WHAT´S NEXT FOR STERILE CONTRACT MANUFACTURING IN EMERGING MARKETS?
Dr. Laura Pandolfi
Business Development Manager
Product Partnering Sterile Pharmaceuticals
Region Europe, LAM, Africa & AsiaCPhI woldwide 2018, MadridBooth 3C101
Agenda
▪ Introduction
▪ Fresenius Kabi Product Partnering
▪ Capabilities in Emerging Markets
▪ Summary
Agenda
▪ Introduction
▪ Fresenius Kabi Product Partnering
▪ Capabilities in Emerging Markets
▪ Summary
FRESENIUS KABI PRODUCT PARTNERING Fresenius Group Structure
Medicines and technologies for
infusion,transfusion and clinical nutrition
2017 sales € 6,3 billion*
Europe’s leading private hospital operator, with HELIOS and Quirónsalud
hospitals
2017 sales € 8,7 billion*
Products and services for people with
chronic kidney failure
2017 sales€ 17,8 billion*
Projects and services for
hospitals and other healthcare
facilities worldwide
2017 sales € 1,2 billion*
The Fresenius Group has more than 270,000 employees worldwide*© Copyright Fresenius Kabi AG 4* Fresenius Annual Report 2017
FRESENIUS KABI PRODUCT PARTNERINGFresenius Kabi Business Segments
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Clinical Nutrition I.V. Drugs Infusion Therapy BiosimilarsMedical Devices/
Transfusion
Technology
High-quality and affordable products for the therapy and
care of critically and chronically ill patients
in hospital and outpatient care
Agenda
▪ Introduction
▪ Fresenius Kabi Product Partnering
▪ Capabilities in Emerging Markets
▪ Summary
FRESENIUS KABI PRODUCT PARTNERINGOur CMO Service in a Nutshell
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▪ Contract development and manufacturing services of
sterile medicinal products and medical devices to the
pharmaceutical industry
▪ Access to the capabilities and competencies of more
than 20 Fresenius Kabi manufacturing facilities and
innovation centers worldwide
▪ Decades of experience in manufacturing sterile
pharmaceuticals and medical devices
Fresenius Kabi Product Partnering is a business-to-business platform dedicated to
contract manufacturing services offering:
FRESENIUS KABI PRODUCT PARTNERING Your Partner for Solutions
© Copyright Fresenius Kabi AG 8
CONTRACT MANUFACTURING
SERVICES FOR:
PRE-FILLED SYRINGES
glass, COC: 0,5 – 50 mL
VIALS
glass, PP: 1 – 50 mL
IV-BAGS
PP, PVC etc.: 50 – 5.000 mL
AMPOULES
glass, PP, PE: 1 – 30 mL
BOTTLES
glass, PP, PE: 50 – 1.000 mL
FRESENIUS KABI PRODUCT PARTNERINGGlobal Manufacturing Network for Sterile Pharmaceuticals
• 8 Plants in Europe (5FDA certified)
• 3 FDA certified Plantsin North America
• 4 Plants in LatinAmerica
• 3 Plants in Asia
• 1 Plant in Africa
FRESENIUS KABI PRODUCT PARTNERINGTechnical Capabilities
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▪ Formulation Development
▪ Design Delivery Systems
▪ Manufacturing of clinical trial medication
▪ Process scale up from bench to commercial scale
▪ Commercial Scale fill/finish
▪ Worldwide shipping and distribution
▪ Supporting Activities:
• Procurement of Ingredients,
• Laboratory Services,
• ICH-Stability Studies, Regulatory Assistance
FRESENIUS KABI PRODUCT PARTNERINGFill & Finishing Technologies
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▪ Aseptic filling
▪ Terminal Sterilization
▪ Solutions
▪ Disperse systems (emulsions and suspensions)
▪ Handling of "potent" API
▪ Lyophilization
FRESENIUS KABI PRODUCT PARTNERINGContainers I
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▪ Prefilled Syringes
▪ Vials
Glass / COC 0.5 – 50 ml
Glass / PP1 – 50 ml
FRESENIUS KABI PRODUCT PARTNERINGContainers II
© Copyright Fresenius Kabi AG 13
▪ (IV-) Bags
▪ Ampoules
PP / PVC / … 50 – 5,000 ml
Glass / PP / PE 1 - 30 ml
FRESENIUS KABI PRODUCT PARTNERINGContainers III
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▪ Bottles
▪ Customized Systems
Glass / PP / PE 50 – 1,000 ml
Multi-chamber bags
Pillow bags
Cassettes
Irrigating systems
Agenda
▪ Introduction
▪ Fresenius Kabi Product Partnering
▪ Capabilities in Emerging Markets
▪ Summary
© Copyright Fresenius Kabi AG 16
FRESENIUS KABI PRODUCT PARTNERINGOpportunities in Emerging Markets
Healthcare spending in Indonesia amounted to 30.2 bn$ in 2017 and projected to rise to
47.1 bn$ by 2022 and to 78.0 bn$ by 2027, at a 10-year annual growth rate of 10.0% (1).
Healthcare spending in Brazil in 2016 was $193 billion and it is anticipated to grow at a
CAGR of around 5.8% during 2016-2020 (2).
Factors:
Annual GDP growth per capita in Brazil: 12.9%
Percentage of people aged 15-64 in Brazil: 69% (3)
Annual GDP growth in Indonesia in 2017: 7.6%
Percentage of people aged 15-64 in Indonesia: 67% (3)
(1) HEALTHCARE ASIA Staff Reporter, Indonesia (20 Apr 18)(2) export.gov. Brazil – Healthcare (Oct 2017)(3) Emergo. Health Care Spending By Country (Jul 2016)
With huge populations, increasing prosperity, and improving longevity as well as effort
from the governments to improve health policy and healthcare in the countries, emerging
markets represent the “promised land” of the pharmaceutical industry(1) but it comes with
challenges:
➢ Drug shortage and insufficient resources
➢ Limited capacity
➢ Lack of expertise
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FRESENIUS KABI PRODUCT PARTNERINGChallenges in Emerging Markets
(1) Mc Kinsey & Company. Accelerating access in emerging markets: Pharma’s next big launch challenge (Jul 2015)(2) Mordor Intelligence. Asia-Pacific Pharmaceutical Contract Manufacturing Market (2016 - 2021)
In Brazil the government gives preference to locally manufactured products(1)
In Indonesia the majority of drugs should be manufactured domestically for approval(2)
▪ We provide local manufacturing in Indonesian and Brazilian facilities
▪ We have experienced teams
▪ We offer customized services
▪ We are a One-Stop-Shop
▪ We provide assistance for global commercial supply
▪ Our GQM system guarantees compliance with national and international requirements
▪ We have collected expertise globally that our customers can benefit from
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FRESENIUS KABI PRODUCT PARTNERINGThe advantages of partnering with us in Indonesia and Brazil
FRESENIUS KABI PRODUCT PARTNERING Plant Jababeka, Indonesia
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CAPABILITIES PRODUCTS
▪ SVP Aseptic Filling(Ampoules & Vials)
▪ SVP Terminal Sterilised Filling (Ampoules & Vials)
▪ Light Sensitive Products
▪ Oxygen Sensitive Products
▪ Ketorolac
▪ Oxytocin
▪ Methylergo Maleate
PRIMARY PACKAGING
▪ BPOM (National Agency for Drug and Food Control)
▪ Glass Ampoules (1-10 mL)
▪ Glass Vials (2-10 mL)
CERTIFICATES
FRESENIUS KABI PRODUCT PARTNERING Plant Anápolis, Brazil
© Copyright Fresenius Kabi AG 20
CAPABILITIES PRODUCTS
▪ Aseptic Filling
▪ Terminal Sterilization
▪ Onsite warehouse
▪ I&D Center Latin America
▪ Small Molecules
▪ Antibiotics
▪ Glucocorticoids
▪ Analgesics
▪ Catecholamine
PRIMARY PACKAGING
▪ ANVISA
▪ GAFO
▪ Glass Ampoules (1-10 mL)
▪ Glass Vials (0.1-5 g)
CERTIFICATES
FRESENIUS KABI PRODUCT PARTNERING Plant Aquiraz, Brazil
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CAPABILITIES PRODUCTS
▪ Liquid PE Bottle Filling (KabiPac®)
▪ BFS technology
▪ Terminal sterilization
▪ Standard Solutions
▪ IV drugs
▪ Colloids
PRIMARY PACKAGING
▪ ANVISA
▪ ISO 9001:2015
▪ KabiPac®
▪ Canister
CERTIFICATES
Agenda
▪ Introduction
▪ Fresenius Kabi Product Partnering
▪ Capabilities in Emerging Markets
▪ Summary
FRESENIUS KABI PRODUCT PARTNERING Summary
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▪ We have collected expertise globally that ourcustomers can benefit from
▪ World-class quality and regulatory systems withexcellent track record
▪ We balance our global competences with tailoredapproaches for local markets
▪ Increased presence in emerging markets with localfacilities and customer relationships
▪ We help you overcoming regulatory challenges inemerging markets
FRESENIUS KABI PRODUCT PARTNERINGContact Us
© Copyright Fresenius Kabi AG
+49 6172 686 1240 [email protected]
cmo.fresenius-kabi.com
Fresenius Kabi Product Partnering has a highly educated and dedicated team of
international experts with many years of experience in the Pharmaceutical industry.
We welcome you to contact us to discuss about the perfect solution for you and your
product!
LEGAL DISCLAIMER: This presentation includes and reflects the personal experience, thoughts and opinion of the presenter only. The content and views presented hereafter are based on various travels to Asian
and Latin American countries, meetings at local sites as well as with customers and overall encounters and challenges met during these occasions.The summary of this presentation may therefore in parts or in
full not reflect the overall position or company policy of Fresenius Kabi Deutschland GmbH or Fresenius Kabi as a whole, who are therefore not responsible for the content rendered in the following slides.
FRESENIUS KABI CONTRACT MANUFACTURINGNew name, same partner
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