Description

Temazepam Tablets (7.5mg / 15mg / 22.5mg / 30mg)

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 Temazepam Tablets in India. Temazepam is a widely prescribed Benzodiazepine Hypnotic indicated for the short-term treatment of Insomnia (difficulty falling asleep or staying asleep). It acts by slowing down the central nervous system (CNS), inducing sedation and sleep.

We offer Contract Manufacturing (Third Party) services for this controlled substance. Handling psychotropic medications requires strict regulatory compliance and security. Our WHO-GMP certified facility in Mumbai is equipped with secure access-controlled suites for the manufacturing of sensitive CNS drugs. Healthy Inc manages the specialized export logistics, ensuring compliance with international narcotic and psychotropic substance regulations.

2. Product Specifications

3. Manufacturing Temazepam Tablets

Manufacturing benzodiazepines requires high security and precision.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Controlled Manufacturing: As a psychotropic substance, Temazepam is processed in restricted-access areas to prevent diversion.

  • Content Uniformity: The drug is potent in low doses (e.g., 7.5mg). We use high-shear granulation to ensure the active ingredient is perfectly distributed, preventing “hot spots” in the batch.

  • Safety: We utilize dedicated equipment or validated cleaning protocols to prevent cross-contamination with other products.

• The Exporter: Healthy Inc

  • Regulatory Expertise: Exporting psychotropics requires specific licenses (like Narcotic Commissioner approval in India and Import Permits from the destination country). Healthy Inc handles this complex paperwork.

  • Secure Logistics: We ensure secure, trackable shipping to prevent theft or loss during transit.

4. Quality Assurance

We adhere to strict Pharmacopoeial and Regulatory standards:

• Dissolution: We test to ensure the drug releases within the specified timeframe (usually rapid release) to induce sleep quickly.

• Assay: We confirm potency is strictly within 90-110% limits.

• Impurity Profiling: We monitor for related benzodiazepine impurities to ensure safety.

5. Why Use Temazepam?

It is effective for transient insomnia.

• Mechanism: Temazepam binds to benzodiazepine receptors on the GABA-A chloride ionophore complex. This enhances the inhibitory effect of GABA (gamma-aminobutyric acid), leading to sedation, muscle relaxation, and sleep induction.

• Key Indications:

  • Insomnia: Specifically useful for patients who have trouble falling asleep or who wake up frequently during the night.

  • Pre-operative Sedation: Sometimes used to calm patients before surgery.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

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

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF) with Controlled Substance handling.

7. Frequently Asked Questions

• Q: Who manufactures Temazepam Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India under strict regulatory controls.

• Q: Is this a controlled drug?

  A: Yes, it is a Schedule IV controlled substance in the US and a Psychotropic substance in India. Import requires a specific license.

• Q: What is the difference between Temazepam and Diazepam?

  A: Temazepam is primarily used for sleep (hypnotic), while Diazepam is often used for anxiety and muscle spasms (anxiolytic).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adult Dose: Typically 15mg to 30mg taken 30 minutes before bedtime.

• Elderly Dose: Start with 7.5mg to reduce the risk of over-sedation and falls.

• Administration: Take only if you are able to get a full night’s sleep (7-8 hours).

9. Side Effects and Precautions

• Common Side Effects: Drowsiness, dizziness, “hangover” effect the next morning, and headache.

• Dependence: Boxed Warning: Benzodiazepines expose users to risks of abuse, misuse, and addiction. Use for the shortest duration possible (usually 7-10 days).

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

• Interaction: Fatal if combined with opioids or alcohol.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly out of reach of children. Secure storage is recommended.