Praziquantel Tablets USP – Manufacturer & Exporter India

1. Product Introduction

Praziquantel is an anthelmintic medicine used against certain trematode (fluke) and cestode (tapeworm) infections. It is widely used in schistosomiasis control programs and in treatment of other susceptible parasitic infections. Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as the exporter in the supplied product information. Actual manufacturing certifications and export capabilities should be confirmed with current records.

2. Product Specifications

3. Manufacturing Technology

Praziquantel's bitterness and formulation characteristics make palatability, dissolution and tablet uniformity important development considerations. Appropriate film-coating, excipient selection, process controls and moisture-protective packaging may be evaluated based on validated formulation data. A quadrisected design, micronized API, specific coating process or proprietary manufacturing equipment should not be assumed without documentation.

4. Quality Assurance

Relevant quality checks may include identity, assay, uniformity of dosage units, dissolution, related substances, microbial quality where applicable, and stability testing. Acceptance criteria and sampling plans must follow the applicable approved USP monograph, registered specification and validated analytical procedures; no universal numeric dissolution or assay limit is asserted here.

5. Mechanism and Therapeutic Uses

Praziquantel alters calcium homeostasis in susceptible parasitic worms, causing muscle contraction and paralysis and contributing to parasite clearance. Indications depend on the organism and local authorization.

• Schistosomiasis: Used for susceptible Schistosoma infections.
• Liver flukes: May be used for clonorchiasis and opisthorchiasis under applicable treatment guidance.
• Tapeworm infections: Used for certain intestinal cestode infections; management differs by species.
• Neurocysticercosis: Requires specialist assessment and a specific regimen, with attention to inflammatory complications; not equivalent to routine intestinal tapeworm treatment.

6. Export and Regulatory Support

For distributor, tender or registration enquiries, request the current product registration status, applicable manufacturing licenses, approved specifications, stability documentation, batch certificates and export documents. Availability of CTD/ACTD dossiers, COPP, Free Sale Certificate, WHO-GMP evidence, specific packaging and shipment terms must be verified for the destination market before commitments are made.

7. Frequently Asked Questions

Who is listed as the manufacturer?

Healthy Life Pharma Pvt. Ltd. is identified as manufacturer in the supplied information, with Healthy Inc as exporter.

Is the 600 mg tablet divided into four equal doses?

Not necessarily. Scoring and dose-splitting accuracy must be confirmed for the actual approved product. Only divide a tablet when the label or prescriber permits it.

Can tablets be chewed?

Praziquantel tastes very bitter. Follow the approved instructions for swallowing and any permitted splitting; avoid chewing unless specifically instructed.

Is it suitable during pregnancy?

Treatment decisions depend on the infection, gestational stage, local guidance and clinician assessment. Patients should not self-prescribe.

8. Dosage and Administration

Praziquantel dosing is based on the parasite, body weight, age, clinical circumstances and local treatment guidelines. Schistosomiasis regimens can differ by species and program; liver fluke, intestinal tapeworm and cysticercosis regimens are not interchangeable. Take only as prescribed. Follow the approved label regarding meals, dose intervals, tablet splitting and administration.

9. Side Effects and Precautions

• Possible adverse effects include abdominal discomfort, nausea, headache, dizziness and drowsiness.
• Use caution with driving or machinery if dizzy or drowsy.
• Potential drug interactions can alter praziquantel exposure; review all medicines with the prescriber.
• Neurocysticercosis treatment may provoke inflammatory reactions and seizures and requires specialist supervision.
• Use during pregnancy or breastfeeding should follow professional advice and current local guidance.

10. Storage Instructions

Store according to the approved pack label, protected from unsuitable heat and moisture. Keep in the original packaging and out of reach of children. The exact temperature limit and shelf life must be confirmed from approved stability data.

Important: This is general product information for professional review, not individual prescribing advice. Manufacturing, certification and regulatory claims require documentary confirmation.