White Bear Lake, MN - Francesco Autuori, President, Chemi S.p.A., Milan, Italy, proudly announces that Chemi’s manufacturing facility, ITF Chemical Ltda., Camacari, Bahia, Brazil, has been inspected by the Department of Health & Human Services, Public Health Service, of the Food and Drug Administration, and has been granted acceptable status under FDA’s strict inspection guidelines. Previously owned by Smith Kline Beecham and acquired by Chemi in 2000, the facility has been manufacturing active pharmaceutical ingredients (APIs) since 1984, and has been FDA inspected since 1995. In addition, the Brazilian Health Ministry / ANVISA - National Agency of Sanitary Surveillance, has issued a specific authorization for the manufacture of phosphatidylserine (PS) and related products to this current good manufacturing practices (cGMP) compliant facility.
Since its acquisition, Chemi has invested heavily in the modernization and expansion of its Brazilian plant, now fully dedicated to production of APIs and nutraceutical ingredients, including SerinAid® PhosphatidylSerine (PS) and IronAid® Iron Protein Succinylate (IPS). This successful inspection completes the string of FDA audits for Chemi’s production facilities begun in 2004. Chemi’s other facilities located in Cinisello Balsamo (Milan, Italy) and in Patrica (Rome, Italy) were successfully inspected in March 2004.
In November 2004, Chemi announced the beginning of a new expansion phase, including the construction of new R&D and QC facilities, a new plant for API manufacture, and a new warehouse, to be completed in late 2005. The opening of new lines for PS production (standard and identity preserved) and a complete upgrade of drying and milling rooms will be included in the expansion. Under current plans, Chemi’s total PS production capacity is scheduled to double within 2005, with a further 30% increase the following year, allowing Chemi to respond with greater flexibility and efficiency to the growing demand for PS and other nutraceutical ingredients.
The FDA provided an Establishment Inspection Report (EIR) to Chemi at the conclusion of this inspection, as the FDA is working diligently to make the regulatory process and its activities more transparent to this highly regulated industry. Chemi will continue in its efforts to ensure continued compliance with its cGMPs.
Scott Hagerman, president of Chemi Nutra said, “We are extremely pleased that our Brazilian manufacturing facility has satisfactorily passed another round of FDA inspections. Our customers can rest assured that Chemi Nutra and its products are well positioned for the new GMP regulations that are being phased in to the nutritional products industry, and also prepared for the growing demand for PS, an effective, science-proven nutraceutical used for cognitive health and cortisol suppression.”
Chemi Nutra is the US business unit of parent company Chemi S.p.A., a privately held pharmaceutical and nutraceutical company based in Milan, Italy. Chemi, with cGMP certified manufacturing facilities in Italy and Brazil, is best known in the US nutritional arena for its introduction of phosphatidylserine (PS), the popular dietary supplement which has been granted two health claims by the FDA, and is used to enhance learning, memory, and concentration.
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