The selection of starting materials significantly impacts the manufacturing cost of active pharmaceutical ingredients. We would like to introduce our management strategy for starting materials in active pharmaceutical ingredient production.
The selection of starting materials (hereinafter referred to as starting materials) for applications is proposed by pharmaceutical companies in accordance with the general principles of ICH guideline Q11, but it is often the case that they receive frequent inquiries from authorities before approval. At SpiraPharma, when selecting starting materials, organic chemists and analytical chemists collaborate to propose which compounds are suitable as starting materials based on the manufacturing process. Additionally, when establishing management strategies for starting materials, we can obtain data to support responses to authorities through investigations of the behavior of key related substances. For our customers who are challenging the creation of new pharmaceuticals, we will continue to leverage our cultivated technology and experience while furthering our expertise. *For more detailed information on the column, please refer to the related link. For further inquiries, please feel free to contact us.
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Our company is a pharmaceutical CMC research and development contract company that spun out from the CMC research division of Takeda Pharmaceutical Company Limited in July 2017. We support excellent pharmaceutical development as experts in CMC research. Our research team consists of experts with extensive experience and achievements in process chemistry, formulation research and development, and analytical testing development related to CMC research. We provide high-level services and solutions tailored to our customers' needs across each process from the early stages of pharmaceutical development to application, while flexibly collaborating. We have established a collaborative system with partner companies, enabling us to offer a one-stop service. Please utilize us as a platform for your pharmaceutical development.