Contract Manufacturing Contract Manufacturing

Contract Manufacturing Contract Manufacturing

Outline

With our solid formulation technologies and reliable quality assurance, as well as with our management system that meets the domestic GMP and overseas standards, we have established a high-quality and low-cost production system that is consistent throughout the entire processes from the procurement of raw materials, weighing, dispensing, filling, packaging, to shipping.

With our state-of-the-art facilities, we have a flexible production system such as a diversified small-quantity manufacturing and an investigational new drug manufacturing that can be tailored to the needs of customers.

Contract manufacturing services

Ethical drugs, investigational new drugs, over-the-counter drugs, quasi drugs, and development and improvement of each drug formulation

Available dosage forms

Eye drops, ointments/creams, gels, liquid medicines, transdermal patches, cataplasms, tablets, granules, capsules, powders, and health drinks

Outline

Transfer of technology
  • Optimization of manufacturing conditions
  • Optimization of designing drug formulations
  • Optimization of package specifications (a partial outsourcing is available as well.)

Development and improvement of drug formulations
  • Optimization of drug formulations
  • Optimization of manufacturing conditions
  • Optimization of testing methods
  • Pharmacological studies (pharmacokinetic studies)
  • Stability tests

Flow of a contract manufacturing

1.Receive a contract offer from a consignor
▶We confirm the details about product summary and production volume provided by the consignor.

2.Provide a rough estimate
▶We provide a rough estimate based on the contract manufacturing request.

3.Sign a confidentiality agreement, and receive technical data from the consignor
▶We sign a confidentiality agreement with the consignor and check the technical data for manufacturing (production method, production management, quality control, etc.).

4.Plan a contract manufacturing (necessary facilities, labor hours, etc. for the contract) and provide an official quote
▶We investigate necessary facilities, labor hours, etc. for the contract manufacturing based on the technical data and provide an official quote.

5.Sign a contract manufacturing agreement
▶We sign a contract manufacturing agreement with the consignor.

6.Transfer technology
▶The consignor transfers its technology such as production method, analytical test method to us.
In the case where there is any difference in production facilities, production scale, etc., we investigate necessary technology as well.

7.Deal with pharmaceutical regulatory matters
▶We conduct validation and deal with the GMP compliance inspection necessary for a partial change approval application, a minor changes notification, etc.

8.Start a contract manufacturing
▶When the pharmaceutical regulatory matters are completed, the contract manufacturing starts at our company.