AmgenCapsule

About AmgenCapsule

Leading Manufacturer of Pharmaceutical Capsules in Thailand

Company Profile

AmgenCapsule is a leading manufacturer of pharmaceutical capsules based in Thailand. We specialize in producing high-quality empty capsules including HPMC (plant-based), gelatin, halal, and enteric capsules.

Our Facilities

  • Location: Thailand
  • Production Area: ~20,000 m² construction area
  • Clean Workshop: ~5,000 m²
  • QA/QC Area: ~500 m²
  • Annual Capacity: Up to 10 billion hard empty capsules
  • Standards: GMP certified

Our Markets

Our products are sold in China and exported to Europe, the US, and Southeast Asia.

We have been designated by China's State Oceanic Administration (SOA) as a R&D base for marine products, cooperating with Zhejiang Wanli University on plant-based (marine) hollow capsules and plant enteric capsules.

GMP Production Workshop

Our purification workshop is fully enclosed with constant temperature & humidity, featuring:

GMP Production Environment
Clean Production Environment
GMP Workshop Facilities
GMP Certified Workshop

🌡️ Climate Control

Central HVAC system for optimal production conditions

🔬 Quality Testing

High-tech detection for each production step

🎨 Printing Options

Monochrome, two-color, axial, ring, and directional printing

📋 Full Documentation

Comprehensive batch records and QA monitoring

Our Advanced Production Process

Every capsule goes through our rigorous, multi-stage production process, ensuring the highest quality standards from raw materials to finished products. Our state-of-the-art facilities combine traditional expertise with modern technology to deliver exceptional results.

Production Line

State-of-the-Art Automated Production Line

01

Raw Material Selection & Verification

We source premium materials exclusively from certified suppliers worldwide. Every batch undergoes rigorous incoming inspection including:

  • Certificate of Analysis (CoA) verification
  • Microbiological testing
  • Heavy metals and residual testing
  • Identity and purity confirmation

🎯 Result: Guaranteed material quality, traceability, and compliance with international standards

02

Gelatin Melting & Colorization

Our advanced melting tanks maintain precise temperature control (±0.5°C) to ensure optimal viscosity. Color matching uses pharmaceutical-grade pigments with:

  • Automated color dosing systems
  • Real-time viscosity monitoring
  • Multi-point temperature control
  • Batch-to-batch color consistency checks

🎯 Result: Perfect color uniformity and formulation stability

03

Precision Capsule Forming

Our automated capsule machines operate 24/7 with advanced process controls:

  • High-speed forming (up to 150,000 capsules/hour per line)
  • Precision dimensional control (±0.02mm)
  • Automated quality checks at 100% inspection rate
  • Real-time thickness and moisture monitoring

🎯 Result: Consistent dimensions, perfect sealing, zero defects

04

Printing & Custom Branding

Our printing department offers unlimited customization options:

  • High-resolution logo and text printing
  • Multiple colors and print patterns (monochrome, two-color, axial, ring, directional)
  • FDA-approved printing inks
  • Full batch traceability codes

🎯 Result: Professional branding, brand protection, and product identification

05

Comprehensive Quality Control

Every batch undergoes extensive testing in our certified QA/QC laboratory:

  • Physical testing: length, width, weight, moisture content
  • Disintegration time testing (USP/EP methods)
  • Dissolution testing for enteric capsules
  • Microbiological testing (TAMC, TYMC)
  • Heavy metals and residual solvent analysis

🎯 Result: 100% compliance, batch release certification, zero recalls

06

Automated Packaging & Labeling

Final packaging ensures product integrity and regulatory compliance:

  • Automated counting and filling systems
  • Tamper-evident packaging
  • Barcode and QR code labeling
  • Compliance with international packaging standards
  • Custom packaging formats available

🎯 Result: Safe storage, easy tracking, ready for distribution

Production Capacity & Capabilities

10+ Billion
Capsules Per Year
24/7
Production Operation
99.9%
Quality Pass Rate
150K+
Capsules/Hour Per Line

Capsule Origin & Development

The history of pharmaceutical capsules spans centuries of innovation:

1500 BC — Early capsules appear in Egypt
1730 — Viennese pharmacists hand-make capsules / early machines
1834 — Capsule manufacturing patented in Paris
1846 — Two-section hard capsules patented in France
1872 — First capsule filling machine in France
1874 — Industrialization in Detroit; size variants emerge
1888 / 1931 — Parke-Davis patents and pushes output to 10k/hour
1946 — First "drug shell" capsule manufactured in China
Today — Continuous innovation toward quality and efficiency

Quality Control & Assurance

We maintain strict quality standards throughout our production process:

Quality Monitoring

  • QA monitors the full production process
  • Routine stability checks on raw materials
  • Comprehensive testing of finished goods
  • Qualified Person system ensures compliance
  • Only conforming lots are released based on batch records

Standards Compliance

  • GMP (Good Manufacturing Practice) certified
  • USP/EP/ChP standards
  • Halal and Kosher certification ready
  • International quality standards