Capabilities
Manufacturing & CMC
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Manufacturing & CMC
Drawing on NOVARK BIO, which has built up a pharmaceutical business over more than seventy years, we take new drug candidates through manufacturing, CMC and formulation development.
Pharmaceutical Manufacturing & CMC
NOVARK BIO is the pharmaceutical company within the Advalife Science Group, with a record of manufacturing and marketing over-the-counter medicines. It carries forward the know-how and the manufacturing and quality management base built up over many years, and works stage by stage on the CMC questions raised by the new drug candidates Advalife Science is developing — manufacturing process, formulation development, analysis, quality attributes, specifications and stability.
Pharmaceutical Heritage
The name NOVARK BIO is new, but the business it embodies — the manufacturing and marketing of pharmaceutical products — was founded in November 1948 as Yoneda Pharmaceutical Co., Ltd. and has been built up over more than seventy years.This experience and knowledge is fully utilised during the development of new medicines.
Pharmaceutical Manufacturing Infrastructure
MANUFACTURING SITE
A manufacturing and quality management base supporting the manufacture and marketing of existing medicines.
Manufacturing site: 7-6-14 Yumegaoka, Iga-shi, Mie 518-0131, Japan
PHARMACEUTICAL MANUFACTURING
Building on established manufacturing experience, manufacturing, formulation and quality management are carried out according to the characteristics of the product.
CMC DEVELOPMENT
For each new drug candidate, the manufacturing process, formulation, analytical methods, quality attributes, specifications and stability are worked out according to the stage of development, building the CMC foundation for non-clinical and clinical development, and any future application for approval. New formulations, including injectables, are developed step by step, in line with the facilities, licences and quality systems each requires.
GMP & Quality Management
Quality attributes and specifications
The quality attributes, specifications and test methods required are set and managed in the light of the product, the manufacturing process and the development stage.
Quality control and testing
Raw materials, intermediates and finished products undergo the testing and quality evaluation required for pharmaceutical manufacturing and quality management.
GMP documentation and traceability
Procedures, records, changes and deviations relating to manufacturing and quality management are properly controlled, so that the manufacturing process and the quality information remain traceable.
Regulatory Licenses & GMP
NOVARK BIO manufactures under the licences required for the manufacture and marketing of pharmaceutical products, with manufacturing and quality management in accordance with the applicable GMP and other laws and standards.
Manufacturing licence
No. 24AZ200042
Marketing authorisation holder licence (Category II)
No. 27A2X00238
Wholesale distribution licence
No. B10399
GMP is a standard for the control of manufacturing and quality in pharmaceutical products. We do not describe any product as “GMP-certified” or otherwise suggest that a product itself has been certified; what is stated is a manufacturing and quality management system operating in accordance with the applicable GMP.
How this differs from the Shin-Yokohama Facility
NOVARK BIO’s pharmaceutical manufacturing, GMP and CMC base is separate to the manufacture and quality management at the Advalife Science Shin-Yokohama Facility, including its registration as a cell processing centre and its ISO/IEC 17025 accreditation. Each is a separate regime with separate quality management systems. For the Shin-Yokohama Facility, see Quality Management.
CMC Development
CMC is not a separate step. It runs alongside research, non-clinical work and clinical development, and is continually re-evaluated. The CMC work carried out follows the nature of each programme, the data obtained, the development stage and the regulatory requirements.
Enquiries about manufacturing and CMC
We welcome enquiries about pharmaceutical manufacturing, formulation and CMC development, quality management and co-development.