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Haloperidol Tablets product image

Haloperidol Tablets BP

Composition: Haloperidol BP 1.5 mg, 2 mg and 5 mg uncoated tablets; H PERIDOL-2 BP 2 mg.

Usage: Treatment of selected mental health and neurological disorders as prescribed.

Category: Antipsychotic / CNS Drugs

Therapeutic Category: First-generation antipsychotic

SKU: Haloperidol Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Haloperidol Tablets BP 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

Haloperidol Tablets

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Haloperidol is a first-generation butyrophenone antipsychotic prescribed for selected psychiatric and neurological conditions, including schizophrenia and certain tic disorders, in accordance with local approvals. Healthy Life Pharma Pvt. Ltd. is listed as the manufacturer and Healthy Inc as exporter.

The supplied formulations are BP 1.5 mg, 2 mg and 5 mg uncoated tablets. The 10 mg and 20 mg strengths mentioned in the draft are not confirmed by the supplied compositions.

2. Product Specifications

ProductComposition per tabletDosage form
Haloperidol Tablets BP 1.5 mgHaloperidol BP 1.5 mgUncoated
H PERIDOL-2Haloperidol BP 2 mgUncoated
Haloperidol Tablets BP 5 mgHaloperidol BP 5 mgUncoated
Haloperidol Tablets BP 5 mg (pantone excipient listing)Haloperidol BP 5 mg; excipients q.s.Uncoated

CAS: 52-86-8. Therapeutic category: Antipsychotic / CNS drugs. Pharmacopoeial reference: BP as provided. Packaging, appearance, shelf life, and market-specific registration status should be confirmed against the approved dossier.

3. Manufacturing Technology

Low-dose antipsychotic tablets require appropriate blending, content-uniformity controls, validated compression processes, and cross-contamination risk management. The exact use of geometric dilution, direct compression, dedicated manufacturing suites or specific containment equipment is product- and site-dependent and should be verified before making manufacturing claims.

4. Quality Assurance

Relevant testing may include identification, assay, uniformity of dosage units, dissolution, related substances and stability, using the applicable approved BP specification and validated analytical methods. Do not assume universal numerical limits without the product specification.

5. Pharmacology and Clinical Use

Haloperidol primarily blocks dopamine D2 receptors, reducing symptoms such as hallucinations and delusions in some patients. Its clinical role depends on diagnosis, age, comorbidities and regulatory labeling. Movement disorders, sedation, and cardiac effects are important treatment considerations.

6. Export and Regulatory Support

Export partners may enquire about certificates of analysis, registration dossiers, manufacturing documentation and logistics. CTD/ACTD dossiers, certificates and shipping arrangements must be verified for the relevant strength and importing country.

7. Frequently Asked Questions

Q: What strengths are confirmed?
A: BP 1.5 mg, 2 mg (H PERIDOL-2) and 5 mg uncoated tablets.

Q: Is this automatically bioequivalent to Haldol?
A: A shared active ingredient does not establish bioequivalence; product-specific regulatory evidence is needed.

Q: Can it cause muscle spasms or abnormal movements?
A: Yes. Acute dystonia, akathisia, parkinsonism and tardive dyskinesia are recognized adverse effects. Seek prompt medical assessment for severe symptoms.

Q: Is it approved for dementia-related psychosis?
A: Antipsychotics are associated with increased mortality in older adults with dementia-related psychosis; use requires special caution and local-label review.

8. Dosage and Administration

Dose, frequency and duration must be individualized by a qualified prescriber. The appropriate dose varies widely by indication, patient age, response, concomitant medicines and adverse-effect risk. Do not stop or change treatment abruptly without professional guidance.

9. Side Effects and Precautions

  • Movement disorders: acute dystonia, parkinsonism, akathisia and potentially persistent tardive dyskinesia.
  • Neuroleptic malignant syndrome: fever, marked muscle rigidity and confusion require emergency care.
  • Cardiac risk: QT prolongation and serious arrhythmias; consider risk factors, interacting medicines and ECG monitoring as clinically indicated.
  • Older adults with dementia-related psychosis: increased mortality risk.
  • Other: sedation, falls, orthostatic symptoms, endocrine effects and interactions. Pregnancy and breastfeeding require specialist assessment.

10. Storage Instructions

Store according to the approved package labeling, protected from excessive heat, moisture and light where indicated. Keep out of reach of children.