Azithromycin Tablets Manufacturer India

What We Manufacture

Azithromycin Tablet — specifications & clinical context

Product Specifications

Generic Name	Azithromycin Dihydrate
Strength / Dosage	250mg · 500mg
Dosage Form	Film-Coated Tablet
Route of Administration	Oral
Pack Size	Strip of 3 · Strip of 5 · Strip of 6
Packaging	Alu-PVC blister · Alu-Alu blister
Storage	Store below 30°C · Protect from moisture
Shelf Life	24 months
Manufacturing Facility	WHO-GMP Certified · Birkoni, Chhattisgarh
Regulatory Status	DCGI Approved · Manufacturing Licence Held
Available For	Contract manufacturing · Third-party manufacturing · Direct institutional supply

Clinical Context

Azithromycin is the most prescribed macrolide antibiotic globally — on the WHO Essential Medicines List. The 3-day 500mg course for community-acquired pneumonia and atypical respiratory infections drives enormous prescription volume. Also widely used for STIs (Chlamydia single 1g dose), skin infections and typhoid. During COVID-19, Azithromycin prescriptions surged significantly in India and African markets — demonstrating the volume sensitivity to respiratory disease burden.

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Why 9M India

How Azithromycin Tablet is manufactured at 9M India

WHO-GMP certified manufacturing process

Azithromycin tablets are manufactured through wet granulation with optimised coating to mask the extremely bitter taste of Azithromycin API. Film coating is critical — both for taste masking and stability. Validated coating weight gain of 3–5% confirmed with in-process weight monitoring on every batch.
In-house QC release testing — every batch

Dissolution (>80% in 45 min) · Assay by HPLC · Related substances (azithromycin impurities A–N per EP/IP) · Content uniformity · Microbial limits — all in-house. COA per batch.
Complete documentation within 24 hours

Manufacturing Licence · DCGI product approvals · WHO-GMP Certificate · Certificate of Analysis · Certificate of Conformance · Stability data (real-time and accelerated, ICH-aligned) — pre-prepared and available within 24 hours for tender submission, export registration or contract manufacturing due diligence.