Description

Olanzapine Tablets (2.5mg – 20mg)

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 Olanzapine Tablets in India. Olanzapine is a premier Atypical Antipsychotic (Second Generation) widely prescribed for the management of Schizophrenia and Bipolar I Disorder (Manic or Mixed Episodes). It is known for its broad efficacy in treating both positive symptoms (hallucinations) and negative symptoms (withdrawal/apathy).

We offer Contract Manufacturing (Third Party) services for this high-volume CNS medication. Olanzapine is moisture-sensitive (hygroscopic) and susceptible to oxidation (turning yellow). Our WHO-GMP certified facility in Mumbai utilizes specialized low-humidity processing suites and protective coating technologies to ensure product stability. We also manufacture Mouth Dissolving (MD) variants, which are crucial for psychiatric patients who may be “cheek” (hiding) pills or need rapid sedation. Healthy Inc manages the export logistics, supplying mental health institutions and pharmacy chains across the USA, Europe, the Middle East, and Australia.

2. Product Specifications

3. Manufacturing Technology

Stability and patient compliance are the drivers.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Moisture Protection: Olanzapine is hygroscopic (absorbs water) and exists in different crystal forms. We manufacture in Dehumidified Suites (< 25% RH) to prevent the tablet from absorbing moisture, which can cause chemical instability and discoloration.

  • Mouth Dissolving (MD): For non-compliant patients, we offer ODT (Orally Disintegrating Tablets). These are made using a specialized matrix that dissolves on the tongue in < 30 seconds without water, ensuring the medication is actually swallowed.

  • Oxidation Control: The drug turns yellow if oxidized. We use opaque Film Coatings and inert excipients to protect the core from air and light.

• The Exporter: Healthy Inc

  • Alu-Alu Packaging: We exclusively recommend Alu-Alu Cold Form Blisters for this product. This provides a hermetic seal against moisture and light, which is non-negotiable for Olanzapine’s shelf-life in export markets.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution:

  • Standard Tabs: >80% release in 30 minutes.

  • MD Tabs: Disintegration in < 30 seconds.

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

• Related Substances: We strictly monitor for degradation products (lactams) to ensure safety.

5. Why Use Olanzapine?

It is a powerful stabilizer for severe mental illness.

• Mechanism: It blocks receptors for Dopamine (D2) and Serotonin (5-HT2A). This dual action helps normalize brain activity, reducing hallucinations while also lifting mood and improving social functioning.

• Key Indications:

  • Schizophrenia: Acute treatment and maintenance to prevent relapse.

  • Bipolar Disorder: Treatment of acute manic or mixed episodes.

  • Depression: (In combination with Fluoxetine) Treatment of Treatment-Resistant Depression.

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 Olanzapine Tablets?

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

• Q: Does it cause weight gain?

  A: Yes. Olanzapine is known to cause significant weight gain and metabolic changes (increased blood sugar/cholesterol). Diet and exercise monitoring is essential.

• Q: Does it make you sleepy?

  A: Yes. Sedation is a very common side effect, especially when starting treatment. It is usually taken at bedtime.

• Q: Is the MD tablet better?

  A: It is “better” for patients who have trouble swallowing or who might try to spit out the medicine. The clinical effect is the same.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Schizophrenia: Start 5-10mg once daily. Target dose 10mg/day.

• Bipolar Mania: Start 10-15mg once daily.

• Administration: Swallow whole (standard tablet) or place on tongue (MD tablet). Can be taken with or without food.

9. Side Effects and Precautions

• Metabolic Syndrome: High risk of weight gain, hyperglycemia (diabetes), and dyslipidemia (high cholesterol). Regular blood tests (glucose/lipids) are mandatory.

• Sedation: Somnolence and dizziness.

• EPS: Low risk of movement disorders compared to older antipsychotics, but still possible.

• Elderly: Black Box Warning: Increased risk of death in elderly patients with dementia-related psychosis.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture. (Keep in Alu-Alu blister until use).