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Contract Limit of Product

For some formulations, as shown in the table below, we set limits as contract subject.

Category Existing plant Investigational
product plant
Quality
test
Storage
Manufacturing Packaging test Manufacturing Packaging test
Antibiotics Penicillin &
Cephem Group
× × × × × × × ×
Others × × ×
Hormones
(steroids, prostaglandin etc.)
× × ×
Aniticancer agents
(cell toxicity mechanism)
× × × ×
Anticancer agents :
LD50<50mg(p.o.)
× × × ×
  • ○ : services available × : services not available
  • ※ “Packing”above is secondary packaging. See the “Manufacturing” boxes for primary pacckaging services.
  • ※ The handling of the “anti-cancer agents (cytotoxic mechanism)” and “category of anti-cancer agent” in investigational drug testing building is subject to our standards specified otherwise.
  • ※ Even a substance not listed in the table above, we may not contract by our standards specified otherwise.

Contract Details

  • 1.Product name, development code, SDS
  • 2.Ingredients, dose, raw materials
  • 3 Manufacturing methods
    1. Outline and scope of contract manufacturing 2. Scale and number of lots
  • 4 Outline of specifications and test methods, and scope of contract testing
    Testing requirements, specifications, test methods
  • 5.Storage conditions, expiration date
  • 6.Expected indication and efficacy / intended purpose
    Intended purpose: non clinical trials / clinical trials (Phase-I, Phase-II, Phase-III)
    Inside or outside of Japan
  • ※The above is a basic set of data we need for contract services.
    Please note that not all the pieces of data above are necessary depending on the types of contract services you need and the developmental stage where your product is in.

Flow of Contract Services

Inquiry

Confidentiality agreement signed

Technical information transfered, SDS disclosed

Preliminary cost estimates
(Rough estimation may be given at the time of inquiry)

Drawing up a writen agreement
upon agreement on the cost and schedule, a written agreement is drawn up.