Description

Sertraline Tablets (25mg – 100mg)

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 specialized Manufacturer of Sertraline Tablets in India. Sertraline is a premier Selective Serotonin Reuptake Inhibitor (SSRI) antidepressant, widely prescribed for the treatment of Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Panic Disorder, and Post-Traumatic Stress Disorder (PTSD).

We offer Contract Manufacturing (Third Party) services for this high-volume CNS medication. As one of the most tolerated SSRIs with a favorable safety profile, it is a staple in psychiatric care globally. Our WHO-GMP certified facility in Mumbai utilizes high-speed tableting lines with automated weight control systems to ensure precise dosing, which is critical for titration. Healthy Inc manages the export logistics, supplying mental health institutions and pharmacy chains across the USA, Europe, Latin America, and Australia.

2. Product Specifications

3. Manufacturing Technology

Consistency and stability are the pillars of our production.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Content Uniformity: Sertraline requires careful titration (starting low and going slow). We use High-Shear Granulation to ensure that the active ingredient is homogeneously distributed in the tablet matrix, ensuring that a half-tablet (scored) delivers exactly half the dose.

  • Polymorph Stability: Sertraline HCl exists in multiple crystalline forms. We strictly control the manufacturing process parameters (temperature and solvent use) to ensure the API remains in its most stable and bioavailable polymorphic form (Form I or II).

  • Film Coating: We use Opadry II coating systems to facilitate swallowing and provide a distinct color for dosage differentiation (e.g., 50mg Blue, 100mg Yellow).

• The Exporter: Healthy Inc

  • Calendar Packs: For export markets (especially EU/UK), we offer Calendar Blister Packs (marked Mon-Sun) to assist patients with adherence to their daily regimen.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes, guaranteeing consistent absorption.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We strictly monitor for degradation products and residual solvents to ensure safety over the 3-year shelf life.

5. Why Use Sertraline?

It is often the “First-Line” choice for anxiety and depression.

• Mechanism: It blocks the reabsorption (reuptake) of serotonin in the brain. This increases the levels of available serotonin, a neurotransmitter that helps regulate mood, sleep, and appetite.

• Key Indications:

  • Depression: Major Depressive Disorder (MDD).

  • Anxiety: Panic Disorder, Social Anxiety Disorder, and Generalized Anxiety.

  • OCD: Obsessive-Compulsive Disorder (Approved for adults and children 6+).

  • PTSD: Post-Traumatic Stress Disorder.

  • PMDD: Premenstrual Dysphoric Disorder.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Sertraline Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it addictive?

  A: No. SSRIs like Sertraline are not addictive like benzodiazepines. However, stopping them abruptly can cause “discontinuation syndrome” (flu-like symptoms, dizziness).

• Q: How long does it take to work?

  A: It typically takes 2 to 4 weeks to notice an improvement in sleep and appetite, and 6 to 8 weeks for full mood improvement.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Starting Dose: Often 50mg once daily (25mg for Panic Disorder/PTSD).

• Max Dose: 200mg per day.

• Administration: Swallow whole. Can be taken with or without food, but should be taken at the same time each day (morning or evening).

9. Side Effects and Precautions

• Common Side Effects: Nausea, diarrhea (loose stools), insomnia, dry mouth, and sexual dysfunction (delayed ejaculation/low libido).

• Suicidality Warning: Black Box Warning: Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. Monitor closely.

• Serotonin Syndrome: Risk increases if combined with other serotonergic drugs (MAOIs, Tramadol, St. John’s Wort).

• Bleeding: May increase risk of bleeding events, especially if used with NSAIDs/Aspirin.

10. Storage Instructions

• Store below 30°C in a dry place.

• Keep out of reach of children.