May 16, 2008 | Vol. 2 No. 20
Genzyme is expecting sales of Myozyme to fall $45 million below expectations this year because the FDA is requiring the firm to submit a new biologics license application (BLA) to manufacture the product on a larger scale.
Watson Pharmaceuticals expects to launch generic versions of Toprol-XL and Prilosec this year now that the FDA has lifted a warning letter for the firm’s manufacturing facility in Davie, Fla., that had blocked approval of the drugs.
As the Center for Drug Evaluation and Research (CDER) anticipates increasing the number of manufacturing inspections, the FDA’s Office of Regulatory Affairs (ORA) plans to add capacity and staff to its laboratory operations, according to an internal agency memorandum.
Immucor Inc. replied to a warning letter from the Food and Drug Administration that pointed out problems of manufacturing practices in the company.
SunTech Medical has opened a manufacturing facility in Shenzhen, China, the Morrisville-based company said.
PTS, Inc.'s management reported that they have been developing an LOI (Letter of Intent) with a state-owned Chinese medical facilities manufacturer that, if consummated, would involve joint licensing pacts for import and export, plus provide exchanges of technology and other opportunities….
Mindray Medical International Limited, a … developer, manufacturer and marketer of medical devices worldwide, announced the completion of its acquisition of Datascope Corporation's patient monitoring device business pursuant to the terms of the definitive agreement entered into on March 11, 2008.
Cambridge Major Laboratories said Wednesday that it plans to build a new state-of-the-art pharmaceutical ingredient plant next to its headquarters in Germantown.
Bovie Medical Corp., a manufacturer of electrosurgical products, said Wednesday profits plunged in the first quarter, and sales were down slightly, compared to the same period last year.
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