Description

Tramadol Hydrochloride Tablets (50mg / 100mg SR / 200mg SR)

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 Tramadol Hydrochloride Tablets in India. Tramadol is a centrally acting Synthetic Opioid Analgesic with a unique “dual-action” mechanism. It is widely prescribed for the management of Moderate to Moderately Severe Pain, serving as a crucial therapeutic bridge between NSAIDs (like Ibuprofen) and potent opioids (like Morphine).

We offer Contract Manufacturing (Third Party) services for this high-demand analgesic. Important: Tramadol is a Controlled Substance in many jurisdictions (including India under NDPS Act). Our WHO-GMP certified facility in Mumbai operates with strict regulatory compliance, utilizing secure storage and authorized manufacturing quotas. We employ advanced Hydrophilic Matrix Technology for our Sustained Release (SR) formulations, ensuring 12-24 hour pain relief without the “dose dumping” risks associated with immediate-release opioids. Healthy Inc manages the complex export licensing (Narcotic/Psychotropic clearances), supplying authorized distributors and hospitals globally.

2. Product Specifications

3. Manufacturing Technology

Controlled release, controlled relief.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Matrix SR Technology: For our 100mg and 200mg SR tablets, we use a HPMC Hydrophilic Matrix. When the tablet hits the stomach fluid, it forms a gel layer that slowly releases the drug over 12 to 24 hours. This ensures constant pain control and reduces the euphoria “spike” associated with abuse.

  • Content Uniformity: Tramadol is potent. We use high-precision automated compression machines with weight control feedback loops to ensure every tablet contains exactly the labeled dose, preventing accidental overdose.

  • Taste Masking: Tramadol is incredibly bitter. We use a specialized High-Gloss Film Coating (Opadry) to mask the taste instantly, ensuring the patient can swallow it without gagging.

• The Exporter: Healthy Inc

  • Secure Supply Chain: We handle all necessary Export Authorizations and ensure shipments are tamper-evident and tracked, complying with international narcotics control regulations.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution:

  • Immediate Release: >80% release in 30 minutes.

  • Sustained Release: Specific multi-point testing (1hr, 4hr, 8hr, 12hr) to verify the release curve is smooth and controlled.

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

• Impurity Profiling: Strict monitoring of synthesis by-products (Isomers) to ensure safety.

5. Why Use Tramadol?

The dual-action pain fighter.

• Mechanism: Tramadol is unique because it works in two ways:

  1. Opioid Agonist: It binds weakly to the Mu-Opioid Receptors in the brain to block pain signals (like Morphine, but weaker).

  2. SNR Inhibition: It inhibits the reuptake of Serotonin and Norepinephrine. These neurotransmitters naturally dampen pain signals in the spinal cord.

• Key Indications:

  • Post-Operative Pain: Management of pain after surgery.

  • Trauma: Injury-related pain.

  • Chronic Pain: Conditions like cancer pain or severe osteoarthritis (using SR formulation).

• Advantage: It has a lower risk of respiratory depression (stopping breathing) compared to stronger opioids.

6. Export and Regulatory Support

STRICT COMPLIANCE NOTICE:

• Licensing: Requires specific Import Permits from the destination country and Export Authorization from India’s Central Bureau of Narcotics (CBN).

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

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

7. Frequently Asked Questions

• Q: Who manufactures Tramadol Tablets?

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

• Q: Is it Ultram?

  A: Ultram is the brand name. We manufacture the Generic Equivalent (Tramadol HCl).

• Q: Is it addictive?

  A: Yes. It is an opioid. Prolonged use can lead to physical dependence and addiction. It must only be used under strict medical supervision.

• Q: Can it cause seizures?

  A: Yes. Risk is increased at high doses or if taken with antidepressants (SSRI/SNRI).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Immediate Release (Acute Pain): 50mg to 100mg every 4-6 hours. Max 400mg/day.

• Sustained Release (Chronic Pain): 100mg once or twice daily.

• Administration: Swallow whole. Do not crush or chew SR tablets (this can cause a fatal overdose).

9. Side Effects and Precautions

• CNS: Dizziness, drowsiness, headache, seizures (rare).

• Gastrointestinal: Nausea (very common), vomiting, constipation, dry mouth.

• Serotonin Syndrome: Risk if combined with antidepressants. Symptoms include agitation, fever, and muscle stiffness.

• Contraindications: Acute intoxication with alcohol/hypnotics, MAO Inhibitors (last 14 days), severe respiratory depression.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep out of reach of children. (Crucial safety warning).