Spectrum Pharmaceuticals, Inc announced last month the approval to market Levoleucovorin for Injection from the US Food and Drug Administration (FDA). Approval was granted after the FDA reviewed application submissions supported by data from BioScreen Testing Services, Inc.
BioScreen provides contract testing services to companies large and small and has contributed data to support many submissions to the FDA resulting in approval.
"We offer our sincere congratulations to Spectrum," said Bradford Rope, President of BioScreen Testing Services, Inc. "BioScreen looks forward to a continuing partnership, providing release testing support during the manufacture of Levoleucovorin, as well as additional development support for the many drugs in Spectrum's pipeline."
More information regarding Spectrum Pharmaceuticals Inc. can be found at
www.spectrumpharm.com.
The method validation study for Levo- leucovorin for Injection was presented by BioScreen and Spectrum at the poster session held at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting at the San Diego Convention Center in November 2007.
About BioScreen Testing Services
BioScreen Testing Services is a quality-driven contract laboratory providing analytical chemistry, microbiology and stability services to the pharmaceutical, biotechnology, medical device and personal care industries. The Pharmaceutical Division is staffed with scientists that specialize in method development, validation, compendial testing and contract research. BioScreen is FDA and DEA registered, and ISO 9001:2000 certified. The company complies with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
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