Lehigh Valley Technologies, Inc. Announces Results of FDA Inspection
ALLENTOWN, Pa., Jan. 9, 2012 /PRNewswire/ — Lehigh Valley Technologies, Inc. (LVT) is pleased to announce the results of a recently completed inspection by the U.S. Food and Drug Administration (FDA). On December 8, 2011, FDA completed an onsite inspection with no Form 483 observations and no discussion points, indicating that there were no negative observations relating to cGMP (current Good Manufacturing Practices). Additionally, FDA has accepted the actions that LVT enacted in response to the Warning Letter issued earlier in the year. Company officials highlight the outcome, which demonstrates LVT’s commitment to manufacturing quality products.
LVT is a specialty pharmaceutical manufacturer engaged in the development and manufacturing of generic and branded pharmaceutical products. LVT is the only company in the United States approved by FDA to manufacture and distribute Oxycodone Hydrochloride (single-ingredient, immediate-release) in oral solution and capsule dosage forms. LVT received approval from FDA in October 2010 for its New Drug Applications (NDAs) for these two products, which are currently distributed by Glenmark Generics Inc., USA.
During 2011, LVT and Glenmark actively supplied and met the market demand for Oxycodone HCl 100 mg/5 mL (20 mg/mL) oral solution and Oxycodone HCl 5 mg capsules. There are no drug shortages for these products. LVT has reaffirmed its continued commitment and ample capacity to manufacture and supply 100% of the consumer demand for these two drug products in 2012.
For more information about LVT or its products, please contact:
Chief Executive Officer
Chief Financial Officer
Main Phone: 610-782-9780
SOURCE Lehigh Valley Technologies, Inc.