We have numerous contract achievements from pharmaceutical companies, universities, and venture companies both domestically and internationally!
Our company is capable of considering injection drug prescriptions and manufacturing clinical trial drugs from the early to mid-development stages. In the summer of 2023, the manufacturing line for clinical trial drugs from early, mid, and late development to commercial production will begin operations at our group company, Iwaki Pharmaceutical Sakuragawa Factory Co., Ltd. We can provide seamless services for pharmaceutical development to commercial manufacturing, including highly pharmacologically active (highly active) drugs. We comply with GMP standards in Japan, the U.S., and Europe, as well as PIC/S GMP, and support supply to global markets, including the Japan-U.S.-Europe triad. Please feel free to contact us when needed. 【Diverse Dosage Forms】 ■ Dosage Forms: Solution formulations, freeze formulations, lyophilized formulations ■ Materials: Glass vials (3-35mL), rubber stoppers/caps (13mm, 20mm) ■ Filling: Solution filling 0.5-20mL/vial *For more details, please refer to the PDF materials or feel free to contact us.
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【Clinical Trial Drug Manufacturing Equipment】 <Containment> ■ High-level containment management ・OEL: 1–0.1μg/m3 (equivalent to exposure management category 5) <Cross-contamination Prevention> ■ Drug preparation – Aseptic filtration – Filling process ・All single-use systems <Equipment> ■ Filling isolator connected equipment （Vial washing and sterilization – Filling and capping – Connecting drying – Cap tightening – Vial external washing） *For more details, please refer to the PDF document or feel free to contact us.
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**Achievements (Excerpt)** ■GMP: Tri-regional GMP for Japan, the US, and Europe, PIC/S ■Drugs handled: Capable of handling high-potency category 5 ■Filling volume: 0.5 to 20 mL ■Rubber stopper/cap sizes: 13 mm, 20 mm ■Inspection: Visual inspection ■Secondary packaging: Boxed packaging, individual packaging, double-blind packaging ■Storage: Refrigerated room (2°C to 8°C), cold storage equipment (-70°C, -20°C) ■Others: Only visual inspection, can also accommodate individual packaging of labels *For more details, please refer to the PDF document or 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.