Contract Manufacturing

Okayama Plant Gunma Plant

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

Okayama Plant

In addition to the preparation facility that began full operations in 2009, we aim to establish a foundation as a 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

Gunma Plant

Gunma Plant provides development based on technical capabilities and knowledge cultivated over many years

In addition to contract manufacturing of ethical and over-the-counter pharmaceuticals, at our Gunma Plant we provide a wide range of services from the early development stage, including formulation design, investigational drug manufacturing, and analytical method development, to the preparation of application materials and support for obtaining regulatory approval. We also collaborate with each of our other plants to provide the most beneficial services to our customers.

Plant Overview

Production surpasses the standards of stable supply, quality, cost, speed, and technology required for contract manufacturing of pharmaceuticals.

    • January 2020
      ・ New warehouse building begins operation.
      Standard warehouse (15-25℃): 1600 pallets
      Refrigerated warehouse (2-8℃): 50 pallets
      ・ LIMS begins operation.
    • August 2020
      ・ Launch of serialization services for the global market.
    • December 2021
      ・ Introduction of inductively coupled plasma mass spectrometry (ICP-MS) for elemental impurity analysis.
    • April 2022
      ・ Manufacturing execution system (MES) begins operation.

      Site area: 57,885 m2
      Gross floor area (plant): 30,360 m2
      Area composition: Warehousing, synthesis, formulation, filling and packaging, quality control technology, administration, training

Contract manufacturing capacity/capability

The Gunma Plant possess manufacturing facilities that can handle a wide variety of dosage forms in oral and topical formulations. We are capable of receiving orders to manufacture products by request, from investigational drugs to commercial production. We have built relationships of trust with major pharmaceutical companies in Japan and overseas, and have a proven track record of manufacturing products while ensuring high quality.

Dosage Forms Production (annual)
Tablets Uncoated tablets, wet tablets®, OD tablets, sugar-coated tablets, film-coated tablets, cored tablets, laminated tablets 2 billion tablets
Capsules Hard capsules
Liquids Double-formed packaging, PE containers, glass containers 150 tons
Ointments Jar containers, tubes 1100 tons
Granules/dispersions (including food and chemical products) 350 tons

  • Development department and a wide range of prototyping equipment to meet customer needs

    The Gunma Factory has a development department (CMC Development Department) to provide formulation and packaging technologies to meet customer needs. We have an extensive lineup of prototype machines and establish optimal manufacturing methods from small-scale prototype production. We also have an extensive GMP backup system and are committed to high-level quality assurance.