Description

Loratadine Tablets (10mg)

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 Loratadine Tablets in India. Loratadine is a widely used Second-Generation Antihistamine known for its powerful anti-allergic properties without the sedative effects (drowsiness) common in older drugs. It provides 24-hour relief from symptoms of Seasonal Allergic Rhinitis (Hay Fever) and Chronic Idiopathic Urticaria (Hives).

We offer Contract Manufacturing (Third Party) services for this high-volume OTC and prescription drug. Loratadine is practically insoluble in water. Our WHO-GMP certified facility in Mumbai utilizes advanced Micronization Technology to reduce the particle size of the API, ensuring rapid dissolution and consistent bioavailability. Healthy Inc manages the export logistics, supplying pharmacy chains, supermarkets, and healthcare distributors across the USA, Europe, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Bioavailability and “Non-Drowsy” performance are the goals.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronization: Loratadine is hydrophobic (water-hating). If used in its raw form, it would not dissolve in the stomach. We use Micronized API (< 5 microns) to drastically increase the surface area, ensuring the drug releases rapidly (< 15 mins) for quick onset of action.

  • Direct Compression: We use specialized excipients (like Spray Dried Lactose and Microcrystalline Cellulose) that allow for direct compression. This creates a tablet that is hard enough to withstand shipping but breaks down instantly in the gut.

  • Purity: We strictly monitor for related substances to ensure the product remains safe and effective over its 3-year shelf life.

• The Exporter: Healthy Inc

  • OTC Packaging: We offer retail-ready packaging (blisters with hanging cards) for Over-The-Counter markets, complete with patient information leaflets and barcodes.

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 to ensure safety.

5. Why Use Loratadine?

It blocks the allergy signal without blocking your brain.

• Mechanism: Loratadine is a selective peripheral H1-receptor antagonist. It blocks the action of histamine (the chemical that causes itching, sneezing, and runny nose) on receptor sites outside the brain. Because it does not cross the Blood-Brain Barrier (BBB) easily, it does not cause the sedation/drowsiness associated with older antihistamines like Diphenhydramine.

• Key Indications:

  • Hay Fever: Sneezing, runny nose, itchy/watery eyes, and itching of the nose or throat.

  • Hives: Chronic Idiopathic Urticaria (itchy skin rash).

• Advantage: Unlike Chlorpheniramine, it allows patients to drive, work, and study without feeling sleepy.

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 Loratadine Tablets?

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

• Q: Is it Claritin?

  A: Claritin is the brand name (Bayer). We manufacture the Generic Equivalent (Loratadine), which contains the exact same active ingredient and works the same way.

• Q: Will it make me sleepy?

  A: No. Loratadine is classified as “non-sedating.” However, in very rare cases (dose-dependent), some sensitive individuals may feel mild drowsiness.

• Q: How fast does it work?

  A: It typically starts working within 1 to 3 hours, with peak effect at 8-12 hours. It lasts for a full 24 hours.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults & Children (6+ years): 10mg (one tablet) once daily.

• Children (2-5 years): 5mg (half tablet) once daily (syrup is preferred for this age).

• Renal/Hepatic Impairment: Start with 10mg every other day.

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

9. Side Effects and Precautions

• Headache: The most common side effect.

• Dry Mouth: Mild anticholinergic effect.

• Fatigue: Rare, but possible.

• Pregnancy: Generally considered safe (Category B), but consult a doctor.

• Interaction: Caution with Ketoconazole, Erythromycin, or Cimetidine (they increase Loratadine levels, though usually without clinical consequences).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from excessive moisture.