Description

Lorazepam Tablets (0.5mg / 1mg / 2mg)

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 Lorazepam Tablets in India. Lorazepam is a high-potency Benzodiazepine used for the short-term management of Anxiety Disorders, Insomnia associated with anxiety, and as a Pre-anesthetic Medication to induce sedation and amnesia before surgery.

We offer Contract Manufacturing (Third Party) services for this Psychotropic / Controlled Substance. Handling benzodiazepines requires specific manufacturing licenses and strict security protocols. Our WHO-GMP certified facility in Mumbai is fully licensed to manufacture psychotropic substances, ensuring full compliance with the Narcotics Control Bureau (NCB) guidelines. Healthy Inc manages the complex documentation required for exporting controlled substances to authorized importers globally.

2. Product Specifications

3. Manufacturing Technology

Safety and compliance are the manufacturing pillars.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Content Uniformity (Low Dose): Lorazepam is potent in very small doses (0.5mg). We use High-Shear Granulation and Geometric Dilution blending techniques to ensure the active ingredient is perfectly distributed. This prevents “hot spots” (super-potent tablets) which could be dangerous.

  • Controlled Environment: The manufacturing suite is access-controlled with biometric security to prevent diversion or theft, adhering to strict regulatory standards for psychotropics.

  • Direct Compression: We utilize excipients that allow for direct compression to maintain the stability of the molecule, which can be sensitive to moisture and heat.

• The Exporter: Healthy Inc

  • Regulatory Documentation: Exporting psychotropics requires an Export Authorization from India and an Import Permit from the destination country. We have a dedicated regulatory team to manage this complex paperwork, ensuring legal and smooth transit.

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 degradation products (like Quinazolinone derivative) to ensure safety.

5. Why Use Lorazepam?

It is safer for the elderly and those with liver issues.

• • Mechanism: It binds to the benzodiazepine site on the GABA-A receptor, enhancing the effect of GABA (a calming neurotransmitter). This opens chloride channels, hyperpolarizing the neuron and reducing brain activity (sedation).

     

• Key Indications:

  • Anxiety: Rapid relief of severe anxiety or panic attacks.

  • Insomnia: Short-term treatment of sleeplessness caused by anxiety.

  • Pre-medication: Relieves anxiety and causes memory loss (anterograde amnesia) before surgical procedures.

• Advantage (The “Clean” Benzo): Unlike Diazepam, Lorazepam does not have active metabolites and is metabolized purely by Glucuronidation. This makes it much safer for elderly patients or those with liver impairment, as it is less likely to accumulate in the body.

6. Export and Regulatory Support

We streamline the strict compliance process for our B2B partners:

• Psychotropic Licenses: We hold valid manufacturing and export licenses.

• Dossier Support: We offer CTD and ACTD Dossiers for registration.

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

7. Frequently Asked Questions

• Q: Who manufactures Lorazepam Tablets?

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

• Q: Is it Ativan?

  A: Ativan is the brand name (Pfizer). We manufacture the Generic Equivalent (Lorazepam), which is bioequivalent.

• Q: Is it addictive?

  A: YES. All benzodiazepines carry a high risk of dependence and addiction. It is meant for short-term use only (2-4 weeks).

• Q: Can I drink alcohol with it?

  A: ABSOLUTELY NOT. Combining Lorazepam with alcohol or opioids can cause fatal Respiratory Depression (stopping breathing).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Anxiety: 1mg to 3mg daily in divided doses (e.g., 0.5mg twice daily).

• Insomnia: 2mg to 4mg at bedtime.

• Pre-medication: 2mg the night before or 1-2 hours before surgery.

• Administration: Swallow whole. Can be taken with food if stomach upset occurs.

9. Side Effects and Precautions

• Sedation: Drowsiness, dizziness, unsteadiness (risk of falls in elderly).

• Dependence: Boxed Warning: Risk of abuse, misuse, and addiction. Withdrawal symptoms (seizures, tremors) can occur if stopped suddenly.

• Respiratory Depression: Use with extreme caution in patients with COPD or sleep apnea.

• Paradoxical Reactions: Rarely, can cause agitation or rage instead of sedation (especially in children/elderly).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.

• Secure Storage: Keep in a locked cabinet away from potential abuse.