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2018/04/16

PharmaBio Nagoya Facility has received a manufacturing license from Ministry of Health, Labor and Welfare (MHLW)

PharmaBio (CEO: Hitoshi Kusano, headquarter: Nagoya City) is delighted to announce that our Nagoya Manufacturing Facility has been received an audit from Pharmaceuticals and Medical Device Agency (PMDA), then a manufacturing license compliant to Act on the Safety of Regenerative Medicine (ASRM) from MHLW on April 5th, 2018 (License Facility Number: FA4170002).

PharmaBio has been offering solutions focused on contract manufacturing of regenerative medical products that are approved or aiming for approval based on the Pharmaceutical and Medical Devices Act (PMD Act). In order to respond to the needs of people who suffer from diseases difficult to treat with conventional medicines, it is essential to expand the number of items of innovative regenerative medical products as a new therapeutic approach. However, there has only been 5 products approved as regenerative medical products in Japan even after regenerative medical products became defined as a new category following pharmaceuticals and medical device in the PMD Act 3 years and 6 months ago. In order to meet the expectations of people waiting for regenerative medical products through an increase in the number of approved items, we came to the idea that it is important to involve in candidate products from the initial R & D stage, which is the preliminary stage of development based on the PMD Act. The acquisition of the manufacturing license in one of our activities to achieve accelerating the increase in the number of approved items of regenerative medical product though support of promising seed clinical research.

PharmaBio strive to contribute to society through regenerative medicine more than ever.

【About PharmaBio】
PharmaBio, as Japan’s first contract development and manufacturing organization for specialized in cell and tissue-derived pharmaceuticals, provides pharmaceutical development solution business and contract manufacturing of cell and tissue based products and which achieves highly quality and high effectiveness in manufacturing development process.
In addition, we will respond to the development manufacturing consignment for Global Study through a service provision alliance with Cell Therapies pty. Ltd., which is known as leading CDMO in the Asia Pacific region in the cell / tissue derived medicine field.

PharmaBio Corporation Administrative division
Yuki Takahashi / +81-3-6205-4101/ hq_kanri@pharmabio.co.jp


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