Codeine Phosphate Tablets 

Healthy Inc is a specialized global supplier and exporter of advanced pain management, palliative care, and targeted high-containment narcotic therapeutics. We provide ultra-high-purity, kinetically stabilized Codeine Phosphate Tablets (15 mg / 30 mg / 60 mg), manufactured in WHO–GMP certified, strictly audited, and highly secured oral solid dosage facilities. This “Prodrug Opiate Analgesic & Antitussive” is a massive-volume, highly regulated export to oncology networks, acute trauma centers, state-run pharmacy chains, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, Step-2 intervention for mild-to-moderate refractory pain and severe, non-productive coughs.


Product Overview

This highly advanced formulation operates as a centralized, biochemical pain dampener. It is a naturally occurring phenanthrene alkaloid (derived from the opium poppy) that acts as a prodrug, relying on the patient’s own liver enzymes to convert it into a highly potent painkiller that intercepts pain signals before they can be processed by the brain.

The “CYP2D6 Prodrug & Central Antitussive” Specialist:

  • Mechanism 1 (The CYP2D6 Hepatic Conversion): Codeine itself is a very weak analgesic. Its true clinical power is unlocked in the liver, where the Cytochrome P450 2D6 (CYP2D6) enzyme actively demethylates roughly 5% to 10% of the Codeine payload into Morphine. This newly synthesized morphine then crosses into the central nervous system to exert profound pain relief.
  • Mechanism 2 (Mu-Opioid Receptor Agonism): The active morphine metabolite binds aggressively to mu-opioid receptors located throughout the brain and spinal cord. This violent binding hyperpolarizes the neurons, physically blocking the transmission of ascending nociceptive (pain) signals and altering the patient’s emotional response to the trauma.
  • Mechanism 3 (The Medullary Cough Blockade): Independent of its conversion to morphine, intact Codeine binds directly to distinct receptors in the cough center of the medulla oblongata. It violently suppresses the neurological cough reflex, making it one of the most effective agents in the world for halting severe, exhausting, dry (unproductive) coughs that prevent patient rest.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Ministry of Health Procurement Boards, and National Narcotic Control Agencies.

HS Code3004.49.00 (Medicaments containing alkaloids or derivatives thereof – Controlled Substances)
CAS Number52-28-8 (Codeine Phosphate)
Dosage FormUncoated or Film-Coated Tablet (Immediate Gastric Release)
Export Compliance (CRITICAL)Schedule II / III Controlled Substance (Varies globally). Export is strictly forbidden without the issuance of an original Narcotic Import Certificate from the destination country’s Ministry of Health, matched against an Export Authorization issued by the manufacturing state under International Narcotics Control Board (INCB) quotas.
StorageStore strictly below 25°C in a dry, highly secure vault. Protect heavily from Light.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Narcotic Vault Security & Content Uniformity (CRITICAL COMPLIANCE): Manufacturing Codeine requires absolute regulatory perfection. Our analgesic suites operate under highly restricted access, utilizing continuous CCTV auditing and strict mass-balance reconciliation to guarantee zero API diversion. Furthermore, because Codeine acts on the respiratory center, a poorly blended tablet containing excess API can be fatal. We utilize elite high-shear dry-blending and intensive HPLC batch-testing to guarantee 100% Content Uniformity, ensuring absolute clinical safety for international patients.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of acute pain and respiratory reflexes:

  • Mild to Moderate Pain: Step 2 on the WHO Analgesic Ladder; relief of acute somatic, dental, or post-operative pain that does not respond to Paracetamol or NSAIDs alone.
  • Severe Antitussive: Suppression of exhausting, non-productive (dry) coughs associated with severe respiratory tract infections or bronchial trauma.
  • Acute Diarrhea (Off-Label): Due to its opiate nature, it severely slows gastrointestinal motility, making it highly effective for refractory, severe diarrhea when standard agents (like Loperamide) fail.

Dosage & Administration

Recommended Dosage (Strictly as per Physician Guidelines):

  • Standard Adult Analgesia: 30 mg to 60 mg taken orally every 4 to 6 hours as needed. Maximum daily dose should not exceed 240 mg.
  • Standard Adult Antitussive: 15 mg to 30 mg every 4 to 6 hours.
  • Administration: Best taken with food or milk to minimize the severe nausea and vomiting frequently associated with opiate initiation.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

  • BLACK BOX WARNING (Ultra-Rapid Metabolizers & Pediatric Death): CRITICAL ALERT: Approximately 1% to 10% of the global population are genetic “ultra-rapid metabolizers” of CYP2D6. Their livers convert Codeine into massive, toxic amounts of Morphine instantly. This has caused fatal respiratory depression, particularly in children. Codeine is strictly contraindicated in children under 12 years of age, and strictly contraindicated in all pediatric patients (under 18) following tonsillectomy or adenoidectomy.
  • Addiction, Abuse, and Misuse: As an opioid agonist, Codeine exposes users to the risks of addiction, abuse, and misuse, which can lead to overdose and death. It must be prescribed for the shortest duration possible.
  • Severe Constipation: Like all opioids, Codeine violently halts bowel motility. Chronic use guarantees severe constipation; prophylactic laxatives are highly recommended.
  • CNS Depression & Alcohol Interaction: Causes profound sedation. Combining Codeine with alcohol, benzodiazepines, or other CNS depressants will trigger a synergistic effect, resulting in profound sedation, respiratory arrest, coma, and death.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Acute Care Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Analgesics, Controlled Opiates, and Strict Content-Uniformity Assured Formulations. Whether you are looking for a reliable Government Tender Supplier for national palliative care programs in the CIS or a B2B Pharma Marketplace partner for Southeast Asia, our highly regulated logistics network ensures secure, fully INCB-compliant delivery of WHO-GMP certified products.

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