β-lactam Oral Antibiotics
Manufacturing

We provide contract manufacturing
services of βｰlactam oral antibiotics in advanced
containment areas.

Service Overview

We provide contract manufacturing of oral β-lactam Antibiotics that require advanced containment. Based our extensive experience as a top supplier of antimicrobial agents, we offer flexible manufacturing solutions and provide comprehensive support for rapid technology transfer. We also support the timely transition to commercial production by leveraging our superior operability and outstanding expertise to ensure the success of formulation and manufacturing condition studies.　

Characteristics

Key features of reliable containment area

Manufacture of oral β-lactam drug products with advanced containment: Due to their high sensitization potential, we manufacture β-lactam oral formulations that require advanced containment measures.
Zoning design and strict monitoring system: We have incorporated appropriate zoning and airflow design in the manufacturing area, and have implemented a monitoring system to strictly control optimal temperature, humidity, cleanliness, and pressure differential.
Response by specialist workers: In addition to manufacturing, the maintenance and management of the area—including cleaning, sterilization, monitoring, inspection, and other operations—are appropriately handled by workers with specialized education and training.
Efforts to reduce pollution risk: By utilizing equipment with high cleanability and implementing sterilization methods, we have reduced the risk of microbial contamination from equipment.
Additionally, thorough microbiological control training for staff helps further minimize contamination risks during operations.
Compliance assessment for European EHS auditing: We have also received compliance assessments from EHS consultants in accordance with European standards.

Available Manufacturing and Development Support

We undertake contract manufacturing of cephalosporins and carbapenems.
We will find a flexible solution. Please contact us for information regarding the contract quantity.

MES (Manufacturing Control System) is used to centrally control the manufacturing process and ensure thorough quality control.

Process	Building No. 2	Building No. 7
Crushing, Screening, Granulation	Pin mill (1), Pulverizer (1), Comil (3), Vibrating screen (1)	Hammer mill (2), Comil (2), Vibrating screen (2)
Granulating	Tumbling fluidized bed granulation dryer (2)	Mixing granulator (1), Fluidized bed granulation dryer (1), Tumbling fluidized bed granulation dryer (1)
Mixing	Bohle container mixer 1000L (1)	Bohle container mixer 800L (1)
Tableting	ー	24 stations rotary tableting machine (1)
Coating	ー	Vented pan coater (1)
Visual Inspection	Tablet Visual Inspection machine (1), Granule inspection machine (1)	Granule inspection machine (1)
Tablet Printing	Ink printing machine (1)	ー
Packaging	Mid-speed PTP filling line (1), Granule packaging filling device (1), Bottle filling machine (1)	Granule filling machine (1), Bottle filling machine (1)