Description

Clobazam Tablets (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 Clobazam Tablets in India. Clobazam is a long-acting 1,5-Benzodiazepine used primarily as an adjunctive therapy for Epilepsy and severe anxiety. Unlike classic 1,4-benzodiazepines (like Diazepam), Clobazam has a unique chemical structure that creates a stronger anticonvulsant effect with significantly less sedation and fewer cognitive side effects, making it ideal for long-term seizure management.

We offer Contract Manufacturing (Third Party) services for this controlled neurological medication. Clobazam is a Schedule H/X drug (depending on the region) requiring strict compliance and security during manufacturing. Our WHO-GMP certified facility in Mumbai adheres to rigorous protocols for controlled substance handling. We utilize advanced granulation techniques to ensure precise dosing, which is critical for pediatric patients with syndromes like Lennox-Gastaut. Healthy Inc manages the secure export logistics, supplying neurology centers and hospitals across Europe, Canada, Australia, and select Asian markets.

2. Product Specifications

3. Manufacturing Technology

Targeted seizure control with reduced drowsiness.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Structure Optimization: Standard benzodiazepines are “1,4-benzodiazepines”. Clobazam is a “1,5-benzodiazepine”. This slight shift in the nitrogen position reduces the affinity for receptors that cause sleepiness while maintaining binding to receptors that stop seizures. We ensure the synthesis and formulation preserve this structural integrity.

  • Scored Tablets: Since dosing is strictly weight-based (especially in children), our tablets are deeply scored to allow for easy and accurate splitting (e.g., breaking a 10mg tablet into 5mg doses).

  • Dissolution Profile: We engineer the tablet to dissolve consistently to avoid peak-dose side effects (like sudden drowsiness) while maintaining steady blood levels for 24-hour coverage.

• The Exporter: Healthy Inc

  • Controlled Supply Chain: We have specialized licenses and secure logistics partners to handle the export of psychotropic substances in full compliance with international narcotics control board (INCB) regulations.

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.

• Related Substances: We strictly monitor for organic impurities to ensure long-term safety.

5. Why Use Clobazam?

Powerful seizure protection that lets you stay awake.

• • Mechanism: Clobazam binds to the GABA-A Receptor at a specific site (the benzodiazepine site).

It enhances the effect of GABA, the brain’s main calming neurotransmitter. By opening chloride channels more frequently, it hyperpolarizes neurons, making them less likely to fire rapidly and start a seizure.

• Key Indications:

  • Lennox-Gastaut Syndrome (LGS): A severe form of childhood epilepsy. Clobazam is a first-line add-on treatment.

  • Refractory Epilepsy: Used when other drugs (like Sodium Valproate or Carbamazepine) fail to fully control seizures.

  • Severe Anxiety: Short-term relief of severe, disabling anxiety (second-line).

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) with all necessary Narcotics Export Authorizations.

7. Frequently Asked Questions

• Q: Who manufactures Clobazam Tablets?

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

• Q: Is it Frisium or Onfi?

  A: Frisium (Sanofi) and Onfi (Lundbeck) are brand names. We manufacture the Generic Equivalent (Clobazam).

• Q: Is it addictive?

  A: Yes. Like all benzodiazepines, physical dependence can occur with long-term use. It must never be stopped suddenly due to the risk of withdrawal seizures.

• Q: Can I drive while taking it?

  A: Caution. While less sedating than Valium, it can still slow reaction times. Do not drive until you know how it affects you.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Epilepsy (Adults): Start 5-10mg daily. Maintenance 20-30mg daily (Max 60mg).

• Pediatrics (>2 years): Weight-based dosing (Start 0.1 mg/kg/day).

• Administration: Can be taken with or without food. Can be crushed and mixed with applesauce for children.

9. Side Effects and Precautions

• CNS: Somnolence (sleepiness), drooling (in children), coordination difficulties (ataxia).

• Skin: Serious Skin Reactions (SJS/TEN) have been reported rarely. Seek help if a rash appears.

• Respiratory: Caution in patients with sleep apnea or respiratory weakness.

• Interaction: Cannabidiol (Epidiolex) can significantly increase Clobazam levels. Dose adjustment is needed.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly out of reach of children.