Frequently Asked Questions

Inquiries & Quotations

QWhat information is required to make an inquiry?

AFor custom manufacturing inquiries, please provide information specifying the target compound (chemical structure, name, CAS number) or processing conditions. We can provide a more accurate quotation if literature or a synthesis recipe is available.

QHow long does it take to receive a quotation?

ATypically, we can submit a quotation for custom manufacturing in as little as two weeks from your inquiry. This can be further shortened if you provide your manufacturing track record.

QCan I make an inquiry for compounds without a CAS number or with no manufacturing track record?

AYes. Even without a CAS number, we will evaluate the synthetic route based on a literature review and provide a quotation for custom manufacturing. We will also conduct a desk study if necessary.

QDo you handle only small-batch production or pilot production?

AWe specialize in custom manufacturing at the 20 L to 15,000 L scale. As a general rule, we do not accept requests exclusively for one-off, small-batch or pilot production. However, if there are plans for future scale-up or commercial production, we can accommodate laboratory-scale sample synthesis and small-batch production. Technical meetings are also available.

Questions about Manufacturing & Technology for Custom Manufacturing

QIs it possible to request custom manufacturing exclusively for pilot production or small-batch production?

AAs a general rule, we do not accept requests exclusively for one-off, small-batch custom manufacturing. However, we can accommodate such requests if there are plans for future scale-up or commercial production.

QCan I request Process Development as a standalone service?

AWe do not accept requests exclusively for Process Development, but we can provide comprehensive support as a custom manufacturing project with a view to commercial production.

QDo you support Scale-Up?

AYes, scale-up in custom manufacturing is our specialty. We can handle everything from laboratory scale to plant scale with high quality and short lead times.

QI would like to improve the manufacturing process during scale-up. Can I request this as part of custom manufacturing?

AYes, it is possible. Our in-house development department conducts development of new synthetic routes, and we can also support improvements in quality, yield, and productivity (throughput).

QDo you support manufacturing under CGMP Control?

AYes. We support CGMP-compliant custom manufacturing. Utilizing our kilo labs and dedicated plants, we have a proven track record in manufacturing investigational APIs and passing FDA inspections.

Questions about Contracts, Regulatory Compliance & Intellectual Property for Custom Manufacturing

QHow do you handle information disclosure, confidentiality, and information management?

AWe will execute a Non-Disclosure Agreement (NDA) upon request. Furthermore, we strictly manage all information provided to us.

QDo you claim ownership of industrial/intellectual property rights?

AAs a general rule, intellectual property rights for the deliverables of custom manufacturing belong to the client. Individual discussions may be required depending on the specific details.

QDo you support Regulatory Compliance (e.g., Chemical Substances Control Law, PMD Act)?

AYes, we have a proven track record in Regulatory Compliance for custom manufacturing projects, and we have a system in place to comply with the Chemical Substances Control Law, REACH, the PMD Act, and others.

Questions about Organization & Other Support for Custom Manufacturing

QCan you prepare documents such as SDSs and specifications?

AYes, we can prepare various documents, including specifications, SDSs (Safety Data Sheets) for compounds, and BSE/TSE certificates.

QCan I receive a report after the custom manufacturing is completed?

AYes. Upon request, we will prepare and submit a report detailing the synthesis.

QIs it possible to tour the plant during the consultation?

AYes, it is possible. You can visit us and tour our plant facilities. Please contact us in advance.