Commercial Scale
Freedom to Operate – Solid phase custom manufacture

First and foremost, Girindus has executed license agreements that give us the freedom to operate solid phase oligonucleotide manufacturing processes utilizing technologies covered under certain patents. The licenses cover key steps in the manufacturing processes to be used in the manufacture of all major classes of oligonucleotides (including the steps of detritylation, activation of phosphoramidites, sulfurization […]

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Commercial Scale
FDA Inspection

Following our registration with FDA as API supplier [for both oligonucleotides and small molecules], Girindus received unannounced systems audits by the FDA in 2007 and in 2010. The audits included small molecule and oligonucleotide manufacturing areas. The results were exemplary:  no form 483 and no objectionable findings.   Our FDA registration number is: 3003270485 For detailed […]

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Quality
CMC Documentation

Our QA team has over 50 years of cumulative experience, with a proven compliance record in the pharmaceutical industry and can support clients with CMC, DMF and IND submissions. For additional information, please contact our project management team.

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Quality
Quality and Compliance

Excellent Compliance Track Record –  The compliance track record at our facility in Cincinnati, Ohio, USA is excellent, demonstrated by numerous successful inspections by FDA and by our customers.  Following our registration with FDA as API supplier [for both oligonucleotides and small molecules], Girindus received in 2007 and 2010 unannounced systems audits by the FDA that […]

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Communication
Project Management

Our experienced project management team is led by a PhD chemist with 10 years of pharma experience in analytical development, quality control and manufacturing. The team is comprised of chemists and chemical engineers with experience in managing complex, multi faceted projects with aggressive timelines.  Flexibility - We understand the need to be flexible in early phase […]

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Products & Services
Small Molecules

We offer our clients a broad range of synthesis and services for the development of small molecules / NCE through the early pre-clinical stages up to the commercialization of the API for volumes of 100’s of grams to 10’s of kilograms. We also have access to a full scale multipurpose cGMP production facility in Giraud, […]

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Products & Services
Radiolabeling

Our site in Cincinnati provides 1000 square-foot laboratory dedicated to "cold" development chemistry and four dedicated individual radiochemistry cells.  Various analytical tools such as radio- TLC, HPLC, PDA’s, in-line radioactive flow cells, NMR and scintillation counting are available to analyze and release your radiolabeled products. We hold licenses for the use of carbon-14, tritium and iodine-125.  […]

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Products & Services
Oligonucleotides

As a customer-driven company we offer our pharmaceutical clients comprehensive skills, ranging from process development, analytical method development, radiolabeling, cGMP compliant scale-up and manufacturing of active ingredients, as well as regulatory support.  We can provide oligo’s at scales from 10’s of mg to kilos for applications from pre-clinical research and toxicology studies to clinical trials […]

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