Contract Manufacturing

Okayama Plant

Contract manufacturing of pharmaceutical products is a new business area for Alfresa Pharma.

In addition to the preparation facility that began full operations in 2009, we aim to establish a foundation asa commissioned manufacturing business with a new packaging facility that conforms to GMP requirement sand is scheduled to begin operations in January 2014. At present, we are conducting contract manufacturing of solid and liquid agents in standard sizes from 5 mL to 500 mL for domestic and foreign pharmaceutical manufacturers. For liquid agents, we are capable of aseptic filling from glass containers to PE containers,and we also support systematic packaging from paper cases to shrink labeling and shrink film packaging.In addition, we also support plug and cap containers as well as pump reservoirs.
In solid agents, mainly sugar coated tablets, we are moving to high-efficiency production conforming to proper scale and sanitary containment standards. We are also introducing new dosage forms and manufacturing methods to increase our contract manufacturing performance.

Our strengths in liquid/solid agents

Liquid Agents

  • Aseptic filling from glass to PE containers
  • Supports 5-to-500 mL containers
  • Consistent packaging support (paper casing, shrink labeling,
    shrink film packaging, etc.)
  • Capability in internal plugs, cap containers and pump reservoirs
  • Manufacturing using first and second-grade petroleum products

Solid agents(mainly sugarcoated tablets)

  • Hygienic (containment), effective production (to proper scale)
  • FC machines with broad production scale (flexible sugarcoatedtablets, FC tablets to irregular shaped tablets)
  • Actions to achieve new dosage forms and manufacturing methodsin the future

(Four rooms set aside to future needs)

Commissioned formulation possibilities

We use the following process for dosage forms in commission formulations.

Dosage Form Manufacturing Process
SolidAgents Tablets Weighing, Granulation/Tableting, Sugarcoating, Printing, Inspection, Packaging, Display
Liquid Agents Internal Use Liquid Agents
(Aseptic Filling Possible)
Weighing, Dissolution, Filtering, Plugging, Packaging, Display
External Use Solid Agents Weighing, Dissolution, Filtering, Plugging, Packaging, Display

Production capacity

Manufacturing capacity, including near-future capital investment

Dosage Form Accommodated Items Manufacturing Capacity/Year
Solid Agents Tablets Uncoated Tablets 600 million
Sugar/Film-Coated Tablets 1 billion
Liquid Agents Internal Use Liquid Agents 30-500mL 3 million
5-50mL 14 million (10 mL capacity)
External Use Liquid Agents 5-500mL More than 1 million

Liquid Agents facilities

Liquiid Agents B line

Preparation 2t/5t tanks

Container cleaning, drying,
sterilization equipment

Filling machine (30-500ml)

Packaging equipment

Liquiid Agents D line

Filling machine (5-50ml)

Packaging equipment

Solid agent facilities 1

High-speed tableting machine

Coating machine

Automatic tablet inspection machine

Solid agent facilities 2

Liquid agents
Nine contract manufacturing customers (two foreign customers)
10mL (PE container)*grade 1 petroleum products - 1.25 million
10mL (PE container)- 6.2 million
120mL (PE container)- 480,000
500mL (PE container)- 150,000
Other
30mL/100mL/250mL/500mL (glass container) - 200,000
Solid agents
Five contract manufacturing customers (two foreign customers)
Tablets (uncoated tablets, sugarcoated tablets, film-coated tablets) - 80 million
Dry syrup, granules, powders