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Pharmalucence offers contract and private-label manufacturing services to those requiring fully validated, aseptic processing for pharmaceutical diagnostic and therapeutic products. We specialize in small batches and partner with our clients bringing the experience and infrastructure established to produce the Pharmalucence catalog of human injectables. Our approach to contract production is uniquely collaborative and driven for your success. Pharmalucence clients include biotech start-ups to "Big Pharma" requiring pre-clinical, clinical and commercial production. Contact us to discuss your program. |
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Aseptic Fill and Finish Services
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Pharmalucence is FDA approved to produce both aseptic and terminally sterilized small volume parenteral products.
We have the capability to produce liquid and lyophilized (freeze-dried) products.
Pharmalucence can manufacture liquid and lyophilized products in batch sizes of 100 to 40,000 vials. Our fully automated filling lines accommodate vials from 2cc to 20cc. Our manufacturing and testing groups are supported by a comprehensive Quality System to ensure that all products are produced in a consistent and compliant manner.
- Cleanroom suite for the production of liquid aseptic and terminally sterilized parenteral products
- Cleanroom suites for the production of aseptic lyophilized parenteral products
- Product Development Laboratory
- Quality Control Analytical Chemistry laboratory
- Quality Control area for testing for radioactive products
- Quality Control Microbiology laboratory
- Labeling and packaging areas
- Stability Sample/Retain storage areas
- GMP medical device manufacturing and storage areas
- GMP medical device Quality Control laboratory
- GMP warehouse
- Raw materials receiving and Quality Control inspection areas
- GMP manufacturing area for radioactive products
- Radioactive material possession license
- Shipping and distribution area for radioactive products
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Formulation Services
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The Pharmalucence Development team will work with your organization to assist advancement of your product formulations from early stage to commercial grade. Team with us to develop and validate analytical methods, liquid or lyophilized formulations, commercially robust production processes and product stability testing under ICH conditions.
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| Created by Red Brick Design |
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