certificate - fresenius kabi€¦ · management service enclosure of certificate no.: 12 100 24126...

Management Service

CERTIFICATE The Certification Body

of TÜV SÜD Management Service GmbH

certifies that

FRESENIUS KABI

Fresenius Kabi AG Else-Kröner-Str. 1

61352 Bad Hornburg GERMANY

including the sites and scope of application

see enclosure

has established and applies a Quality Management System.

An audit was performed, Report No. 70083720.

Proof has been furnished that the requirements according to

ISO 9001:2008

are fulfilled.

The certificate is valid from 2017-05-19 until 2018-09-14.

Certificate Registration No. 12 100 24126 TMS.

Product Compliance Management Munich, 2017-08-23

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TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www. tu ev-sued .de/ certifi cate-va I id ity-ch eck

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Enclosure of Certificate No.:

12 100 24126 TMS

Sites

Begion Euc_or~e

Fresenius Kabi AG Else-Kröner-Str. 1 61352 Bad Hornburg GERMANY

Fresenius Kabi Austria GmbH (Production Uni! Linz and Marke! Uni! Product Partnering Linz) Estermannstr. 17 4020 Linz AUSTRIA

Fresenius Kabi Austria GmbH Hafnerstr. 36 8055 Graz AUSTRIA

Fresenius HemoGare Austria GmbH Pebering 19 5301 Eugendorf AUSTRIA

Fresenius Kabi N.V. Brandekensweg 9 2627 Schelle BELGIUM

Fresenius Kabi Bulgaria EOOD 1 Alexandar Jendovstr., 6th floor, ap 37 1113 Sofia BULGARIA

Fresenius Kabi (Schweiz) AG Aawasserstrasse 2 6370 Oberdorf NW SWITZERLAND

Sitex SA Ghemin des Aulx 12 1228 Plan les Ouates SWITZERLAND

Fresenius Kabi Horatev GZ s.r.o. Hoi'atev 104 289 13 Hoi'atev GZEGH REPUBLIG

Fresenius Kabi s.r.o. Zeletavska 1525/1 140 00 Praha 4 GZEGH REPUBLIG

Scope of application

Gertificate Holderand Gentral Function

Production, Logistics, Sales and Marketing of Liquid Pharmaceuticals and Active Pharmaceutical lngredients

Development and Produclien of Liquid and Solid Pharmaceuticals, Logistics, Sales and Marketing of Medicinal Products, Enteral Nutrition, Medical Devices and Other Health Gare Products and Technical Service

Produclien of Nonactive Medical Devices, Logistics, and Sales of Medical Devices

Logistics, Sales and Marketing of Medicinal Products, Enteral Nutrition, Medical Devices and Other Health Gare Products and Services and Technical Service

Sales and Marketing of Medicinal Products, Enteral Nutrition, Medical Devices and Services

Logistics, Sales and Marketing of Medicinal Products, Enteral Nutrition and Medical Devices and Services including Technical Service

Produclien of Patient-specific Salutions of Pharmaceuticals, Sales of Medicinal Products, Enteral Nutrition and Medical Devices and Services including Technical Service

Produclien of Nonactive Medical Devices


Product Gompliance Management Munich, 2017-08-23

of 15

((IDAkkS ,., Deutsche

Akkreditierungsstelle D-ZM-14143-01-00

TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www. tuev-su ed. de/ ce rtificate-va I i d ity-check

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12 100 24126 TMS

Sites Scope of application

B.eflio.a Euco.~e

Fresenius Kabi Deutschland GmbH Sales and Marketing of Pharmaceuticals,

Else-Kröner-Str. 1 Products for Enteral Nutrition and Medical Devices,

61352 Bad Hornburg Sales of Patient Specific Salutions of Pharmaceuticals and for Enteral Nutrition. Management of

GERMAN V Patient Transfer in the Nonclinical Area

Fresenius Kabi Deutschland GmbH (Production Unit Enteral Nutrition)

Production and Logistics Daimlerstr. 22 61352 Bad Hornburg

of Enteral Nutrition

GERMANY

Fresenius HemoCare GmbH Development and Production of

Gruener Weg 10 Active Medical Devices and

61169 Friedberg Labaratory Devices

GERMANY

Fresenius Kabi Deutschland GmbH (Production Unit Third Party Manufacturing) Coordination of Third Party Manufacturing Pfingstweide 53 61169 Friedberg GERMANY

Fresenius Kabi Deutschland GmbH (Werk Friedberg) Freseniusstr. 1 61169 Friedberg GERMANY

Fresenius Kabi Deutschland GmbH (Werk Bad Hersfeld) Robert-Koch-Str. 5 36251 Bad Hersfeld GERMANY

Fresenius Kabi Deutschland GmbH (Werk Mihla) Gartenstr. 9 99826 Mihla GERMANY

Fresenius Kabi Deutschland GmbH Zeppelinstr. 1 c 85375 Neufahrn GERMANY

(External Production) and Release of Medicinal Products and Medical Devices

Development and Production of Liquid Pharmaceuticals, Active Pharmaceutical lngredients, Enteral Nutrition and Irrigation Salutions and Services

Development and Production of Nonactive Medical Devices, Logistics, Sales and Marketing of Medical Devices

Production of Nonactive Medical Devices

Manufacturing and Logistic/Distribution of Patient specific Campeunding Products for Parenteral Nutrition Therapy; Logistic/Distribution of Pharmaceuticals and Medical Devices; Manufacturing, Packaging, Labeling and Logistic/Distribution of IMPs and Contract Manufacturing Products


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(~ DAk~~"h• Akkreditierungsstelle D-ZM-14143-01-00

TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www.tuev-sued.de/certificate-valid ity-check

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Management Service


12 100 24126 TMS

Sites

Begion Eucoge

MC Medizintechnik GmbH Am Neuen Berg 8 63755 Alzenau-Hörstein GERMANY

Fresenius Kabi Logistik GmbH Freseniusstr. 1 61169 Friedberg GERMANY

Fresenius Kabi AB lslands Brygge 57 2300 Klllbenhavn S. DENMARK

Fresenius Kabi Espana S.A.U. Marina, 16-18, 08005 Barcelona SPAIN

Fresenius Kabi Espana S.A.U. Dr. Ferran , 12 08339 Vilassar de Dalt SPAIN

Fresenius Kabi AB Valimotie 13 b B 00380 Helsinki FINLAND

Fresenius Kabi France S.A.S. 5, place du Marivel 92316 Sevres Cedex FRANCE

Fresenius Kabi France S.A.S. (Oral and Enteral Nutrition Division) 265, rue de Ia Decouverte, CS 47667 31676 Labege Cedex FRANCE


Service of Medical Devices and Service Training

Logistics of Medicinal Products, Enteral Nutrition and Medical Devices and Services

Logistics, Sales, Marketing and Technical Service

Logistics, Sales and Marketing of Medicinal Products, Enteral Nutrition and Medical Devices

Development, Production and Logistics of Liquid Pharmaceuticals and Irrigation Salutions and Technical Service

Logistics, Sales and Marketing of Medicinal Products, Enteral Nutrition, Medical Devices and Other Health Care Products and Services including Technical Service

Logistics, Sales and Marketing of Medicinal Products and Medical Devices

Logistics, Sales and Marketing of Enteral Nutrition and Medical Devices

(( DAkkS Deutsche Akkreditierungsstelle 0-ZM-14143-01-00 Product Compliance Management

Munich, 2017-08-23

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TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www. tu ev-s ued. de/ ce rtifi cate-va I i d ity-ch eck

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12 100 24126 TMS


Begion Euro~e

Fresenius Kabi France S.A.S. 6, Rue du Rempart, BP 611 Production of LiqUid Pharmaceuticals, 27 406 Louviers Irrigation Solutions and Nonactive Devices FRANCE

Fresenius Kabi France S.A.S. Zone industrielle Ecoparc 2,

Logistics of Medical Devices, 350 Allee de Ia Butte a Colas 27400 Heudebouville

Pharmaceuticals and Enteral Nutrition

FRANCE

Fresenius Vial S.A.S. Development and Production of

Le Grand Chemin 38590 Brezins

Active Medical Devices, Logistics,

FRANCE Sales and Marketing of Medical Devices

Calea UK Ltd Production of Patient-specific Solutions of Cestrian Court, Eastgate Way, Manor Park, Runcorn, Pharmaceuticals, Logistics, Sales and Marketing Cheshire, WA7 1 NT of Health Gare Products and Services GREAT BRITAIN including Technical Service

Fresenius Kabi Ltd. Logistics, Sales , Marketing and

Cestrian Court, Eastgate Way, Manor Park, Runcorn , Technical Service of Medicinal Products,

Cheshire, WA7 1 NT Enteral Nutrition and Medical Devices

GREAT BRITAIN

Fresenius Kabi Oncology Pie Lion Court, Farnharn Road Production and Logistics of Bordon GU35 ONF Liquid Pharmaceuticals GREAT BRITAIN

Fresenius Kabi Hellas A.E.E. 354 Messoghion Avenue Logistics, Sales and Marketing of 15341 Agia Paraskevi Athens Medicinal Products and Service GREECE

Fresenius Kabi Hungary Kft. 1025 Budapest Logistics, Sales, Marketing Szepvölgyi ut 6 and Technical Service HUNGARY

Fresenius Kabi Croatia d.o.o. Trg . J.F. Kennedya 6b Marketing of Medicinal Products, 10000 Zagreb Enteral Nutrition and Medical Devices CROATIA

($DAkkS - Deutsche


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TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www. tuev-sued .de/ cert ificate-va I i d ity-ch eck

Akkreditierungsstelle D-ZM-14143-01-QO

Management Service


12 100 24126 TMS


B.egioa Euroge

Fresenius HemoCare ltalia S.r.l. Via San Pietro 1 Development and Production of 41 037 Mirandola Nonactive Medical Devices ITALY

Fresenius Kabi ltalia S.r.l. Production of Liquid Pharmaceuticals and

Via Camagre, 41 Nonactive Medical Devices, Logistics, Sales and

37063 lsola della Scala Marketing of Medicinal Products, Enteral Nutrition,

ITALY Medical Devices and Other Health Gare Products Services including Technical Service

Societa Chimica Mugello s.r.l. Via E. Mattei, 26 Production of 50039 Vicchio, (FI) Active Pharmaceuticallngredients ITALY

Fresenius HemoCare Netherlands B.V. Runde ZZ 41 7881 HM Emmer-Gompascuum NETHERLANDS

Fresenius Kabi Nederland B.V. Amersfoortseweg 1 0 E 3705GJ Zeist (Huis ter Heide) NETHERLANDS

Fresenius Kabi Norge AS Svinesundsveien 80 1788 Halden NORWAY

Fresenius Kabi Norge AS Gjerdrums vei 12 0484 Oslo NORWAY

Clinico Medical Sp. Z o.o. Bionie k I Wroclawia ul. Roberta Kocha 1, Bionie 55-330 Miekinia PO LAND

Development and Production of Nonactive Medical Devices

Logistics, Sales and Marketing of Medicinal Products, Enteral Nutrition, Medical Devices, Other Health Gare Products and Services

Production of Liquid Pharmaceuticals, Nonactive Medical Devices and Irrigation Solutions, Logistics, Sales and Marketing of Medicinal Products, Enteral Nutrition and Medical Devices

Sales and Marketing of Medicinal Products, Enteral Nutrition and Medical Devices and Services including Technical Service

Production of Nonactive Medical Devices

Product Gompliance Management Munich, 2017-08-23

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(~ DAk!~tsche Akkreditierungsstelle D-ZM-14143-01-00

TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www. tuev-sued .d e/ certificate-va I i d ity-check

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12 100 24126 TMS

Sites

B.egion EucoiJe

Fresenius Kabi Polska Sp. z o.o. Al. Jerozolimskie 134 02-305 Warszawa POLAND

Fresenius Kabi Polska Sp. z o.o. Sienkiewicza 25 99-300 Kutno PO LAND

DOM Medica Sp. z o.o. Al. Jerozolimskie 134 02-305 Warszawa PO LAND

Labesfal - Laborat6rios Almiro S.A. Zona lndustrial do Lagedo 3465-157 Santiago de Besteiros PORTUGAL

Fresenius Kabi Pharma Portugal Ltda Av. Do Forte 3, Edificio Suecia 4, Piso 3 2794-039 Carnaxide PORTUGAL

S.C. Fresenius Kabi Romania S.R.L. Strada Fanarului 2 A 500464 Brasov ROMANIA

Fresenius Kabi AB Kraftvägen 1 196 37 Kungsängen SWEDEN

Fresenius Kabi AB Rapsgatan 7 751 74 Uppsala SWEDEN

Fresenius Kabi AB Bredgränd 14 751 74 Uppsala SWEDEN



Production and Logistics of Liquid Pharmaceuticals

Horne enteral nutrition, Horne parenteral nutrition, Provision of long-term home care for mechanically ventilated patients, Provision of long-term home care for mechanically ventilated children, Provision for mechanically ventilated patients in the Care & Attendance/ Health Care Centers, Provision for mechanically ventilated children in the Care & Attendance/ Health Care Centers

Production of Pharmaceuticals (Solid, Sem i-solid, Liquids ), Medical Device Solutions and Other Health Care Products, Logistics, Sales and Marketing of Medicinal Products and Medical Devices

Logistics, Sales· and Marketing of Medicinal Products, Enteral Nutrition and Medical Devices

Logistics, Sales and Marketing of Medicinal Products, Enteral Nutrition and Medical Devices

Production and Logistics of Liquid Pharmaceuticals and Active Pharmaceuticallngredients

Design & Production of Parenteral Solutions as Lipid Emulsions, Clinical Nutrition, Anaesthetics, Vitamins

Logistics, Sales and Marketing of Medi.cinal Products, Enteral Nutrition, Medical Devices and Other Health Care Products and Services including Technical Service


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(~ DAk~~tsche Akkreditierungsstelle D-ZM-14143-01-00

TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www. tuev-s ued _ de/ certi fi cate-va I i d ity-ch eck

TUV®

Management Service


12100 24126 TMS


B.egioa Eucopß

Fresenius Kabi llac Sanayi ve Ticaret Ltd. Sirketi Güney Plaza Eski Büyükdere Asfalt1 No:

Logistics, Sales and Marketing of 17 /4B Kat:2, Maslak 34398 lstanbul Medicinal Products and Enteral Nutrition

TURKEY

B.egjoa Mrica

Fresenius Kabi Manufacturing SA (Pty) Ltd. 6 Gibaud Road, Karsten Produclien of 6020 Port Elizabeth Liquid Pharmaceuticals REPUBLIG OF SOUTH AFRIGA

Fresenius Kabi South Africa (Pty) Ltd. Produclien of Patient-specific Salutions of Stand 7, Growthpoint Park, 2 Tonetti Street Pharmaceuticals, Logistics, Sales and Marketing 1685 Midrand, Gauleng of Medicinal Products, Enteral Nutrition REPUBLIG OF SOUTH AFRIGA and Medical Devices

B.egioa l!sia E!.ac.ific_

Fresenius Kabi Australia Pty Limited Logistics, Sales and Marketing of Level 2, 2 Woodland Way

Mt Kuring-Gai, NSW 2080 Medicinal Products, Medical Devices and

AUSTRALIA Other Health Gare Products and Services

Fresenius Kabi Australia Pty Limited Logislies of Medicinal Products, 51 Sarah Andrews Glose

NSW 2759 Erskine Park Enteral Nutrition and Medical Devices

AUSTRALIA and Services including Technical Service

((C DAk~~sche Product Gompliance Management

Munich, 2017-08-23

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TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www. tuev-s ued. de/ ce rtificate-va I i d ity-check

Akkreditierungsstelle D~ZM·l4143-0l-OO

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12 100 24126 TMS


Eleg_ion l:!sia eac.ific

Fresenius Kabi (Nanchang) Co., Ltd. Qing Lan Road Nanchang Economic &

Production and Logistics Technological Development Zone Nanchang, Jiangxi Province, P.R. CHINA of Nonactive Medical Devices

Post Code: 330013

Fresenius Kabi (China) Co. Ltd. 16F, GrandyVIC Building,

Logistics, Sales and Marketing of No. 16 Taiyanggong Mid Street Chaoyang District, Beijing, P.R. CHINA Medical Devices

Post Code: 100028

Beijing Fresenius Kabi Pharmaceutical Co., Ltd. 16F, GrandyVIC Building,

Sales and Marketing of No. 16 Taiyanggong Mid Street Chaoyang District, Beijing, P.R. CHINA Medicinal Products

Post Code: 1 00028

Beijing Fresenius Kabi Pharmaceutical Co., Ltd. Production and Logistics of

No. 2 Shuangqiao East Rd. , Chaoyang District Beijing, P.R. CHINA Liquid and Solid Pharmaceuticals

Post Code: 100121 and Enteral Nutrition

Fresenius Kabi (Guangzhou) Co., Ltd. No.43 Baoying Street . Production of Nonactive Medical Devices Guangzhou Free Trade Zone, P.R. CHINA and liquid Medicinal Products Post Code: 510730

Development, Manufacturing and Supply of Fresenius Kabi SSPC Freeze-Dried Products, Large Volume Parenteral No. 16, Beizha Road, Mashan, Binhu District, Products, Small Volume Parenteral Products, Wuxi City, Jiangsu Province, P. R. China Enteral Products, Tablet Products (According Post Code: 214092 to the Drug Approval Numbers), Medical Devices

and Active Pharmaceutical lngredients

Fresenius Kabi Hong Kong Ltd. Sales and Marketing of 50/F Sun Hung Kai Centre, 30 Harbour Road

Wanchai, Hong Kong Medicinal Products, Enteral Nutrition,

P.R. CHINA Medical Devices and Service

Fresenius Kabi Asia Pacific Ltd. (The Representative Office of Fresenius Kabi Asia Pacific Limited in Ho Chi Minh City)

Marketing of Medicinal Products, 19/F, Harbour View Tower, 35 Nguyen Hue Blvd, District 1 Enteral Nutrition and Medical Devices

Ho Chi Minh City VIETNAM

(~ D~k!~sche Product Compliance Management

Munich, 2017-08-23


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TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www. tuev-su ed .de/ certifi cate-va I id ity-check

lUV®

Management Service

Sites

Region Asia Pacific


12 100 24126 TMS


Sales and Marketing of Medicinal Products, Fresenius Kabi Bidiphar JSC Harbour View Tower, 19th Floor 35 Nguyen Hue Street, Distriel 1 Ho Chi Minh City

Enteral Nutrition and Medical Devices and Services including Technical Service

VIETNAM

Fresenius Kabi Bidiphar JSC Zone 8, Nhon Phu Ward Quy Nhon, Binh Dinh VIETNAM

PT. Fresenius Kabi lndonesia Menara Bidakara 1, 19th Fl., Jl. Jend. Gatot Subroto, Kav. 71-73 Jakarta 12870 INDONESIA

Fresenius Kabi lndia Private Ltd. Fifth Floor, Ashoka Plaza, Survey.no.32/2, Pune- Nagar Road, Vimannagar Pune- 411014 IN DIA

Fresenius Kabi lndia Private ltd.

Production of Liquid Pharmaceuticals


Logistics, Sales, Marketing and Technical Service

Manufacture, Testing and Supply of A-3, MIDC. Ranjangaon Ganpati, Tai.-Shirur Dist. Pune - 412220 IN DIA

Large Volume Parenterals (LVPs) Belanging to Pharmaceutical Formulations

Fresenius Kabi Oncology Limited D-35, lndustrial Area Kalyani -741235, Dist. Nadia, West Bengal IN DIA

Fresenius Kabi Oncology Limited Viilage- Kishanpura, P.O. Guru Majra Tehsil- Nalagarh- 174101, Dist. Solan, (H.P.) IN DIA

Fresenius Kabi Oncology Limited 19, HPSIDC, lndustrial Area Baddi- 173205, Dist. Solan, (H.P.) IN DIA

Fresenius Kabi Oncology Limited Echelon lnstitutional Area, Plot No. 11, Sector- 32 Gurgaon - 122001, Haryana IN DIA

Production of Active Pharmaceuticallngredients

Technology Transfer and Manufacture of Liquid and Solid Pharmaceuticals

Manufacture of Liquid and Solid Pharmaceuticals

Development and Technology Transfer of Liquid and Solid Pharmaceuticals and Active Pharmaceutical lngredients

{~ DAk~~"h• Product Compliance Management

Munich, 2017-08-23

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TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www. tuev-su ed .de/ certif i cate-va I id ity-check

Akkreditierungsstelle D-ZM-14143..-01-00

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12 100 24126 TMS

Sites

Region Asia Pacific

Fresenius Kabi Japan K.K. 3F Toranomon 40MT Building, 5-1·3-1, Toranomon, Minato-ku, Tokyo 105-0001 JAPAN

Fresenius Kabi Korea Ltd. 17F East Wing IT Venture Tower 135 Jungdae-ro Songpa-Gu 138-950 Seoul REPUBLIC OF KOREA

Fresenius Kabi Malaysia Sdn Bhd. # 3-1 & 3-2, Axis Technology Centre, Lot 13, Jalan 51N225 46100 Petaling Jaya, Seianger MALAYSIA

Fresenius Kabi Philippines lnc. 18/F Aeon Center Bldg ., Northgate Cyberzone Alabang-Zapote Rd cor. Bridgeway Avenue, Filinvest City, Alabang, Muntinlupa City, 1781 REPUBLIC OF THE PHILIPPINES

Fresenius Kabi (Singapore) Pte Ltd. 150 Beach Road Gateway West #20-03/ 04 Singapore 189720 REPUBLIC OF SINGAPORE

Fresenius Kabi (Thailand) Ltd. 93/1 GPF Witthayu Tower B, 10th Floor, Room no.1001-1003, Wireless Road Lumpini , Pathumwan, BKK 10330 THAILAND

Fresenius Kabi Taiwan Ltd. 5F, No. 32, Section 3, Ren-Ai. Rd. 10653 Taipei TAIWAN

Region Latin Amerjca

Fresenius Kabi S.A. 2677 Cabildo Av. 1 oo Floor C1428AAU Buenos Aires ARGENTINA


Logistics, Sales and Marketing of . . Medicinal Products, Enteral Nutrition, Med1cal Dev1ces, Other Health Gare Products and Services

Sales and Marketing of Medicinal Products, Enteral Nutrition and Medical Devices and Services including Technical Services

Sales and Marketing of Medicinal Products, Enteral Nutrition, Medical Devices, Other Health Gare Products and Services including Technical Service

Logistics Sales and Marketing of Medicina'l Products, Enteral Nutrition, Medical Devices and Other Health Gare Products and Services including Technical Services

Sales and Marketing of Medicinal Products, Enteral Nutrition and Medical Devices

Logistics, Sales and Marketing of Medicinal Products, Medical Devices and Enteral Nutrition and Services including Technical Service

Sales and Marketing of Medicinal Products, Enteral Nutrition and Medical Devices and Services including Technical Services

Sales and Marketing of Medicinal Products, Enteral Nutrition, Medical Devices and Services

((l DAk~~"h• Product Compliance Management

Munich, 2017-08-23

Akkreditierungsste!le 0-ZM-14143-01-QO

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Management Service


12 100 24126 TMS


B.egjoa Latia Amer:ica

Nutri Horne S.A. 2677 Cabildo Av. 1 oo Floor

Sales of Services C1428AAU Buenos Aires ARGENTINA

Fresenius Kabi S.A. 1042 Serrano St. Production of Patient-specific Salutions Buenos Aires of Pharmaceuticals ARGENTINA

Fresenius Kabi S.A. Production of Patient-specific Salutions

Dei Comercio Boulevard 757 Cordoba

of Pharmaceuticals and

ARGENTINA Nonactive Medical Devices

IG Center S.R.L. Pringles St. 18 Production of Patient-specific Salutions Buenos Aires of Pharmaceuticals ARGENTINA

Fresenius HemoCare Brasil Ltda. Development and Production of

Rua Roque Gonzales, 128 Nonactive Medical Devices and

06855-690 ltapecerica da Serra - SP Other Health Care Products

BRAZIL

Fresenius HemoCare Brasil Ltda. Logistic, Sales, Marketing and

Av. Marginal Projetada, 1652, G1 A G8 Technical Service of Medical Devices

06460-200 Fazenda Tambore, Barueri- SP and Other Health Care Products

BRAZIL

Fresenius Kabi Brasil Ltda. Logistics, Sales and Marketing of Av. Marginal Projetada, 1652, G1 A G8 Medicinal Products, Enteral Nutrition

06460-200 Fazenda Tambore, Barueri - SP and Medical Devices BRAZIL

Fresenius Kabi Brasil Ltda. Production of Liquid Medicinal Products Rodeovia CE 040, S/No., Km 10 and Irrigation Salutionsand Logistics of 61700-000 Aquiraz-CE Medicinal Products, Enteral Nutrition BRAZIL and Medical Devices

(( DAk~~tsche Product Compliance Management

Munich, 2017-08-23

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TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www.tuev-sued.de/certif icate-validity-check

Akkreditlerungsstelle D-ZM-14143-01-00

1\JV®

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Management Service


12 100 24126 TMS


B.eg_ioa Latia Amecica

Gan Rio Apoio Nutricional - Ganutre Ltda. Rodevia Presidente Dutra N° 2.251,

Production of Patient-specific Salutions Galpäo 2 Armazem 102 Parque Columbia Vigario Geral. 21535-501 Rio de Janeiro-RJ of Pharmaceuticals

BRAZIL

HospPharma Manipulacao e Suprimentos Ltda. Rua Joaquim Nabuco, 265 Brooklin Paulista Production of Patient-specific Salutions 04621-002 Sao Paulo SP of Pharmaceuticals BRAZIL

Fresenius Kabi Chile Ltda. Logistics, Sales and Marketing of Pintor Cicarelli 235, San Joaquin Medicinal Products and Medical Devices 8940575 Santiaga and Services including Technical Service CHILE

Laboratorio Sanderson S.A. Garlos Fernandez 244 San Joaquin Production of Sterile Liquid Pharmaceuticals, 8940575 Santiaga Logistics and Sales of Medicinal Products CHILE

Recetario Magistral Endovenoso S.A. lgnacio Valdivieso 2361 Production, L_ogistics and Sales of 8940575 Santiaga Patient-specific Salutions of Enteral Nutrition CHILE

Recetario Magistral Endovenoso S.A. Calle Dos 1942 Production of Patient-specific Salutions Parque lndustrial, Concepci6n of Pharmaceuticals CHILE

Fresenius Kabi Mexico S.A. de C.V. Production of Liquid Pharmaceuticals, Paseo del Norte 5300A "Guadalajara Technology Park" Logistics, Sales and Marketing of Carretera Guadalajara-Nogales Km 12.5

45010 San Juan Ocotan, Zapopan, Jalisco Medicinal Products, Enteral Nutrition

MEXICO and Medical Devices

Filaxis International S.A. Business Center - Local 208 - Oficina 001 Sales of Zonamerica, Montevideo Medicinal Products URUGUAY


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Sites

B.egioa Nodb Amecica

Calea Ltd. 7111A-6th Street S.E:, Calgary Alberta T2H 2M8 CANADA

Calea Ltd.


12 100 24126 TMS


Production of Patient-specific Salutions of Pharmaceuticals and Logistics

Production of Patient-specific Salutions of 2785 Skymark Avenue, Unit 2, Mississauga, Ontario L4W 4Y3

Pharmaceuticals, Logistics, Sales and Marketing of

CANADA

Calea Ltd. 4847 Levy Street, St. Laurent, Quebec H4R 2P9 CANADA

Calea Vancouver lnc. Unit 130-8061 Lougheed Hwy. Burnaby BC V5A 1W9 CANADA

Fresenius Kabi Canada Ltd. 45 Vogel! Road, Suite 200, Richmond Hili, Ontario L4B 3P6 CA NA DA

Calea Pharmacy Ltd. 41 Brockley Drive, Unit 12, Stoney Creek, Ontario L8E 3P1 CANADA

Fresenius Kabi USA, LLC Three Gorparate Drive Lake Zurich, IL 60047 USA

Fresenius Kabi USA, LLC 2020 Ruby Street Melrose Park, IL 60160 USA

Fresenius Kabi USA, LLC 3159 Staley Road Grand lsland, NY 14072 USA

Medicinal Products and Services

Logistics, Sales and Marketing of Medicinal Products and Services

Production of Patient-specific Salutions of Pharmaceuticals, Logistics, Sales and Marketing of Medicinal Products and Services

Logistics, Sales and Marketing of Medicinal Products

Production of Patient-specific Salutions of Pharmaceuticals and Logistics

Sales and Marketing of Medicinal Products, Enteral Nutrition, Medical Devices and Other Health Gare Products

Production and Logistics of Liquid and Lyophilized Pharmaceuticals and Medical Devices

Production and Logistics of Liquid and Lyophilized Pharmaceuticals and Medical Devices

#.~. ((( DAk!~tsche Product Compliance Management

Munich, 2017-08-23

of 15

Akkreditierungsstel!e D-ZM-14143-01-00

TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www. tuev-s ued. de/ ce rtifi cate-va I i d ity-ch eck

TUV®

Management Service

Sites

B.egioa f'J.o_rth ~mecic.a

Fresenius Kabi USA, LLC 600 Supreme Drive Bensenville, IL 60106 USA

Fresenius Kabi USA, LLC


12 100 24126 TMS


Logistics of Medicinal Products, Enteral Nutrition, Medical Devices and Other Health Care Products; Coordination of Third Party Manufacturing of Medicinal Products and Medical Devices

Development and Testing of 8045 Lamon Avenue, Suite 300

Liquid and Lyophilized Pharmaceuticals Skokie, IL 60077 USA

and Medical Devices

Fenwal, lnc. Design and Development, Distribution,

Three Corporate Drive Lake Zurich, IL 60047

Installation, Servicing and Repair of

USA the System Medical Devices

Fenwallnternational, lnc. Manufacture and Distribution of Carretera Sanchez Km 18.5, Disposable and Accessories for the Collection, Parque lndustrialltabo, Zona Franca lnd. de S.C.

91000 Haina Processing and Storage of Blood and Blood

Dominican Republic Components, and Electron-Beam Sterilization

Fenwallnternationallnc. Manufacture and Distribution of Camino Reallndustrial Park Road # 122 Disposables and Accessories for the Collection, 00683 San German Processing and Storage of Blood and Blood Puerto Rico Components; to lnclude Electron-Beam Sterilization

Fenwallnternationallnc. Manufacture of Medical Devices, Disposables, Road 357 Km 0.8 Solutions and Accessories for the Collection, 00606 Maricao Processing and Storage of Blood and Blood Puerto Rico Components: to include Moist Heat Sterilization

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Munich, 2017-08-23

Akkreditierungsstelle D-ZM-14143-01-QO

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TÜV SÜD Management Service GmbH • Zertifizierungsstelle • Ridlerstraße 65 • 80339 München • Germany www. tuev-s ued. de/ ce rtifi cate-va I i d ity-check

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