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Schering-Plough To Spend $20 Million To Renovate Facilities
Hopes to add Temodar and Sarasar to product list after FDA approval in 2005
By MARIALBA MARTINEZ
October 16, 2003
Schering-Plough Corp. in Las Piedras will renovate existing manufacturing areas at a cost of approximately $20 million to accommodate two new production lines, said a source in the pharmaceutical industry.
"The company is ready to begin construction for production of Temodar and Sarasar," the source told CARIBBEAN BUSINESS. "If all goes well, final submission to the U.S. Food & Drug Administration should be made by first-quarter 2005."
Temodar is used as a chemotherapy agent in the treatment of tumors. Sarasar belongs to a new class of compounds for the treatment of cancer that inhibit a key enzyme, regulating the growth and proliferation of cancer cells.
Recently, Schering-Plough announced that the U.S. Attorneys Office in New Jersey had closed an investigation on selected products of its manufacturing plants in Las Piedras and Manati. This revelation came a few weeks after the company and former chairman & CEO Richard Kogan agreed to pay penalties of $1 million and $50,000, respectively, to the U.S. government based on violations filed by the U.S. Securities & Exchange Commission (SEC).
This is the largest SEC penalty for a violation of Regulation Fair Disclosure. Kogans penalty is the first demanded by the SEC from an individual in selective-disclosure cases. In 2002, Schering-Plough paid a $500,000 fine to the U.S. Food & Drug Administration as part of a consent degree for violations incurred by the manufacturing company.
Schering-Plough has been established in Las Piedras since 1986, when it took over Miami-based Key Pharmaceuticals and its products. Among them is Theo-Dur, an oral bronchodilator used to treat asthma, chronic bronchitis, and emphysema, which is still produced by the company.
A leader in the development of allergy and respiratory pharmaceutical products, Schering-Plough has invested more than $400 million in its plant over the past five years, adding 300 to its work force of 700. The 318,000-square-foot manufacturing plant is close to completing a 30,000-square-foot expansion that will house new administrative offices, a records center, a cafeteria, an infirmary, and an additional 115 parking spaces all protected by a new security system. Construction should be finished by December.
This Caribbean Business article appears courtesy of Casiano Communications.