Sterile APIs
High performance microfiltration
technology
| Archimica sterile API facilities |
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Design
Dissolution, sterilization (filtration), crystallization, drying |
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Reactors
Glass lined and Hastelloy
(from 160 l up to 1800 l) |
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Capacity
Several kilos to 100 mt/year |
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Clean room
Class A or 100 |
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cGMP
Yes (Tonneins: FDA-inspection
June 2007) |
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Experience
More than 15 years
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Archimica is a leading provider of bulk sterile APIs for the pharmaceutical market, offering state-of-the-art technology, broad synthesis capability and a full range of developmental and manufacturing options to meet the specialized needs of a sterile drug commercialization project. In June 2007, our Tonneins site has been successfully inspected by the FDA.
Today, we manufacture bulk sterile APIs to cGMP standards using high performance microfiltration technology at two facilities in southwest France. This capability is complemented by a range of ancillary technologies that ensure aseptic processing of finished pharmaceuticals and offer a range of options for finished product form. Over the past five years, we have delivered thousands of batches of bulk sterile APIs on time without a single quality complaint.
At Archimica, we offer a complete range of synthesis capabilities for sterile API projects – from raw materials through regulated early and late stage intermediates to bulk APIs. We also offer advanced building blocks based on proprietary, leading technologies that can be used in all of these synthesis situations. Our sterilization capability can be integrated with API production or operate as a separate outsourced step for companies that do not have bulk sterile facilities or who may need additional capacity.
For detailed information please click here.
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