Description

Erythromycin Tablets (250mg / 500mg)

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 Erythromycin Tablets in India. Erythromycin is the original Macrolide Antibiotic and remains a vital drug in the global pharmacopeia. It is the primary alternative for patients with Penicillin Allergy and is extensively used to treat respiratory tract infections, skin infections, and sexually transmitted diseases like Chlamydia and Syphilis.

We offer Contract Manufacturing (Third Party) services for this classic antibiotic. Erythromycin is intensely bitter and rapidly degraded by stomach acid. Our WHO-GMP certified facility in Mumbai utilizes advanced Enteric Coating or Film Coating (Stearate form) technology. This ensures the tablet passes through the stomach intact and releases the active drug in the small intestine, maximizing absorption and minimizing gastric irritation. Healthy Inc manages the export logistics, supplying pharmacy chains and government health tenders across Africa, Southeast Asia, and the Middle East.

2. Product Specifications

3. Manufacturing Technology

Protecting the drug from acid and the patient from taste.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Acid Resistance: Pure Erythromycin is acid-labile (destroyed by stomach acid). We manufacture Enteric Coated Tablets (using polymers like Methacrylic Acid Copolymer) that resist the acidic pH of the stomach (pH 1-2) and dissolve only in the neutral pH of the intestines (pH 6+). This preserves the drug’s potency.

  • Taste Masking: The drug has an extremely bitter, metallic taste. Our robust coating integrity ensures the patient does not taste the drug during swallowing, which is critical for compliance.

  • Salt Selection: We offer Erythromycin Stearate (Film Coated) which is more acid-stable than the base, offering a cost-effective option for large-scale tenders.

• The Exporter: Healthy Inc

  • Tender Compliant: We are experienced in supplying bulk hospital packs (1000s) required for national disease control programs (e.g., STI management).

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles in two stages (Acid Stage & Buffer Stage) for enteric tablets to guarantee gastric resistance.

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

• Microbiology: We perform strict bio-assays to ensure the antibiotic activity matches the standard.

5. Why Use Erythromycin?

The safe alternative when Penicillin fails.

• Mechanism: Erythromycin inhibits bacterial protein synthesis by binding reversibly to the 50S ribosomal subunit of the bacteria. This prevents the bacteria from growing and replicating (Bacteriostatic action). At high concentrations, it can be Bactericidal.

• Key Indications:

  • Penicillin Allergy: The go-to drug for Strep Throat or Syphilis in patients allergic to Amoxicillin/Penicillin.

  • Respiratory Infections: Bronchitis, Pneumonia (Mycoplasma/Legionella).

  • Acne: Used for inflammatory acne (kills P. acnes bacteria).

  • STIs: Chlamydia, Gonorrhea, and Syphilis.

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 Erythromycin Tablets?

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

• Q: Is it Erythrocin?

  A: Erythrocin is a brand name. We manufacture the Generic Equivalent (Erythromycin Stearate/Estolate).

• Q: Does it upset the stomach?

  A: Yes. Nausea and stomach cramps are common because Erythromycin stimulates gut motility (it is a “motilin agonist”). Taking it with food helps.

• Q: Can I take it with other meds?

  A: Caution. It is a strong enzyme inhibitor (CYP3A4). It can dangerously increase levels of drugs like Statins, Warfarin, and Theophylline. Always check with a pharmacist.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 250mg to 500mg every 6 hours (4 times a day).

• Severe Infections: Up to 4g daily.

• Acne: 250mg twice daily.

• Administration: Best taken on an empty stomach (1 hour before meals). If GI upset occurs, take with food.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, vomiting, abdominal pain, diarrhea (very common).

• Hepatotoxicity: Rare cases of cholestatic hepatitis (especially with the Estolate form).

• Cardiac: QT Prolongation (risk of arrhythmia). Avoid in patients with heart conditions or those taking other QT-prolonging drugs.

• Interaction: Contraindicated with Simvastatin, Lovastatin, and Ergotamine.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.