PHARMACEUTICS INTERNATIONAL, INC

On September 29, 2011, Region III filed a CAFO simultaneously initiating and resolving civil penalty action against Pharmaceutics International, Inc. (“PII”). The case involves Clean Air Act (“CAA”) claims against PII. The basis of the CAFO is PII’s failure to comply with the CAA, and provisions of the underlying Maryland State Implementation Plan (“SIP”) at PII’s pharmaceutical coating operations located at two (2) separate closely situated locations at 10819 Gilroy Road Hunt Valley, Maryland 21031 (the “Gilroy Road Facility”), and 103 Beaver Court, Cockeysville, Maryland 21030 (the “Beaver Court Facility”) (collectively the “Facilities”). The specific provisions alleged to have been violated include PII’s violation of the emissions limitations which limit volatile organic compound (“VOC”) emissions from facility operations and violations of operating permit requirements. The permit provisions in question are part of a series of permits issued by the State of Maryland pursuant to its state operating permits program which has been approved by EPA as a federally enforceable component of the Maryland SIP.