Description

Phenobarbital Tablets (30mg – 100mg)

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 Phenobarbital Tablets in India. Phenobarbital is the oldest and most widely used Barbiturate Anticonvulsant globally. It is listed on the WHO Model List of Essential Medicines as a first-line treatment for epilepsy in developing countries due to its high efficacy and cost-effectiveness.

We offer Contract Manufacturing (Third Party) services for this Controlled Substance (Psychotropic). Manufacturing Phenobarbital requires specific regulatory licenses and high-security infrastructure. Our WHO-GMP certified facility in Mumbai is fully equipped with secure storage vaults and authorized access zones to handle scheduled drugs compliantly. Healthy Inc manages the complex export logistics, assisting partners with Psychotropic Export/Import Permits to supply government tenders and NGOs across Africa, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Security and precision are the twin pillars of production.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Regulatory Compliance: As a psychotropic substance, every gram of API is accounted for. We use Automated Reconciliation Systems during granulation and compression to ensure zero yield loss and full traceability for regulatory audits.

  • Content Uniformity: Phenobarbital is often used in low doses (30mg). We use Geometric Mixing and high-precision compression tooling to ensure that every tablet contains the exact dose, which is critical for maintaining steady blood levels and preventing seizures.

  • Hardness: We compress tablets to a specific hardness that prevents crumbling during transport in bulk jars (common for tender supplies) but ensures they still dissolve quickly in the stomach.

• The Exporter: Healthy Inc

  • Controlled Logistics: We are experienced in handling Narcotic/Psychotropic logistics, including obtaining the necessary NOCs (No Objection Certificates) from the Narcotics Commissioner of India and coordinating with the importing country’s regulatory body for Import Permits.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

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

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

• Friability: Strictly controlled (< 1%) to ensure tablets do not break in bulk packaging.

5. Why Use Phenobarbital?

It is the “Gold Standard” for affordable epilepsy control.

• Mechanism: It acts on GABA-A receptors, increasing the duration that the chloride channel is open. This depresses the central nervous system, calming the excessive electrical activity that causes seizures.

• Key Indications:

  • Epilepsy: Generalized tonic-clonic (grand mal) seizures and partial seizures.

  • Status Epilepticus: Used to stop continuous seizures.

  • Sedation: Rarely used now for anxiety, but historically used as a sedative.

• Advantage: It has a very long half-life (50-120 hours), meaning it can be taken once a day, making it easier for patients to stick to their treatment.

6. Export and Regulatory Support

We streamline the complex documentation for B2B partners:

• Regulatory Support: Assistance with Form 10 (Import Certificate) processing and Export Authorization from Indian authorities.

• Dossier Support: CTD and ACTD Dossiers available.

• Certificates: COPP (WHO-GMP), COA, and Psychotropic Licenses.

• Logistics: Secure shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Phenobarbital Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India in a licensed controlled substance facility.

• Q: Is it addictive?

  A: Yes. Phenobarbital is a barbiturate and can be habit-forming. It must only be used under strict medical supervision.

• Q: Does it make you sleepy?

  A: Yes. Drowsiness is the most common side effect, though patients often build a tolerance to this over time.

• Q: Can I stop taking it suddenly?

  A: NO. Sudden withdrawal can cause severe, life-threatening seizures (“withdrawal seizures”). Usage must be tapered off slowly.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults (Epilepsy): 60mg to 180mg daily, usually taken at bedtime (due to sedation).

• Children: 3mg to 6mg/kg/day.

• Administration: Swallow whole with water.

9. Side Effects and Precautions

• Sedation: Drowsiness, lethargy, and dizziness.

• Cognitive: Can cause hyperactivity in children or confusion in the elderly.

• Respiratory Depression: High doses can slow breathing. Dangerous if mixed with alcohol or other sedatives.

• Skin: Rare risk of severe rash (Stevens-Johnson Syndrome).

• Pregnancy: Potential teratogen (Category D). Use only if benefits outweigh risks.

10. Storage Instructions

• Store below 25°C in a dry place.

• Secure Storage: Keep in a locked cabinet out of reach of children and unauthorized persons.