Estados Unidos da América

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1 EMPRESA INSPECIONADA ENDEREÇO PAÍS LINHA DE PRODUÇÃO Ferring GmbH Wittland 11 and 6, D Kiel E LÍQUIDOS Grünenthal GmbH. Zieglerstraße 6, D Aachen Fournier Laboratories Ireland Demo SA Pharmaceutical Industry Avid Bioservices, Inc. Ebewe Pharma Ges.m.b.H Nfg.KG Ranbaxy Laboratories Emcure Pharmaceuticals Janssen-Cilag S.A de C.V. Sun Pharmaceutical Industries Ltd. Teva Pharmaceuticals USA, inc. Anngrove, Carrigtwohill, Co. Cork 21st km National Road Athens - lamia, Krioneri Attiki, Franklin Avenue, Suite 100, Tustin CA Mondseestrasse, 11 - A-4866, Unterach am attersee Village Batamandi, Paonta Sahib, Distt. Simour, Himachal Pradesh, Plot No. P-1, 2, I.T.B.T. Park, Phase- II, M.I.D.C. Hinjwadi, Pune , Maharashtra. Carretera Federal México-Puebla Km 81,5 San Mateo Capultitlan, CP 74160, Huejotzingo, Puebla Survey No. 259/15, Village Dadra, U.T. Of Dadra & Nagar Haveli, S. 35th Av., Phoenix, Arizona LÍQUIDOS, E Início Irlanda Grécia Áustria México EXTRAZONA E E LÍQUIDOS 3 de 3 de Fim 7 de 12 de quartafeira

2 NovartisPharmaceutical Corporation Excelvision AG Ranbaxy Laboratories Fresenius Kabi Manufacturing SA (PTY) 25 Old Mill Road, Suffern, New York Riethofstrasse 1, CH Hettlingen Industrial Area 3, Dewas, , Madhya Pradesh 6 Gibaud Road, Korsten, Port Elizabeth Cipla Ltd Plot No. 9 & 10 Phase II, Indore Special Economic Zone - Pithampur, Dist, Dhar (M.P) Similasan S/A Chriesiweg 6, 8916, Jonen Pablo Cassará SRL Carhué Matadero - Buenos Aires - CP140-8 Catalent Pharma Solutions L.L.C. Immunex Rhode Island Corporation Indoco Remedies S.C. Sindan-Pharma S.R.L. Delpharm Tours 2725 Scherer Drive North - St. Petersburg - Florida Technology Way, West Greenwich, Rhode Island, L-32, 33 & 34, Verna Industrial Area, Verna, Goa , Ion Mihalache Blvd., Bucharest 1 Rue Paul Langevin, Chambray Les Tours Suíça África do Sul E LÍQUIDOS Suíça Argentina Romênia, LÍQUIDOS, SEMIS E E

3 Bolder Arznelmittel GmbH & Co.KG Rheinische Allee 11, Köln, North Rhine-Westphalia Vifor S.A. Route de Moncor 10, 1752 Villars-sur- Glâne Hospira Australia Pty Ltd. Eurand,Inc. (Aptalis Pharmatech) AbbVie Ireland NL B.V. 1 Lexia Place, Mulgrave, Victoria center Drive Vandalia, ohio Manorhamilton Road, Sligo Micro Labs Plot nº , Phase IV KIADB Industrial Area, Bommasnadra, Bangalore Balkanpharma-Dupnitsa AD Genentech, Inc. 3 Samokovsko Shosse Street, Dupnista, NW Brookwood Parkway Hillsboro, Oregon Unimed Technologies Ltd. Survey n 22 & 24, Village - Ujeti, Post - Baska - Tal - Halol, Ujeti Dist Panchmahal Mipharm S.P.A. Via Bernardo Quaranta, Milão Savior Lifetec Corporation 4F, n 12&16, Chuangye Rd., Xinshi Dist, Tainan Novartis Consumer Health Inc Highway 6, Lincoln 68517, Nebrasca Suíça segunda- Austrália feira Irlanda Bulgária 7 de abril 7 de abril Itália 7 de abril Taiwan abril abril 18 de abril Hetero Labs (Unit VI) APIIC Formulation SEZ, S. N 410&411, Jadcherla (Mandal), Mahaboob Nagar abril

4 Brecon Pharmaceuticals FDC Vitamins, LLC Wye Valley Business Park, Brecon Road, Hay-on-Wye, Hereford, Herefordshire, HR3 5PG NW 60th Avenue Miami Lakes, FL Reino Unido abril 5 de maio Altea Farmacéutica S.A. Carrera 65, 10-95, Bogotá USV Intas Pharmaceuticals Vetter Pharma Fertigung (3 plantas) Sanofi Winthrop Industrie Qilu Pharmaceutical Co., Ltd. Advanced Enzyme Technologies Ltd Wyeth Lederle S.p.A. Natco Pharma Xiamen Amoytop Biotech CO., Ltd. H-17/H-18. O.I.D.C., Mahatma Gandhi Udyog Nagar, Dabhel, Daman Plot 457,458, Matoda, Sanand, Ahmedabad , Gujarat State Plantas de Ravensburg (Schutzenstrasse e Mooswiesen) e Langernagen 180 Rue Jean Jaurès Maisons Alfort NO. 243 Gongyebei Road, Jinan City A-61/62, Malegaon MIDC.Tal. Sinnar, Dist. Nashik Via Franco Gorgone, 6, Zona Industriale 95100, Catania Kothur, Mahaboobnagar District, Andhra Pradesh NO.330, Wengjiao Road, Haicang, Xinyang Industrial Zone, Xiamen, Fujian Colômbia 5 de maio 5 de maio China Itália SEMIS E 5 de maio de maio 26 de maio China 9 de 16 de maio 30 de maio 30 de maio

5 Genzyme Polyclonals S.A.S 23 Boulevard Chambaud de la Bruyère, Lyon 9 de Pharmaxis Ltd Sanofi Chimie Sanofi Winthrop Industrie Onco Therapies Novartis Pharma Produktion GmbH 20 Rodborough Road - Frenchs Forest NSW 2086 Rue Gilles Roberval, 56800, Ploermel 1, rue de la Vierge, Ambares et Lagrave. Plot No.284-B, Bommasandra-Jigni link road, industrial Area,Anekal Taluk, Bengalore Karnataka Öflinger Strasse 44 D-79664, Wehr/Baden Austrália 16 de 16 de 30 de E SEMIS E 7 de julho julho 4 de julho 11 de julho 18 de julho Pfizer Venezuela, S.A. Avenida Henry Ford, Zona Industrial Sur, Parcela 3-2 Venezuela julho 18 de julho Pfizer Ireland Pharmaceuticals Eisai Manufacturing Arena Pharmaceuticals GmbH Little Connell, Newbridge, Co. Kildare. European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL 10 9SN Untere Brühlstrasse 4, 4800 Zofingen Irlanda julho Reino Unido julho Suíça julho GlaxoSmithKline Sharp Corporation 893 River Road, Conshohocken, PA Carland Rd., Conshohocken, Pennsylvania (PA) de 11 de 8 de quartafeira