Description

Ofloxacin Tablets (200mg / 400mg)

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 Ofloxacin Tablets in India. Ofloxacin is a second-generation Fluoroquinolone Antibiotic known for its potent broad-spectrum activity. It is widely regarded as a drug of choice for treating Typhoid Fever (Enteric Fever), Urinary Tract Infections (UTIs), and various respiratory and skin infections.

We offer Contract Manufacturing (Third Party) services for this essential antibiotic. Ofloxacin is chemically sensitive to light and has an intensely bitter taste. Our WHO-GMP certified facility in Mumbai utilizes advanced film-coating systems to provide light protection and effective taste masking, ensuring patient compliance. Healthy Inc manages the export logistics, supplying pharmacy chains and hospitals across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Stability and palatability are key.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Taste Masking: Ofloxacin is exceptionally bitter. We use a high-quality Hydroxypropyl Methylcellulose (HPMC) Film Coating that completely seals the core, preventing the bitter taste from being released in the mouth during swallowing.

  • Photosensitivity Protection: The API degrades when exposed to UV light. We manufacture under controlled lighting conditions and use opaque coating materials (Titanium Dioxide) and Alu-Alu Packaging to ensure the drug remains stable throughout its shelf life.

  • Dissolution: We optimize the disintegration time to ensure the drug releases rapidly in the stomach for quick absorption and onset of action.

• The Exporter: Healthy Inc

  • Tropicalized Packaging: We recommend Alu-Alu Blisters for export to hot and humid climates to provide the best barrier against light and moisture.

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 impurities (like N-oxide derivatives) to ensure safety.

5. Why Use Ofloxacin?

It is a versatile “Workhorse” antibiotic.

• Mechanism: It inhibits bacterial DNA gyrase and Topoisomerase IV, enzymes necessary for bacterial DNA replication, transcription, repair, and recombination. This kills the bacteria (bactericidal).

• Key Indications:

  • Typhoid Fever: Highly effective against Salmonella typhi.

  • UTIs: Treats bladder and kidney infections (cystitis/pyelonephritis).

  • Respiratory: Bronchitis and Pneumonia.

  • STD: Gonorrhea and non-gonococcal urethritis.

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 Ofloxacin Tablets?

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

• Q: Can I take this with milk or antacids?

  A: NO. Dairy products (Calcium), Antacids (Magnesium/Aluminum), and Iron supplements bind to Ofloxacin in the stomach, preventing absorption. Take 2 hours apart.

• Q: Is it safe for children?

  A: Generally Avoided. Fluoroquinolones can affect joint/cartilage development in growing children. It is used only in severe cases where benefits outweigh risks.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Typhoid Fever: 200mg to 400mg twice daily for 7-14 days.

• UTI: 200mg twice daily for 3-7 days.

• Respiratory: 400mg twice daily.

• Administration: Swallow whole with water. Drink plenty of fluids to prevent crystalluria.

9. Side Effects and Precautions

• Tendonitis: Black Box Warning: Increased risk of tendon rupture (Achilles tendon), especially in elderly patients or those on steroids.

• Photosensitivity: Skin becomes very sensitive to sunlight. Avoid tanning beds and direct sun exposure.

• CNS Effects: Dizziness, insomnia, and headache.

• QT Prolongation: Use with caution in heart patients.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.