2Q2009 TYPE5ACTIVETEXT DMF # SUBMIT DATE HOLDER SUBJECT 916 9/24/1965 CIBA CORPORATION TRICLOSAN TOXICOLOGY INFORMATION 989 8/25/1966 HOSPIRA STERILE MANUFACTURING FACILITY IN CLAYTON NC 1639 1/5/1971 ISOTRON PLC "GAMMA RADIATION STERILIZATION PROCESSES AND FACILITIES AS LOCATED IN SWINDON, ENGLAND" 2269 4/26/1974 STERIS-ISOMEDIX SERVICES "CONTRACT STERILIZATION FACILITY IN MORTON GROVE,IL" 2297 6/14/1974 INTERNATIONAL SPECIALTY PRODUCTS POLYVINYLPOLYPYRROLIDONE (CROSPOVIDONE) 2315 7/26/1974 BEN VENUE LABORATORIES INC "STERILE PROCESSING FACILITY IN BEDFORD, OHIO" 2525 8/22/1975 KALI QUALIF OF PROFESSIONAL STAFF--(DMF FORMERLY HELD BY MID-WEST MEDICAL) 2636 3/25/1976 BELL-MORE LABS INC FILLING & FREEZE DRYING METHODS FOR IN-VIVO MATERIAL 2700 6/25/1976 B BRAUN MEDICAL INC STERILIZATION OF LARGE VOL. PARENTERAL SOL 2803 12/10/1976 NATL INST HLTH NCI PRECLINICAL EVALUATIONS 3195 4/21/1978 AQUALON INC TOXICOLOGICAL STUDIES OF NAROSOL HYDROXYETHYL CELLULOSE 3479 3/9/1979 JRS PHARMA LP EXPLOTAB FEEDING STUDY-UNIV OF R.I.(SOD. STARCH GLYCOLATE USP/NF) 3794 4/8/1980 UNIV OF IOWA PHARMACEUTICAL SERVICES COLLEGE OF PHARMACY "STERILE PRODUCTS MANUFACTURING PROCEDURES IN IOWA CITY, IOWA" 4030 11/21/1980 HOLLISTER STIER LABORATORIES LLC SVP FACILITIES 4700 11/4/1982 LILLY RES LABS DIV ELI LILLY CO PROCEDURES FOR STERILE OPERATIONS IN INDIANAPOLIS AND GREENFIELD INDIANA 4858 3/11/1983 SANOFI-ADVENTIS DEUTSCHLAND INC PRECLINICAL STUDIES USING HUMAN INSULIN SEMISYNTHETIC (HOE 21 PH INJ) 5167 12/1/1983 GIVAUDAN SA TOXICOLOGY OF PARSOL 1789 PARTS A & B AS STUDIED BY GIVAUDAN S.A. 5414 6/18/1984 SERONO INC BIOEQUIVALANCE STUDY ON THREE CLOMIPHENE CITRATE PRODUCTS 5767 3/27/1985 STERIS-ISOMEDIX SERVICES "CONTRACT STERILIZATION FACILITY IN SANDY, UTAH." 5821 4/29/1985 STERIS ISOMEDIX SERVICES "CONTRACT STERILIZATION FACILITY IN WHIPPANY, NJ" 5829 5/15/1985 STERIS-ISOMEDIX SERVICES "CONTRACT STERILIZATION FACILITY IN NORTHBOROUGH, MA." 5979 8/16/1985 AVENTIS PHARMACEUTICALS INC. STERILE PROCESSING FACILITY IN ANAGNI (FROSINONE) ITALY 5985 9/6/1985 OSO BIOPHARMACEUTICALS MANUFACTURING LLC STERILE PROCESSING FACILITY IN NEW MEXICO 6293 4/24/1986 MULTIDISCIPLINARY ASSN FOR PSYCHEDELIC STUDIES "MDMA (3,4-METHYLENEDIOXYMETHAMPHETAMINE) IN RATS AND DOGS" 6426 6/12/1986 STERIGENICS INTERNATIONAL "STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN WESTERVILLE, OHIO" 6501 6/18/1986 STERIS-ISOMEDIX SERVICES "CONTRACT STERILIZATION FACILITY IN LIBERTYVILLE (NORTH), ILLINOIS." 6554 8/18/1986 ISOTRON PLC "PLANT DESCRIPTION AND CONTROL PROC. A READING, ENGLAND" 6555 8/18/1986 ISOTRON PLC "MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BRADFORD, ENGLAND." 6672 8/27/1986 STERIGENICS INTERNATIONAL "STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN FORT WORTH, TEXAS" 6894 3/16/1987 PROCESS TECHNOLOGY INC "STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN HAW RIVER, NC" 6913 3/16/1987 STERIGEMICS INTERNATIONAL "STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN SALEM, NEW JERSEY" 7105 7/27/1987 PHARMACIA AND UPJOHN INC "STERILE AND NON-STERILE MFG FACILITIES IN PUURS, BELGIUM" 7159 9/29/1987 NATL INST HLTH NIAID AIDS DIV CURRICULUM VITAES 7184 10/12/1987 GIVAUDAN CORPORATION CLINICAL STUDIES REGARDING THE USE OF PARSOL MCX 8341 12/14/1989 IONISOS FACILITY AND PROCEDURES FOR GAMMA RAY STERILIZATION IN DAGNEUX FRANCE 8477 3/20/1990 DAIDS CURRICULUM VITAE OF THE PEDIATRIC INVESTIGATORS FOR AIDS (CTG) 8570 5/14/1990 ISOTRON NEDERLAND BV "GAMMA IRRADIATION FACILITY LOCATED IN EDE, THE NETHERLANDS" 8781 10/19/1990 NATL INST HLTH NHI REFERENCE INFORMATION (CURRICULA VITAE) 8786 10/16/1990 PHARMACHEMIE BV "STERILE MANUFACTURING FACILITY IN HAARLEM,NETHERLANDS" 8836 11/16/1990 STERIS-ISOMEDIX SERVICES "CONTRACT STERILIZATION FACILITY IN SPARTANBURG, SOUTH CAROLINA." 9227 6/10/1991 NATL INST HLTH NIAID ANTIVIRAL STUDY GROUP INFORMATION TO SUPPORT CLINICAL STUDIES 9255 7/22/1991 DRAXIS PHARMA INC "MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KIRKLAND, QUEBEC, CANADA." 9428 12/2/1991 JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENTLLC NON-CLINICAL PHARMACOLOGY TOXICOLOGY STUDIES ON HYDROXYPROPYL-BETA-CYCLODEXTRIN (ENCAPSIN HPB) 9642 3/27/1992 PIERRE FABRE MEDICAMENT PRODUCTION/AQUITAINE PHARM INTERNATIONAL "STERILE MANUFACTURING FACILITY IN PAU IDRON, FRANCE" 9859 9/3/1992 INTERNATIONAL PHARMACEUTICAL AEROSOL CONSORTIUM FOR TOXICOLOGICAL TESTING TOXICOLOGY AND PHARMACOKINETICS DATA ON THE HYDROFLUOROALKANE HFA-134A. 10076 12/18/1986 ACS DOBFAR SPA "STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AT THE VIALE ADDETTA PLANT IN MILANO, ITALY" 10077 8/27/1991 ACS DOBFAR SPA "STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AT THE VIALE ROSSINI PLANT IN MILANO, ITALY" 10096 2/9/1993 NATIONAL INSTITUTES OF HEALTH ANTI-FUNGAL DRUGS 10243 4/30/1993 IONISOS "FACILITY AND PROCEDURES FOR GAMMA RAY STERILIZATION IN SABLE SUR SARTHE, FRANCE" 10255 5/18/1993 ISOTRON WESTPORT LIMITED "COBALT 60 GAMMA IRRADIATION CONTRACT STERILIZATION FACILITY LOCATED IN WESTPORT, CO. MAYO, IRELAND" 10304 6/24/1993 BAXTER HEALTHCARE CORP "STERILE PROCESSING FACILITY IN BLOOMINGTON, INDIANA." 10378 7/29/1993 INTERNATIONAL PHARMACEUTICAL AEROSOL CONSORTIUM FOR TOXICOLOGICAL TESTING I "SAFETY DATA ON HFA-227 (1,1,1,2,3,3,3 HEPTAFLUOROPROPANE)." 10581 11/19/1993 NERVIANO MEDICAL SCIENCE SRL "STERILE AND NON-STERILE FACILITIES LOCATED IN MILAN, ITALY" 10729 2/23/1994 GLAXO WELLCOME INC PHARMACOLOGY AND TOXICOLOGY INFORMATION REGARDING PROPELLANT HFA-134A (GR106642X) 10733 2/15/1994 GAMMASTER PROVENCE SA "STERILE PROCESSING FACILITY LOCATED IN MARSEILES, FRANCE" 10930 6/1/1994 STERIGENICS INTERNATIONAL "STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN CHARLOTTE, NC." 10931 6/1/1994 STERIGENICS INTERNATIONAL "STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN CORONA, CA" 11040 8/15/1994 ISOTRON PLC "STERILE PROCESSING PROCEDURES AS LOCATED IN DAVENTRY, ENGLAND" 11056 9/2/1994 MEDIMMUNE ONCOLOGY INC STERILE PROCESSING FACILITY LOCATED IN NIJMEGEN THE NETHERLANDS 11240 12/7/1994 "AMERICAN PHARMACEUTICAL PARTNERS, INC." "LIQUID DRUGS IN VIALS ASEPTIC FILL PROGRAM IN GRAND ISLAND,NY." 11307 12/7/1994 "AMERICAN PHARMACEUTICAL PARTNERS, INC." "TERMINAL STERILIZATION PROGRAM IN GRAND ISLAND, NEW YORK." 11342 2/13/1995 "AMERICAN PHARMACEUTICAL PARTNERS, INC." "LIQUID AND LYOPHILIZED DRUGS IN VIALS ASEPTIC FILL PROGRAM IN MELROSE PARK, IL" 11403 3/27/1995 "AMERICAN PHARMACEUTICAL PARTNERS, INC." "TERMINAL STERILZATION PROGRAM IN MELROSE PARK, ILLINOIS." 11648 9/6/1995 WEST PHARMACEUTICAL SERVICES INC "WESTAR MANUFACTURED IN JERSEY SHORE, PA, SINGAPORE, ESCHWEILER, FEDERAL REPUBLIC OF GERMANY, AND LE NOUVION-EN-THIERACHE, FRANCE." 11713 10/20/1995 "AMERICAN PHARMACEUTICAL PARTNERS, INC." "POWDER DRUGS IN VIALS STERILIZATION PROCESS VALIDATION DOCUMENTATION (ASEPTIC FILL) IN GRAND ISLAND, NEW YORK." 12343 1/2/1997 STELMI SA "ULTRACLEAN-6 WASHING PROCESS, MANUFACTURED IN GRANVILLE, FRANCE" 12377 2/24/1997 NIAID DAIDS POLICIES AND PROCEDURES PERTAINING TO CLINICAL TRIALS CONDUCTED UNDER DAIDS-SPONSORED INDS 12410 2/28/1997 CIBA VISION STERILE MANUFACTURING STERILE MFG IN FACILITIES FOR THE PRODUCTION OF OPHTHALMIC AND CONTACT LENS SOLUTIONS 12422 3/7/1997 STERIGENICS INTERNATIONAL "STERILIZATION FACILITY IN GURNEE, IL" 12486 4/24/1997 STERIGENICS INTERNATIONAL "CONTRACT STERILIZATION FACILITY IN HAYWARD, CA" 12682 6/16/1997 BRISTOL MYERS SQUIBB CO "FACILITIES FOR PARENTERAL MANUFACTURING (BUILDING D) LOCATED IN MAYAGUEZ, PR." 12783 12/12/1997 MALLINCKRODT INC "DESCRIBING THE QUALIFICATIONS OF AN EXPANDED ASEPTIC PROCESSING AREA IN MARYLAND HEIGHTS, MISSOURI." 12872 1/28/1998 VIRCO BVBA "ANTIVIROGRAM (DOCUMENT IDENTIFICATION: VIRCO/FDA/98001) IN MECHELEN, BELGIUM." 13044 6/24/1998 CATALYTICA PHARMACEUTICALS INC STERILE PRODUCT OPERATION-SOUTH(SPO-SOUTH) IN GREENVILLE NORTH CAROLINA 13134 8/17/1998 FRESENIUS KABI NORGE A/S "STERILE MANUFACTURING OPERATIONS IN HALDON, NORWAY" 13196 9/21/1998 STERIS-ISOMEDIX SERVICES CONTRACT STERILIZATION FACILITY IN GROVEPORT OHIO 13238 9/28/1998 STERIS-ISOMEDIX SERVICES CONTRACT STERILIZATION FACILITY IN CHESTER NY 13256 10/1/1998 STERIS-ISOMEDIX SERVICES "CONTRACT STERILIZATION FACILITY IN VEGA ALTA, PUERTO RICO" 14141 5/17/1999 CATALYTICA PHARMACEUTICALS INC STERILE PRODUCT OPERATION-NORTH (SPO-NORTH) IN GREENVILLE NORTH CAROLINA 14360 8/9/1999 VIRCO BVBA GENOTYPIC RESISTANCE TESTING FOR HIV AS DEVELOPED IN MECHELEN BELGIUM 14364 8/9/1999 CYDEX PHARMACEUTICALS INC SULFOBUTYLETHER BETACYCLODEXTRIN(CAPTISOL) SAFETY STUDIES 14368 8/30/1999 CHESAPEAKE BIOLOGICAL LABORATORIES INC MANUFACTURING SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL FOR NEW STERILE PROCESSING FACILITY IN BALTIMORE MD 14408 8/31/1999 GULF PHARMACEUTICAL INUSTRIES "STERILE MANUFACTURING FACILITIES LOCATED IN RAS-AL-KAIMAH, UNITED ARAB EMIRATES" 14621 11/26/1999 CHEMUNEX DESCRIPTION AND DATA TO SUPPORT USE OF SOLID PHASE CYTOMETER FOR THE MEASUREMENT OF VIABLE MICRO-ORGANISMS IN PHARMACEUTICAL WATER SYSTEMS 14782 3/16/2000 PFIZER INC BUILDING 41 ASEPTIC FACILITY UPGRADE 14798 3/28/2000 MALLINCKRODT INC MALLINCKRODT INC-MARYLAND HEIGHTS PARAMETRIC RELEASE PROGRAM IN MARYLAND HEIGHTS MISSOURI 14843 3/10/2000 MEDIS LABORATORIES MEDICAMENTS STERLIES - S.A. "STERILE PROCESSING FACILITY LOCATED IN NABEUL, TUNISIA" 15053 9/12/2000 SOUTHWEST ONCOLOGY GROUP "CLINICAL INVESTIGATION METHODS TO ASSURE PATIENT SAFETY AND SCIENTIFIC INTEGRITY AS PERFORMED AT SAN ANTONIO, TEXAS" 15124 10/24/2000 PFIZER INC "STERILE PRODUCTS MANUFACTURING FACILITIES IN NERVIANO, ITALY" 15343 12/14/2000 WEST PHARMACEUTICAL SERVICES INC "CONTRACT TESTING FOR PACKAGING COMPONENTS FOR THE PHARMACEUTICAL INDUSTRY IN LIONVILLE, PA." 15554 7/26/2001 ADVANCED MICRODEVICES PVT LTD MEMBRANE DISC AND CARTRIDGE FILTERS USED FOR STERILIZATION OF DRUG PRODUCTS 15653 10/5/2001 CENTERS FOR DISEASE CONTROL AND PREVENTION "PROVISIONAL DATA REPORT ON MALARIA SURVEILLANCE AND USE OF ANTIMALARIAL CHEMOPROPHYLAXIS AS MANUFACTURED IN ATLANTA, GA" 15775 12/17/2001 INTERNATIONAL SPECIALITY PRODUCTS "TOXICOLOGY STUDIES ON PHARMASOLVE (N-METHYL-2-PYRROLIDONE) AS MANUFACTURED IN WAYNE, NJ" 15911 3/22/2002 SANDOZ GMBH "BIOTECH PRODUCTION BUILDING 211 AS MANUFACTURED IN KUNDL, AUSTRIA" 16096 8/5/2002 PATHEON UK LTD SWINDON OPERATIONS "STERILE MANUFACTURING AT SWINDON, UNITED KINGDOM." 16177 9/26/2002 134A CONSORTIUM "ACCEPTANCE TESTING OF HFA-134A(1,1,1,2-TETRAFLUOROETHANE) AS MANUFACTURED BY INEOS FLUOR." 16269 11/26/2002 NATIONAL INSTITUTES HEALTH NATIONAL INSTITUTE ALLERGY AND INFECTIOUS DISEASES CURRICULA VITAE (CV) FOR HIV PREVENTION TRIALS NETWORK (HPTN) INVESTIGATORS. 16307 12/12/2002 LILLY FRANCE SA "PROCEDURES FOR STERILE OPERATIONS IN BUILDING 200, FEGERSHEIM, FRANCE." 16319 12/9/2002 PHARMACIA PERTH PTY LTD "PERTH ASEPTIC ONCOLOGY MANUFACTURING FACILITY IN WESTERN AUSTRALIA, AUSTRALIA." 16643 6/12/2003 SANTEN OY "STERILIZATION PROCESS FOR CONTINUOUS MOTION (CM1) COMPOUNDING AND FILLING LINE AS MANUFACTURED IN TAMPERE, FINLAND." 16702 6/26/2003 MERCK RESEARCH LABORATORIES L-829165 POSITRON EMISSION TOMOGRAPHY (PET) TRACER SAFETY AND PHARMACOLOGY REFERENCE DATA 16770 12/4/2003 BOEHRINGER INGELHEIM RCV GMBH & CO KG "CONTRACT MANUFACTURING FACILITY IN VIENNA, AUSTRIA." 16885 10/6/2003 BASF AKTIENGESELLSCHAFT "KOLLICOAT (R) IR TOXICOLOGY STUDIES IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY" 16892 9/3/2003 ALTHEA TECHNOLOGIES INC "ASEPTIC FORMULATION, FILL, AND FINISH FACILITY IN SAN DIEGO, CA." 16941 10/31/2003 LAUREATE PHARMA INC "CONTRACT MANUFACTURING FACILITY IN PRINCETON, NJ." 17017 12/11/2003 WEST PHARMACEUTICAL SERVICES INC "WESTAR(R) RS PROCESS AS MANUFACTURED IN LE NOUVION EN THIERACHE, FRANCE." 17159 2/4/2004 DISCOVERY LABORATORIES INC "STERILE MANUFACTURING FACILITY IN TOTOWA, NJ." 17200 2/18/2004 WAISMAN CENTER "WAISMAN CLINICAL BIOMANUFACTURING FACILITY IN MADISON, WI." 17323 8/6/2004 AMGEN INC "ABGENIX PRODUCTION FACILITIES IN FREMONT, CA." 18047 1/18/2005 MONOGRAM BIOSCIENCES INC "PHENOSENSE(TM) HIV ENTRY TROPISM ASSAY VALIDATION PACKET AS MANUFACTURED IN SOUTH SAN FRANCISCO, CA." 18328 1/31/2005 DSM BIOLOGICS CO B V "MAMMALIAN MANUFACTURING AREAS IN AP GRONINGEN, THE NETHERLANDS." 18369 4/4/2005 A-BIO PHARMA PTE LTD CGMP MANUFACTURING FACILITY FOR PRODUCTION OF BIOLOGICS FOR CLINICAL TRIALS IN SINGAPORE. 18370 5/11/2005 WEST PHARMACEUTICAL SERVICES INC "WESTAR(R) RS PROCESS IN ESCHWEILER, FEDERAL REPUBLIC OF GERMANY." 18438 5/18/2005 PFIZER INC "HYDROXYPROPYL METHYLCELLULOSE ACETATE SUCCINATE (HPMCAS) AS MANUFACTURED IN NEW LONDON, CT." 18455 6/16/2005 WEST PHARMACEUTICAL SERVICES INC "WESTAR(R) RS PROCESS IN JURONG, SINGAPORE." 18456 4/15/2005 DIVISION OF AIDS NIAID CURRICULA VITAE (CV) FOR ACUTE INFECTION AND EARLY DISEASE RESEARCH PROGRAM (AIEDRP) INVESTIGATORS. 18882 10/3/2005 ABBOTT VASCULAR INC CLINICAL AND NON-CLINICAL STUDIESFOR ABT-578 (ZOTAROLIMUS) 19164 12/23/2005 DEVELOPMENT CENTER BIOTECHNOLOGY "CGMP MANUFACTURING FACILITY FOR PRODUCTION OF BIOPHARMACEUTICALS FOR CLINICAL TRIALS, TAIWAN R.O.C." 19206 2/16/2006 CATALENT PHARMA SOLUTIONS LLC "CARDINAL HEALTH'S STERILE MANUFACTURING FACILITIES IN SAN DIEGO, CA." 19230 3/13/2005 STERIS CORP "STERIS INC ISOMEDIX SERVICES FACILITY IN NOGALES, AZ." 19235 9/23/2005 CARIDIAN BCT N.IRELAND LTD "GAMBRO MANUFACTURING FACILITY IN ANTRIM, NORTHERN IRELAND." 19371 4/17/2006 PAIN THERAPEUTICS INC "REFERENCE INFORMATION TO SUPPORT THE SAFETY OF TRIACETIN (GLYCEROL TRIACETATE) USP, AS A PHARMACEUTICAL EXCIPIENT." 19380 4/18/2006 PAIN THERAPEUTICS INC REFERENCE INFORMATION TO SUPPORT THE SAFETY OF CELLULOSE ACETATE BUTYRATE 381-20BP AS A PHARMACEUTICAL EXCIPIENT. 19381 4/19/2006 PAIN THERAPEUTICS INC REFERENCE INFORMATION TO SUPPORT THE SAFETY OF ISOPROPYL MYRISTATE AS A PHARMACEUTICAL EXCIPIENT. 19382 4/20/2006 PAIN THERAPEUTICS INC REFERENCE INFORMATION TO SUPPORT THE SAFETY OF ETHYL LACTATE AS A PHARMACEUTICAL EXCIPIENT. 19418 5/5/2006 DAIKYO SEIKO LTD "RSV COMPONENT WASHING PROCESS AT TOCHIGI, JAPAN." 19494 5/4/2006 ISOTRON NEDERLAND BV "ISOTRON NEDERLAND FACILITY IN EDE, THE NETHERLANDS." 19654 7/28/2006 CELSIS INC "CELSIS RAPISCREEN HEALTH AS MANUFACTURED IN LANDGRAAF, THE NETHERLANDS." 19754 8/15/2006 SANDOZ GMBH STERILIZATION PROCESS VALIDATION INFORMATION FOR THE STERILE PENICILLIN PLANT AS MANUFACTURED IN KUNDL TYROL AUSTRIA 19896 5/25/2005 DIOSYNTH BV DOWN STREAM PROCESSING FACILITY LOCATED IN OSS THE NETHERLANDS 19944 11/7/2006 CELSIS INC CELSIS AKUSCREEN AS MANUFACTURED IN LANDGRAAF THE NETHERLANDS 20078 12/20/2006 BIOPHARMA S R L BIOPHARMA SRL MANUFACTURING IN ROMA ITALY 20131 1/9/2007 COLORCON INC SUPPLEMENTARY INFORMATION FOR COLORCON PRODUCT STARCAP 1500 CO-PROCESSED STARCH EXCIPIENT AS MANUFACTURED IN GREENVILLE IL 20197 1/22/2007 NOVO NORDISK PHARMACEUTICAL INDUSTRIES INC STERILIZATION VALIDATION PACKAGE AS MANUFACTURED IN CLAYTON NC 20324 2/28/2007 NANOINK INC PHARMACEUTICAL BRAND PROTECTION AND ANTI-COUNTERFEITING INSTRUMENTATION AND PROCESS AS MANUFACTURED IN SKOKIE IL 20493 4/30/2007 CATALENT PHARMA SOLUTIONS INC CARDINAL HEALTH NORTH RALEIGH STERILE MANUFACTURING FACILITY 20555 5/22/2007 ASEPTIC TECHNOLOGIES SA PHARMACEUTICAL FILLING FACILITY FOR FILLING STERILE INJECTABLE DEVELOPMENT SAMPLES AND CLINICAL SUPPLIES AT LES ISNES BELGIUM 20757 7/20/2007 PATHEON ITALIA SPA "STERILE AREA 1 DEPARTMENT AT MONZA FACILITY IN MILAN, ITALY." 20817 8/15/2007 QSV BIOLOGICS LTD "EDMONDON FACILITY IN ALBERTA, CANADA" 20828 8/22/2007 DEET JOINT VENTURE DEET TASK FORCE "NON-CLINICAL DATA FOR N,N-DIETHYL-META-TOLUAMIDE AS MFG BY ELGIN FINE CHEMICALS INC IN ELGIN, SC; MT HOLLY CLARIANT CORP IN MT HOLLY, NC; VERTELLUS PERFORMANCE MATERIALS INC IN GREENSBORO, NC; QINGDAO SANLI CHEM ENGINEERING TECH CO. LTD" 20859 9/10/2007 AAIPHARMA INC "STERILE MANUFACTURING FACILITY IN CHARLESTON, SC" 20880 9/18/2007 WEST PHARMACEUTICAL SERVICES INC "WESTAR(R) READY-TO-USE (RU) STERILIZATION PROCESS IN JERSEY SHORE, PA" 21000 11/12/2007 AMGEN INC. "AML ASEPTIC PROCESSING WAREHOUSING AND LABORATORIESIN JUNCOS, PUERTO RICO " 21020 11/8/2007 INJECTALIA SRL "MANUFACTURING FACILITY IN ROME, ITALY" 21218 12/18/2007 LEK PHARMACEUTICALS DD "STERILE MANUFACTURING FACILITY IN LJUBLJANA, SLOVENIA" 21219 12/20/2007 ELI LILLY AND CO "PROCEDURES FOR STERILE OPERATIONS IN BUILDING 103, INDIANAPOLIS, INDIANA" 21359 4/25/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "STERILE PROCESSING DETAILS OF PLANT - 32 WALUJ, INDIA" 21494 5/1/2008 NOVO NORDISK A/S "STERILIZATION VALIDATION PACKAGE IN BAGSVAERD, DENMARK" 21530 4/9/2008 BIOCON LIMITED "MANUFACTURING FACILITY OF BIOCON LIMITED AT BANGALORE, INDIA" 21566 5/21/2008 NATIONAL INSTITUTES HEALTH NATIONAL INSTITUTE ALLERGY INFECTIOUS DISEASES ANTHRAX ANIMAL MODEL 21586 4/23/2008 STELMI SA "STERILE ELASTOMERIC CLOSURE AND ITEMS AS MANUFACTURED IN GRANVILLE CEDEX, FRANCE" 21639 2/4/2008 IONISOS "FACILITY AND PROCEDURES FOR ELECTRON BEAM STERILIZATION IN CHAUMESNIL, FRANCE" 21737 6/26/2008 ACS DOBFAR SPA VIALE ADDETTA PLANT - SMART PAK PLANT 21742 6/27/2008 NOVARTIS PHARMACEUTICALS CORP DRUG SUBSTANCE MANUFACTURING AT NOVARTIS BPO HUNINGUE 21748 6/24/2008 COGNATE BIOSERVICES INC CONTRACT MANUFACTURING FACILITIES 21940 9/2/2008 BIOVIGILANT SYSTEMS INC "IMD-A-200-1 AS MANUFACTURED IN TUCSON, AZ" 21995 9/19/2008 GE HEALTHCARE INC "FASTLAB PET SYNTHESIZER AS MANUFACTURED IN LONCIN, BELGIUM" 21996 9/2/2008 BIOVIGILANT SYSTEMS INC "IMD-A-220-4 AS MANUFACTURED IN TUCSON, AZ" 22171 11/11/2008 PFIZER IRELAND PHARMACEUTICALS PRODUCTION MODULE 2 (PM2) ASEPTIC FACILITY 22182 10/24/2008 ONCO THERAPIES LTD STERILE MANUFACTURING FACILITY FOR ONCOLOGICAL PRODUCTS 22241 11/4/2008 MICROTROL STERILISATION SERVICES PVT LTD GAMMA IRRADIATION STERILISATION TREATMENT FOR MEDICAL DEVICES AS MANUFACTURED IN BENGALOORU INDIA 22287 12/10/2008 ACS DOBFAR SPA VIALE ADDETTA PLANT-CRYSTALLIZATION PLANT 2 22477 1/22/2009 AUROBINDO PHARMA LTD "STERILE MANUFACTURING FACILITY OF AUROBINDO PHARMA LIMITED, UNIT-V AT HYDERABAD, INDIA" 22514 1/30/2009 WEST PHARMACEUTICAL SERVICES INC "WESTAR LINED SEAL RS WASHING PROCESS AS PERFORMED IN ESCHWEILER, GERMANY" 22517 2/6/2009 AXELLIA PHARMACEUTICALS APS "STERILE VALIDATION PACKAGE FOR VANCOMYCIN HCL VIALS IN COPENHAGEN, DENMARK" 22554 2/4/2009 BASF SE TOXICITY REPORTS FOR KOLLICOAT® RS 30 D 22618 3/10/2009 LUITPOLD PHARMACEUTICALS INC "SUPPORTING FACILITY, EQUIPMENT & VALIDATION INFORMATION FOR MANUFACTURING FACILITY IN SHIRLEY, NY" 22743 4/20/2009 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG BIOPHARMACEUTICAL PRODUCTION FACILITY LOCATED IN BIBERACH GERMANY 22753 6/25/2009 SANDOZ CANADA INC STERILE MANUFACTURING FACILITY LOCATED IN BOUCHERVILLE QC CANADA 22759 4/24/2009 HAUPT PHARMA LATINA SRL STERILE PEN POWDERS ASEPTIC FACILITY LOCATED IN LATINA ITALY 22779 5/13/2009 LABORATOIRES THISSEN SA STERILIZATION PROCESS VALIDATION IN APPLICATIONS FOR HUMAN AND VETERINARY DRUG PRODUCTS LOCATED IN BRAINE I ALLEUD BELGIUM 22780 4/30/2009 PHASE V TECHNOLOGIES INC PHASE V® OUTCOMES INFORMATION SYSTEM LOCATED IN WELLESLEY HILLS MA 22831 5/29/2009 AUROBINDO PHARMA LTD STERILE MANUFACTURING FACILITY OF AUROBINDO PHARMA LIMITED UNIT VI LOCATED IN HYDERABAD INDIA 22844 6/8/2009 WEST PHARMACEUTICAL SERVICES INC WESTAR® READY TO USE (RU) GAMMA IRRADIATED ELASTOMERS LOCATED IN ESCHWEILER GERMANY 22896 5/11/2009 INDUSTRIAL TECHNOLOGY RESEARCH INSTITUTE CELL MANUFACTURING FACILITY LOCATED AT CHUTUNG HSINCHU TAIWAN