Metrics Contract Services Completes ANVISA Regulatory Inspection
Metrics Contract Services, a division of Mayne Pharma, recently announced its Greenville, NC, facility has successfully completed an inspection by the Agência Nacional de Vigilância Sanitária, or the Brazilian National Health Surveillance Agency (ANVISA), for commercial manufacture of a branded oncology drug to be marketed in Brazil. This is the fourth international inspection to evaluate the 126,000-sq-ft commercial manufacturing facility completed in 2018.
With this satisfactory inspection, Metrics Contract Services now has GMP approvable inspections by the US FDA, the Japanese PMDA, the Turkish Ministry of Health, the Russian Federation, and the Brazilian National Health Surveillance Agency.
Mayne Pharma President John Ross said “Successfully completing an audit to Brazilian GMP standards is an important milestone on our journey to provide a comprehensive offering to clients from initial concept to global commercial supply in oral solid dose.”
The recent 5-day audit examined numerous areas, including Utilities, Validation, Quality Control, Operations, Quality Assurance and Supply Chain. According to Ross, the favorable outcome from this inspection “reflects our commitment to always improving our quality systems and processes to satisfy a global regulatory standard.”
Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization serving clients worldwide delivering proven scientific and operational excellence for novel oral dosage forms. Metrics’ areas of expertise include quality pharmaceutical formulation development; first-time-in-human formulations; Phase 1-3 clinical trial materials manufacturing; and analytical method development and validation services leading to commercial scale manufacturing. Technical capabilities include highly potent, cytotoxic and unstable compounds; Schedule II-V controlled substances; and products with poor bioavailability, for which we offer an impressive portfolio of advanced delivery methods. Metrics manufactured products are now approved by medicines regulators in more than 40 countries. Located in Greenville, NC, Metrics is a proud member of Mayne Pharma. For more information, visit metricscontractservices.com.
Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on the application of drug delivery expertise to commercialize branded and generic pharmaceuticals. Mayne Pharma also provides contract development and manufacturing services to more than 100 clients worldwide. Mayne Pharma has a 40-year track record of innovation and success in developing new oral drug delivery systems, and these technologies have been successfully commercialized in numerous products that continue to be marketed around the world. Mayne Pharma has two drug development and manufacturing facilities based in in Salisbury, Australia and Greenville, USA with expertise in the formulation of complex oral and topical dose forms including potent compounds, modified-release products and poorly soluble compounds. For more information, visit www.maynepharma.com.
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