Description
Chlordiazepoxide Hydrochloride Tablets (10mg / 25mg)
Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc
1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Chlordiazepoxide Hydrochloride Tablets in India. This was the very first Benzodiazepine discovered and remains a critical medication for the management of Anxiety Disorders and the safe treatment of Acute Alcohol Withdrawal symptoms. We produce high-purity, sugar-coated tablets. Our facility adheres to strict WHO-GMP standards and Narcotics Control Bureau (NCB) regulations. Healthy Inc manages our global exports and psychiatric tenders.
2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Chlordiazepoxide Hydrochloride Tablets | | Generic Name | Chlordiazepoxide Hydrochloride USP / BP / IP | | Strength | 5mg / 10mg / 25mg | | Dosage Form | Sugar Coated Tablet / Film Coated Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Benzodiazepine / Anxiolytic / Sedative | | Shelf Life | 36 Months | | Packaging | 10×10 Blister / 1000s Bulk Jar |
3. Manufacturing Chlordiazepoxide Tablets We divide our operations to ensure specialized focus.
The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Chlordiazepoxide has a bitter taste and is sensitive to light. We typically use Sugar Coating or Opaque Film Coating to mask the taste completely and protect the core from UV degradation. As this is a controlled substance, our manufacturing suite has Biometric Access Control and strict inventory reconciliation protocols to prevent diversion, ensuring 100% regulatory compliance.
The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Chlordiazepoxide Tablets. We are experts in obtaining the necessary Export Authorization and No Objection Certificates (NOC) from Indian authorities. We assist our international partners in securing their Import Permits to ensuring a smooth customs clearance process for psychotropic goods.
4. Quality Assurance We test every batch rigorously.
Dissolution: We test how the tablet releases the drug. Consistent release is vital for preventing “dose dumping” which could lead to excessive sedation.
Assay & Related Substances: We confirm the potency and purity using HPLC. We monitor for the specific impurity 2-Amino-5-chlorobenzophenone to ensure stability.
Uniformity: We ensure every tablet contains the exact dose to maintain a stable therapeutic effect.
5. Why Use Chlordiazepoxide Tablets? This drug calms the central nervous system.
Mechanism: It enhances the effect of GABA (gamma-aminobutyric acid), a natural calming chemical in the brain. It binds to benzodiazepine receptors, opening chloride channels and reducing neuron excitability.
Effect: It produces sedation, reduces anxiety, relaxes muscles, and prevents seizures during alcohol withdrawal.
Key Indications:
Alcohol Withdrawal: The Gold Standard for preventing tremors, agitation, and delirium tremens (DTs) in patients stopping alcohol.
Anxiety Disorders: Short-term management of severe anxiety and tension.
Pre-operative Anxiety: Used to calm patients before surgery.
6. Export and Regulatory Support We provide complete documentation for registration.
Dossier: We offer CTD and ACTD formats.
Certificates: We supply the Free Sale Certificate (FSC) and COPP.
Logistics: We ship via FOB Mumbai or CIF (Strictly adhering to Psychotropic shipping guidelines).
7. Frequently Asked Questions
Q: Who manufactures Chlordiazepoxide Tablets?A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Is this a controlled substance?A: Yes, it is a Psychotropic substance. Importers must have a valid Import License for psychotropics in their country.
Q: Why sugar coating?A: It is the traditional method to seal the bitter taste and provide a glossy, professional finish that patients trust.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Alcohol Withdrawal: High initial dose (e.g., 50-100mg), followed by repeated doses as needed, then tapered down over several days.
Anxiety: 5mg to 25mg three or four times daily.
Geriatric: Dose must be reduced (e.g., 5mg) in elderly patients to prevent falls and confusion.
Administration: Swallow whole.
9. Side Effects and Precautions
Sedation: Drowsiness, dizziness, and ataxia (loss of balance) are common. Do not drive or operate machinery.
Dependence: Long-term use can lead to physical dependence. Do not stop abruptly; taper slowly to avoid withdrawal seizures.
Respiratory Depression: Use with extreme caution in patients with COPD or sleep apnea.
Interaction: Fatal overdose risk if combined with Opioids or Alcohol.
10. Storage Instructions
Store below 25°C in a dry place.
Critical: Protect from light.
Keep in a secure place out of reach of children and potential abusers.
