Description

Risperidone Tablets (1mg – 4mg)

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 Risperidone Tablets in India. Risperidone is a widely prescribed Atypical Antipsychotic (Second Generation) used for the treatment of Schizophrenia, Bipolar Mania, and irritability associated with Autistic Disorder. Unlike older antipsychotics, Risperidone has a lower risk of extrapyramidal side effects (movement disorders) at therapeutic doses and is effective against both “positive” (hallucinations) and “negative” (withdrawal) symptoms of psychosis.

We offer Contract Manufacturing (Third Party) services for this high-volume CNS medication. Risperidone is a potent drug active in very small doses. Our WHO-GMP certified facility in Mumbai utilizes high-precision granulation and compression equipment to ensure content uniformity, which is critical for patient safety. Healthy Inc manages the export logistics, supplying psychiatric hospitals and government tenders across the Middle East, Africa, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Ensuring dose accuracy is our manufacturing priority.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Content Uniformity: Since the dosage is low (e.g., 1mg), ensuring the active ingredient is perfectly distributed in the tablet is vital. We use Geometric Mixing and High-Shear Granulation to prevent segregation of the API from the excipients.

  • Micronization: Risperidone is practically insoluble in water. We use Micronized API to increase surface area, ensuring consistent dissolution and bioavailability.

  • Film Coating: We use color-coded Opadry Film Coatings to help patients and caregivers easily distinguish between different strengths (e.g., 2mg is often peach/orange, 4mg is green/yellow), reducing medication errors.

• The Exporter: Healthy Inc

  • Child-Resistant Packaging: Upon request, we can provide Child-Resistant Blisters (peel-push) or HDPE bottles to prevent accidental ingestion by children, which is a major safety concern for potent antipsychotics.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 45 minutes in 0.1N HCl.

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

• Related Substances: We strictly monitor for degradation products (like N-oxide derivatives) to ensure safety over the 3-year shelf life.

5. Why Use Risperidone?

It is a versatile first-line treatment for psychosis.

• Mechanism: It blocks Dopamine Type 2 (D2) receptors and Serotonin Type 2 (5-HT2) receptors in the brain. Blocking dopamine reduces hallucinations and delusions, while blocking serotonin helps improve mood and reduce negative symptoms.

• Key Indications:

  • Schizophrenia: Acute and maintenance treatment.

  • Bipolar Mania: Treatment of acute manic or mixed episodes (often with Lithium or Valproate).

  • Autism: Treatment of irritability (aggression, self-injury, temper tantrums) in children and adolescents.

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 Risperidone Tablets?

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

• Q: Does it cause weight gain?

  A: Yes. Weight gain is a common side effect of atypical antipsychotics. Patients should monitor their diet and exercise.

• Q: Is it safe for elderly patients with dementia?

  A: NO. Black Box Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death (mostly cardiovascular or infectious). It is generally avoided in this population.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Schizophrenia: Initial 2mg/day. Can be increased to 4-8mg/day.

• Bipolar Mania: Initial 2-3mg once daily.

• Autism (Children): Weight-based dosing (usually starting at 0.25mg or 0.5mg).

• Administration: Swallow whole. Can be taken with or without food.

9. Side Effects and Precautions

• Hyperprolactinemia: Risperidone raises prolactin levels more than other atypicals. This can cause breast enlargement (gynecomastia) and milk production (galactorrhea) in both men and women.

• EPS: At high doses (>6mg), risk of tremors and stiffness increases.

• Metabolic: Risk of hyperglycemia (high blood sugar) and dyslipidemia.

• Sedation: Drowsiness is common; avoid driving until effects are known.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.