Description
Duloxetine Tablets (20mg / 30mg / 40mg / 60mg)
Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)
1. Product Introduction
Healthy Life Pharma Pvt. Ltd. is a manufacturer of Duloxetine delayed-release formulations in India. Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) used for major depressive disorder and generalized anxiety disorder. Depending on the country's approved labeling, Duloxetine may also be indicated for selected chronic pain conditions such as diabetic peripheral neuropathic pain, fibromyalgia or chronic musculoskeletal pain.
Duloxetine is acid-sensitive, so delayed-release dosage forms are designed to limit release in the acidic stomach and release the medicine later in the gastrointestinal tract. The exact dosage form, enteric-coating system, strengths and approved indications must follow the registered product.
2. Product Specifications
| Parameter | Specification |
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| Product Name | Duloxetine Delayed-Release Tablets |
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| Generic Name | Duloxetine Hydrochloride delayed-release formulation |
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| CAS Number | 136434-34-9 (Duloxetine Hydrochloride) |
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| Primary Composition | Duloxetine Hydrochloride equivalent to Duloxetine 20mg per enteric-coated tablet |
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| Other Strengths | 30mg / 40mg / 60mg where separately developed and registered |
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| Dosage Form | Enteric-coated / delayed-release tablet according to registered formulation |
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| Standard | Applicable pharmacopoeial / registered specification |
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| Therapeutic Class | SNRI Antidepressant |
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| Shelf Life | 24–36 months where supported by validated stability data |
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| Packaging | Alu-Alu blister / bottle or market-specific registered pack |
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3. Manufacturing Technology
- Delayed-Release Protection: A validated enteric-coating system may be used to protect acid-sensitive Duloxetine from gastric conditions and permit release at a higher gastrointestinal pH. Polymer type, coating weight and target pH are product-specific.
- Dosage-Form Control: Tablets and pellet-filled capsules use different technologies and should not be described as automatically interchangeable or as having universally different stability.
- Coating Process: Spray rate, temperature, atomization and drying are controlled to obtain a uniform functional coat and minimize defects such as sticking or twinning.
- Moisture Control: Manufacturing and packaging controls are selected using product-specific stability data.
4. Quality Assurance
- Dissolution / Delayed Release: Acid resistance and subsequent release are tested using the registered multi-stage dissolution method and acceptance criteria. Universal values such as <10% release in acid and >85% in buffer should not be claimed unless they are the approved specification for the exact product.
- Assay & Uniformity: Potency and dosage-unit uniformity are tested using validated methods.
- Related Substances: Duloxetine degradation products and other relevant impurities are controlled according to the registered specification.
- Stability: Shelf life and packaging are supported by validated stability studies.
5. Pharmacology and Clinical Use
Duloxetine inhibits neuronal reuptake of serotonin and norepinephrine. Its approved uses vary by market and should be stated according to the local prescribing information.
- Major Depressive Disorder: Used for treatment according to approved labeling.
- Generalized Anxiety Disorder: Used for treatment according to approved labeling.
- Neuropathic / Chronic Pain: Certain pain indications may be approved in some markets, including diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain.
6. Export and Regulatory Support
- Dossier Support: CTD / ACTD documentation where available for the specific registered product.
- Bioequivalence: Bioequivalence data should only be represented as available when a product-specific study or accepted regulatory basis exists.
- Certificates: FSC, COPP and COA where applicable.
- Logistics: Air or sea shipment via FOB Mumbai / CIF according to applicable requirements.
7. Frequently Asked Questions
Q: Who manufactures Duloxetine Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Duloxetine formulations in India.
Q: Is this the same as Cymbalta?
A: Cymbalta is a brand of Duloxetine. A product should only be described as therapeutically equivalent or bioequivalent to a specific reference product when the required regulatory evidence supports that claim.
Q: Can I crush the tablet?
A: Delayed-release/enteric-coated dosage forms generally should not be crushed or chewed because this can damage the release-controlling system. Follow the exact product label.
Q: Can Duloxetine cause sexual side effects?
A: Sexual dysfunction, including reduced libido and difficulties with orgasm or ejaculation, can occur. Patients with troublesome effects should discuss them with their prescriber rather than stopping treatment abruptly.
Clinical Pharmacology & Safety Information
(For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
- Individualized Dosing: Starting dose, target dose, titration and maximum dose depend on indication, age, comorbidities, tolerability and the registered prescribing information; a universal fixed schedule should not be applied.
- Administration: Delayed-release tablets should generally be swallowed intact according to the exact label. Food instructions can vary by formulation.
- Discontinuation: Abrupt discontinuation can produce symptoms such as dizziness, sensory disturbances, sleep disturbance, anxiety, headache or nausea. Dose reduction should follow prescriber guidance and the product label.
9. Side Effects and Precautions
- Common Effects: Nausea, dry mouth, constipation, dizziness, sleepiness or insomnia, sweating and reduced appetite can occur.
- Suicidality Warning: Antidepressants carry important warnings about increased suicidal thoughts and behaviors in some children, adolescents and young adults, particularly early in treatment or around dose changes. Monitor according to prescribing guidance.
- Serotonin Syndrome: Risk increases with other serotonergic medicines. Symptoms can be serious and require urgent medical attention.
- Liver: Duloxetine can cause liver injury. Avoidance or special caution may be required in substantial alcohol use or chronic liver disease according to local prescribing information.
- Blood Pressure: Duloxetine can increase blood pressure or heart rate in some patients; monitoring may be appropriate.
- Other Precautions: Consider bleeding risk with NSAIDs/antiplatelets/anticoagulants, hyponatremia, angle-closure glaucoma risk, urinary hesitation/retention and relevant drug interactions, including MAO inhibitors.
10. Storage Instructions
- Store below 25°C unless otherwise specified on the registered label.
- Protect from excessive heat and moisture.
- Keep in original packaging and out of reach of children.
