Amoxicillin Tablets Manufacturer India

What We Manufacture

Amoxicillin Tablet — specifications & clinical context

Product Specifications

Generic Name	Amoxicillin Trihydrate
Strength / Dosage	250mg · 500mg
Dosage Form	Hard Gelatin Capsule · Tablet
Route of Administration	Oral
Pack Size	Strip of 10 · Bottle of 500
Packaging	Alu-PVC blister · Strip packing · HDPE bottle
Storage	Store below 25°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

Amoxicillin is the most widely prescribed antibiotic globally — on the WHO Essential Medicines List and the highest-volume antibiotic in government pharmaceutical tenders in India and across Africa, South-East Asia and the Middle East. Indicated for respiratory tract infections, ear-nose-throat infections, urinary tract infections and skin infections. 9M India manufactures from a dedicated beta-lactam facility — essential for cross-contamination prevention and regulatory compliance.

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Why 9M India

How Amoxicillin Tablet is manufactured at 9M India

WHO-GMP certified manufacturing process

Amoxicillin capsules and tablets are manufactured in a dedicated beta-lactam manufacturing area — completely separated from non-beta-lactam areas with dedicated equipment, HVAC and personnel flow. Validated environmental monitoring programme for beta-lactam particles. Amoxicillin is moisture-sensitive — all manufacturing under controlled humidity (<40% RH) with Alu-Alu or Alu-PVC moisture-barrier packaging.
In-house QC release testing — every batch

Dissolution (>80% in 60 min) · Assay by HPLC (95.0–102.0%) · Related substances (including penicilloic acids) · Content uniformity · Water content by Karl Fischer · 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.