Description

Haloperidol Tablets (1.5mg / 5mg / 10mg / 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 Haloperidol Tablets in India. Haloperidol is a high-potency First-Generation (Typical) Antipsychotic belonging to the butyrophenone class. It is a cornerstone therapy for the management of Schizophrenia, acute Manic Episodes in Bipolar Disorder, and for controlling tics and vocal utterances in Tourette’s Syndrome.

We offer Contract Manufacturing (Third Party) services for this potent psychotropic agent. Unlike low-potency antipsychotics (like Chlorpromazine), Haloperidol is effective at very low doses (milligrams) but carries a higher risk of movement disorders. Our WHO-GMP certified facility in Mumbai utilizes high-containment manufacturing suites to handle potent compounds safely, ensuring zero cross-contamination. Healthy Inc manages the export logistics, supplying psychiatric hospitals and government mental health programs across Africa, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Precision dosing for potent neuroleptics.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Content Uniformity: Since Haloperidol is a high-potency drug (active at 1.5mg), slight variations in mixing can lead to significant side effects or lack of efficacy. We use Geometric Dilution blending protocols to ensuring a homogenous mix where every tablet contains exactly the labeled dose.

  • Containment: The drug is a potent CNS depressant. We manufacture it in Dedicated Suites with independent air handling units (AHUs) to protect our staff and prevent cross-contamination with other products.

  • Direct Compression: We utilize specialized excipients that allow for direct compression, avoiding wet granulation which can sometimes degrade sensitive APIs through heat.

• The Exporter: Healthy Inc

  • Institutional Packs: We specialize in bulk packaging (1000s jars) for long-term care facilities and mental health institutions where daily dispensing is managed by nurses.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

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

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

• Impurity Profiling: We strictly monitor for the “dehydrated” impurity (Haloperidol pyridinium metabolite) to ensure safety.

5. Why Use Haloperidol?

It quiets the “voices” by blocking dopamine.

• Mechanism: Haloperidol is a strong Dopamine D2 Receptor Antagonist. By blocking dopamine receptors in the mesolimbic pathway of the brain, it effectively reduces the “positive symptoms” of schizophrenia (hallucinations, delusions, and disorganized thinking).

• Key Indications:

  • Schizophrenia: Acute and maintenance treatment.

  • Tourette’s Syndrome: Controls motor tics and verbal outbursts.

  • Acute Agitation: Used in emergency settings to calm violent or aggressive behavior (often with Lorazepam).

  • Severe Behavioral Problems: In children with combative, explosive hyperexcitability.

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 Haloperidol Tablets?

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

• Q: Is it Haldol?

  A: Haldol is the brand name (Janssen). We manufacture the Generic Equivalent (Haloperidol), which is bioequivalent.

• Q: Does it cause “Lockjaw”?

  A: Yes. It can cause Acute Dystonia (muscle spasms, locked jaw, stiff neck). This is a known side effect called EPS. It can be treated immediately with Diphenhydramine or Benztropine.

• Q: Is it safe for dementia patients?

  A: NO. It carries a Black Box Warning for increased risk of death in elderly patients with dementia-related psychosis. It should generally be avoided in this population.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Schizophrenia (Adults): 0.5mg to 5mg, two or three times daily. Max 100mg/day (rarely needed).

• Tourette’s: 0.5mg to 2mg daily.

• Administration: Swallow whole with water. Can be taken with food to reduce GI upset.

9. Side Effects and Precautions

• EPS (Extrapyramidal Symptoms): Parkinsonism (tremors, rigidity), Akathisia (restlessness), and Dystonia.

• Tardive Dyskinesia: Involuntary movements of the face/tongue (lip smacking) after long-term use. Can be permanent.

• NMS (Neuroleptic Malignant Syndrome): Rare but fatal reaction (high fever, muscle rigidity). Stop drug immediately.

• QT Prolongation: Can cause heart rhythm issues (Torsades de Pointes). Monitor ECG.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.