CDMO Services
We support the creation of safe and secure
medicines through our cGMP-compliant
manufacturing system.
medicines through our cGMP-compliant
manufacturing system.
Service Overview
Drawing on over 70 years of experience and high level of expertise as a leading supplier of antibacterial agents, we provide one-stop support from formulation and/or manufacturing process development to commercial production.
- Contract manufacturing services
- Formulation and/or manufacturing process development
- Scale-up study / PV production of actual equipment
- Formulation
- Packaging
- Shipping
- Contracted pharmaceutical products
- General oral solid forms
- Vial injection (liquid, lyophilized)
- Syringe Injection (glass, plastic)
- Sterile powder formulation
- Biological preparations
- β-lactam oral formulations (in a dedicated production area). For cephem and carbapenem antibiotics, we have dedicated manufacturing areas.
Characteristics and Strengths
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Advanced containment measures
- We strive to gain a deeply understanding of our customers' strategic goals and product supply aspirations, and with our flexible production system, we can propose long-term solutions that benefit our customers
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Sterile drug products manufacturing experience and responsiveness
- In our sterile manufacturing area, we have a track record of supplying 7 million units per year and can flexibly respond to pilot-scale manufacturing. We also have a proven track record of manufacturing and supplying new modalities, such as vaccines.
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Global supply chain know-how
- As a member of Meiji Seika Pharma Group, we have played a role in the global supply chain and cultivated our own expertise in global procurement management.
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More than 30 years of domestic supply track record
- With over 30 years of experience, we have a proven track record of supplying products in Japan under strict quality standards, ensuring the delivery of reliable pharmaceuticals.
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Quality assurance and compliance with delivery dates
- In addition to quality compliance, we prioritize customer-focused employee training. Because of this approach, we are strongly committed to on-time delivery, and our team works together to meet deadlines, even in challenging situations.
Service Menu by Product
Sterile Drug Products
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We provide products that meet our clients' needs through our proven technical expertise and comprehensive sterility assurance system.
Tablets/Fine Granules
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We meet a wide range of manufacturing requirements, from small to large scale production, with strict controls from our MES system.
β-lactam Antibiotics
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We provide contract manufacturing services of β-lactam Antibiotics in advanced containment areas.
Analysis Service
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In addition to contract manufacturing, we also conduct various quality tests essential for pharmaceutical quality control.
Contract Manufacturing Flow
Hearing of customers’ needs
We strive to gain a deeply understanding of our customers' strategic goals and product supply aspirations, and with our flexible production system, we can propose long-term solutions that benefit our customers
Proposal for formulation, manufacturing process development, and contract manufacturing services.
As a leading supplier of antibacterial agents, we have the experience of overcoming numerous technical hurdles and successfully commercialize our products.
We start by listening to our customers’ needs and use our advanced expertise to proactively identify potential risks. This allows us to propose solutions that ensure the success of their pharmaceutical manufacturing, all while staying on schedule with the development plan.
We start by listening to our customers’ needs and use our advanced expertise to proactively identify potential risks. This allows us to propose solutions that ensure the success of their pharmaceutical manufacturing, all while staying on schedule with the development plan.
Formulation and/or manufacturing process development / Prototype production / Process validation (PV) manufacturing
We have established a cross-departmental project management system to ensure a solid development plan, from technology transfer to process development and evaluation.
By working together as a team and responding with speed and flexibly, we have built a strong track record of achievements.
Additionally, our staff, who are highly knowledgeable about our facilities, can provide flexible troubleshooting support to ensure a smooth start to commercial production.
By working together as a team and responding with speed and flexibly, we have built a strong track record of achievements.
Additionally, our staff, who are highly knowledgeable about our facilities, can provide flexible troubleshooting support to ensure a smooth start to commercial production.
Commercial production (shipping)
We comply with the current regulations, never compromising on quality. We strive to achieve high-quality compliance and always aim to provide our customers with the highest quality products.
In addition, all employees are deeply committed to a “customer first” approach. We are also flexible enough to respond to changes in production plans etc., allowing us to supply high-quality pharmaceuticals to as many patients as possible in a timely manner.
In addition, all employees are deeply committed to a “customer first” approach. We are also flexible enough to respond to changes in production plans etc., allowing us to supply high-quality pharmaceuticals to as many patients as possible in a timely manner.
Frequently Asked Questions
FAQ
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How do you manage the quality of your products?
- We use Manufacturing Execution System (MES), Laboratory Information Management System (LIMS) and Quality management system (QMS).
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Are there any restrictions on the contract manufacturing quantity?
- The amount of contract manufacturing depends on the product's type and specifications. Please contact us for more details.
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Do you handle highly pharmacologically active ingredients?
- We have manufacturing experience up to OEL category 4. Please contact us to discuss the contract manufacturing of highly pharmacologically active ingredients that require containment.
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Is it possible to outsource the manufacturing of only the packaging process?
- It is possible.
Inquiries about Our Business Activities
For details about our CDMO Services, please contact our dedicated
CMO business email address.
CMO business email address.
Meiji Seika Pharmatech Co., Ltd. Technical Department
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- CDMO Services