Description

Modafinil Tablets (100mg / 200mg)

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 Modafinil Tablets in India. Modafinil is a premier Eugeroic (Wakefulness-Promoting Agent) used to treat excessive sleepiness associated with Narcolepsy, Obstructive Sleep Apnea (OSA), and Shift Work Sleep Disorder (SWSD). It is also widely recognized globally (off-label) as a potent Nootropic (Smart Drug) for enhancing cognitive function, focus, and alertness.

We offer Contract Manufacturing (Third Party) services for this high-value CNS stimulant. Modafinil is a crystalline powder with poor water solubility. Our WHO-GMP certified facility in Mumbai utilizes advanced Micronization Technology to reduce particle size, ensuring rapid dissolution and consistent bioavailability. Healthy Inc manages the export logistics, supplying pharmacy chains, Nootropic distributors, and hospitals across the USA, UK, Australia, and Europe.

2. Product Specifications

3. Manufacturing Technology

Bioavailability depends entirely on particle engineering.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronization: Modafinil is practically insoluble in water. We use Air Jet Milling to micronize the API to a precise particle size (< 5 microns). This drastically increases the surface area, allowing the drug to dissolve in the stomach fluids for effective absorption. Without this step, the drug would pass through the body unabsorbed.

  • Direct Compression: We use specialized excipients (like Microcrystalline Cellulose) that allow for direct compression, preserving the stability of the molecule while ensuring the tablet is hard enough to withstand shipping but disintegrates rapidly (< 5 minutes) in the gut.

  • Purity: We rigorously control for the S-isomer and R-isomer ratios (though Modafinil is a racemic mixture) and limit sulfone impurities.

• The Exporter: Healthy Inc

  • Discreet Packaging: For specific markets, we offer packaging solutions that are compact and secure, ensuring product integrity during international transit.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

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

• Related Substances: We strictly monitor for degradation products (Modafinil Acid and Modafinil Sulfone) to ensure safety.

5. Why Use Modafinil?

It provides “Clean Energy” without the jitteriness of amphetamines.

• Mechanism: Its exact mechanism is complex, but it increases the levels of dopamine (by blocking reuptake), histamine (promoting wakefulness), and orexin in the brain. Unlike traditional stimulants, it does not cause a significant crash or rebound effect.

• Key Indications:

  • Narcolepsy: Reduces the irresistible urge to sleep during the day.

  • Shift Work Disorder: Helps night-shift workers stay awake and alert.

  • Sleep Apnea: Treats residual sleepiness even after CPAP therapy.

  • Cognitive Enhancement: (Off-label) Used by students and professionals to improve focus, memory, and executive function.

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 Modafinil Tablets?

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

• Q: Is it addictive?

  A: Low Risk. Modafinil has a much lower potential for abuse and dependence compared to traditional stimulants like Adderall or Ritalin, but it is still a controlled substance in many countries.

• Q: Does it interfere with sleep?

  A: Yes. Because it has a long half-life (12-15 hours), taking it after noon can cause insomnia at night. It is best taken early in the morning.

• Q: Is it safe for the liver?

  A: Generally yes, but it is metabolized by the liver. Dosage adjustments are needed for patients with severe liver disease.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Narcolepsy/OSA: 200mg once daily in the morning.

• Shift Work Disorder: 200mg taken 1 hour before the start of the work shift.

• Administration: Swallow whole with water. Can be taken with or without food (food may delay absorption slightly).

9. Side Effects and Precautions

• Headache: The most common side effect. Hydration helps.

• Skin Rash: Rare but Serious. Stop immediately if a rash appears (risk of Stevens-Johnson Syndrome).

• Psychiatric: Can cause anxiety, nervousness, or agitation in sensitive individuals.

• Contraceptives: Modafinil reduces the effectiveness of hormonal birth control pills. Use backup protection.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.