Description

Levocetirizine Tablets (5mg)

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 Levocetirizine Dihydrochloride Tablets in India. Levocetirizine is a Third-Generation Antihistamine and the active enantiomer of Cetirizine. It offers a significant clinical advantage: it is twice as potent as Cetirizine with a much lower incidence of sedation (drowsiness). It is the modern gold standard for the treatment of Allergic Rhinitis (Hay Fever) and Chronic Idiopathic Urticaria (Hives).

We offer Contract Manufacturing (Third Party) services for this high-volume OTC and prescription product. Levocetirizine is a low-dose (5mg) potent drug. Our WHO-GMP certified facility in Mumbai utilizes high-precision Direct Compression technology to ensure perfect content uniformity. The tablets are film-coated to mask the bitter taste of the API and improve stability. Healthy Inc manages the export logistics, supplying pharmacy chains, supermarkets, and ENT clinics across Europe, Southeast Asia, and the Americas.

2. Product Specifications

3. Manufacturing Technology

Refining the molecule for better relief.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Enantiomeric Purity: The efficacy of Levocetirizine depends on it being the pure “Levo” form. We use high-grade API with strict optical rotation controls to ensure no “Dextro” (inactive/sedative) form is present.

  • Content Uniformity: A 5mg active dose requires precise mixing. We employ Geometric Dilution and automated weight control systems on our compression lines to ensure every tablet delivers exactly 5mg, preventing under-dosing.

  • Taste Masking: Like its parent molecule, Levocetirizine is bitter. We apply a thin, rapidly dissolving Opadry Film Coat that masks the taste instantly upon contact with the tongue.

• The Exporter: Healthy Inc

  • Combination Packs: We are experienced in manufacturing “Cold & Flu” combinations, such as Levocetirizine + Montelukast (for asthma/rhinitis) and Levocetirizine + Phenylephrine (for congestion).

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes in 0.1N HCl.

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

• Related Substances: We strictly monitor for degradation products and enantiomeric impurities.

5. Why Use Levocetirizine?

Potency without the sleepiness.

• Mechanism: Levocetirizine is a potent and selective Inverse Agonist at Peripheral H1 Receptors.

  • Histamine Blockade: It prevents Histamine from binding to receptors on blood vessels and nerves, stopping the “Allergic Cascade” (itching, sneezing, swelling).

  • Why “Levo”? It binds to the receptor 2x stronger than Cetirizine and dissociates slower, providing 24-hour relief from a single small dose.

• Key Indications:

  • Allergic Rhinitis: Seasonal (pollen) and Perennial (dust mites/pets). Stops runny nose, sneezing, and watery eyes.

  • Urticaria: Reduces the number, size, and duration of hives and relieves severe itching.

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 Levocetirizine Tablets?

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

• Q: Is it Xyzal?

  A: Xyzal is the brand name (Sanofi/UCB). We manufacture the Generic Equivalent (Levocetirizine), which is bioequivalent.

• Q: Is it non-drowsy?

  A: Mostly Yes. It is classified as “non-sedating,” but a small percentage of people may still feel mild sleepiness. It is much less sedating than Cetirizine.

• Q: Can I take it for a cold?

  A: Yes. It effectively dries up a runny nose and stops sneezing associated with the common cold.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults & Children (12+ yrs): 5mg once daily.

• Children (6-11 yrs): 2.5mg (half tablet) once daily.

• Renal Impairment: Dosage adjustment is mandatory (e.g., 5mg every other day) as the drug is excreted by the kidneys.

• Administration: Swallow whole with liquid. Can be taken with or without food. Best taken in the evening.

9. Side Effects and Precautions

• CNS: Somnolence (mild), fatigue, dry mouth.

• Urinary: Urinary retention (caution in patients with enlarged prostate).

• Contraindications: End-stage renal disease (CrCl < 10 ml/min).

• Interaction: Avoid alcohol and other CNS depressants as they may increase drowsiness.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.