Description

Azithromycin Tablets (250mg / 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 Azithromycin Tablets in India. Azithromycin is a broad-spectrum Macrolide Antibiotic (specifically an Azalide) known for its exceptional tissue penetration and long half-life. This unique pharmacokinetic profile allows for the famous “3-Day Course” (Z-Pack) which treats infections that typically require 7-10 days of older antibiotics.

We offer Contract Manufacturing (Third Party) services for this high-volume essential medicine. Azithromycin has low water solubility and an intensely bitter taste. Our WHO-GMP certified facility in Mumbai utilizes Micronization technology to enhance bioavailability and specialized Taste-Masking Film Coating to ensure patient compliance. Healthy Inc manages the export logistics, supplying government tenders, STD clinics, and hospital chains across the USA, Africa (for Typhoid/STI), and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Short course, long-lasting effect.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Solubility Enhancement: Azithromycin is a Class II drug (Low Solubility). We strictly use Micronized Azithromycin Dihydrate to ensure rapid dissolution in the stomach. This guarantees that the drug reaches peak blood levels quickly to start fighting the infection.

  • Taste Masking: The drug is extremely bitter. We employ a specialized Opadry Non-Functional Coating that creates a tasteless barrier, preventing the tablet from dissolving in the mouth while ensuring immediate release once swallowed.

  • Batch Consistency: We use automated granulation systems to ensure the ratio of excipients (like disintegration agents) is perfect, preventing “batch-to-batch” variation in how the drug is absorbed.

• The Exporter: Healthy Inc

  • Kit Formats: We specialize in the “1-Gram Single Dose” pack (1 tablet of 1000mg) used globally for the single-dose treatment of Chlamydia and Gonorrhea, as well as the standard 3-Tablet Blister for respiratory infections.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

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

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

• Impurity Profiling: We strictly monitor for degradation products (N-demethyl azithromycin) to ensure safety.

5. Why Use Azithromycin?

The antibiotic that travels to the infection site.

• Mechanism: Azithromycin binds to the 50S ribosomal subunit of the bacteria. It blocks the exit tunnel for the growing peptide chain, effectively stopping bacterial protein synthesis (Bacteriostatic/Bactericidal).

• The “Trojan Horse” Effect: Unlike other antibiotics that float in the blood, Azithromycin is actively taken up by White Blood Cells (Phagocytes). These cells travel to the infection site and release the antibiotic directly onto the bacteria. This results in tissue concentrations 50x higher than blood levels.

• Key Indications:

  • Respiratory: Bronchitis, Pneumonia, Sinusitis (3-day course).

  • STIs: Single-dose cure for Chlamydia trachomatis and Gonorrhea.

  • Typhoid: Effective against drug-resistant Salmonella typhi.

  • Skin: Infections caused by Staph or Strep.

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 Azithromycin Tablets?

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

• Q: Is it Zithromax?

  A: Zithromax (Z-Pak) is the brand name (Pfizer). We manufacture the Generic Equivalent (Azithromycin), which works exactly the same.

• Q: Why only 3 days?

  A: Long Half-Life. Azithromycin stays in your body for up to 68 hours. A 3-day course continues to work for 7-10 days after you take the last pill.

• Q: Can I drink alcohol?

  A: Moderately. Alcohol doesn’t make the drug toxic, but it can increase liver stress and side effects like nausea.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Respiratory / Skin: 500mg once daily for 3 days.

• STI (Chlamydia): 1000mg (1g) as a Single Dose.

• Typhoid: 500mg once daily for 7 days.

• Administration: Swallow whole. Can be taken with or without food (though food reduces stomach upset).

9. Side Effects and Precautions

• Gastrointestinal: Diarrhea, nausea, abdominal pain (very common).

• Cardiac: QT Prolongation (Heart rhythm issue). Avoid in patients with history of arrhythmias or those taking other QT-prolonging drugs.

• Liver: Rare risk of hepatotoxicity. Stop if jaundice occurs.

• Interaction: Caution with Digoxin, Warfarin, and Statins.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture.