Description

Citicoline Tablets (500mg / 1000mg)

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 Citicoline Sodium Tablets in India. Citicoline (also known as CDP-Choline) is a potent Neuroprotective and Nootropic Agent. It acts as an essential precursor for the synthesis of phosphatidylcholine, a major component of brain cell membranes. It is clinically proven to accelerate recovery in patients suffering from Acute Ischemic Stroke, Traumatic Brain Injury (TBI), and age-related cognitive decline (Dementia).

We offer Contract Manufacturing (Third Party) services for this high-value neurological product. Citicoline is extremely hygroscopic (absorbs moisture from the air), which can cause tablets to become sticky or degrade. Our WHO-GMP certified facility in Mumbai utilizes specialized dehumidified manufacturing zones (< 20% RH) and Alu-Alu (Cold Form) Blister Packaging to guarantee stability and shelf-life. Healthy Inc manages the export logistics, supplying neurology centers and rehabilitation clinics across Europe, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Rebuilding the brain, molecule by molecule.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Moisture Defense: Citicoline loves water. To prevent degradation, we manufacture in low-humidity suites and use Alu-Alu Cold Form Blisters, which provide a 100% barrier against moisture and light, ensuring the tablet remains potent until the moment it is consumed.

  • Direct Compression: We utilize specialized direct compression grades of Citicoline to minimize heat exposure during processing, preserving the delicate chemical structure of the molecule.

  • High-Dose Compaction: Compressing 1000mg of active ingredient into a swallowable tablet is an engineering challenge. We use high-density excipients to keep the tablet size “patient-friendly.”

• The Exporter: Healthy Inc

  • Stroke Recovery Kits: We can bundle Citicoline with other neuro-rehab drugs (like Piracetam) for comprehensive post-stroke care packages.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

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

• Dissolution: We test release profiles to ensure rapid availability of the drug for absorption.

• Related Substances: We strictly monitor for hydrolysis products (Cytidine and Choline) to ensure stability.

5. Why Use Citicoline?

Fuel for brain repair.

• Mechanism:

  1. Membrane Repair: Citicoline breaks down into Cytidine and Choline. These travel to the brain and are re-synthesized into Phosphatidylcholine, helping to repair damaged neuronal membranes.

  2. Neurotransmitter Boost: It increases the levels of Acetylcholine, Dopamine, and Norepinephrine, improving memory, focus, and attention.

  3. Anti-Apoptotic: It prevents brain cells from dying (apoptosis) in the “penumbra” zone after a stroke.

• Key Indications:

  • Stroke Recovery: Improves functional recovery if started within 24 hours of an ischemic stroke.

  • Head Injury (TBI): Reduces post-concussion symptoms and speeds up cognitive recovery.

  • Dementia / Alzheimer’s: Slows memory loss and improves mental clarity.

  • Glaucoma: (Adjunct) Protects the optic nerve from damage.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

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

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

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

7. Frequently Asked Questions

• Q: Who manufactures Citicoline Tablets?

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

• Q: Is it Somazina?

  A: Somazina is a brand name (Ferrer). We manufacture the Generic Equivalent (Citicoline), which is bioequivalent.

• Q: Is it a stimulant?

  A: Mildly. It increases focus and energy but does not cause the “jitters” or crash associated with amphetamines or caffeine.

• Q: Can healthy people take it?

  A: Yes. It is often used off-label as a “Smart Drug” (Nootropic) by students and professionals to enhance focus and memory.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Acute Stroke / TBI: 500mg to 1000mg twice daily for 6 weeks.

• Chronic Cognitive Decline: 500mg to 1000mg once daily.

• Administration: Swallow whole with water. Can be taken with or without food.

9. Side Effects and Precautions

• Gastrointestinal: Stomach pain, diarrhea (rare).

• CNS: Insomnia (if taken late at night), headache, restlessness.

• Cardiovascular: Mild hypotension (low blood pressure) or bradycardia.

• Contraindications: Patients with hypertonia of the parasympathetic nervous system.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture. (Keep in blister until use).