jubilant pharma capabilities presentation
TRANSCRIPT
H A I R C A R E 2 0 1 6 C o l l e c t i o n
Sept.,3rd 2015L’Oréal
STRATEGIC OUTSOURCING PARTNERDELIVERING WHAT WE PROMISE WITH INTEGRITY, QUALITY AND SUPERIOR CUSTOMER SERVICE
Rachel L. TimberlakeAssociate Director, Sales and Business Development
Jubilant HollisterStier LLC790 Township Line Road, Suite 175, Yardley, PA 19067
Cell: +1 845.392.1909E-mail: [email protected] | Website: www.jubl.com
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A G E N D A
Jubilant Overview
CMO Services
Inspection History
Serialization Update
Contact Us
M a r c h 2 0 1 7
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Jubilant Overview
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J u b i l a n t B h a r t i a G r o u p
A D i v e r s i f i e d $ 3 B i l l i o n B u s i n e s s
Ophtha. ++ Non-sterile
FY 2017 ~$900 million
FY 2017 ~$500 million
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J u b i l a n t L i f e S c i e n c e s
Sterile Ophthalmic, Non-sterile liquids and semi-solids
55%45%
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G l o b a l R e g u l a t o r y A p p r o v a l sJ u b i l a n t P h a r m a
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D i v e r s i f i e d C a p a b i l i t i e sJ u b i l a n t P h a r m a
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D i v e r s i f i e d C a p a b i l i t i e sJ u b i l a n t P h a r m a
• With nearly 100 years of leadership in research, extract production, and immunotherapy products, HollisterStierAllergy is the number-one choice of allergists around the world.
• Jubilant DraxImage Inc. develops, manufactures and commercializes radiopharmaceuticals usedfor the diagnosis, treatment and monitoring of disease.
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D i s c o v e r y S e r v i c e sJ u b i l a n t L i f e S c i e n c e s
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CMO Services
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C M O H i s t o r yJ u b i l a n t H o l l i s t e r S t i e r
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C M O S e r v i c e s - M o n t r e a lJ u b i l a n t H o l l i s t e r S t i e r
Key Figures 240,000 sq. ft. facility 300 Full-time employees 5 million units 120 SKUs Distributing to over 50 different countries
Non-Sterile
Ointments & Creams
Liquids & Suspensions
Flexible Packaging
Sterile Parenteral
Liquid Vials
Lyo VialsAutomated
Filing
Sterile Ophthalmic
Solutions
Ointments and
Creams
Robotic tube
FeederCIP/SIP
High Speed Lines
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C M O S e r v i c e s - M o n t r e a lJ u b i l a n t H o l l i s t e r S t i e r
Ophthalmic Filling Non-Sterile Filling
Liquids High speed ophthalmic solution line LDPE and Polypropylene 5mL – 10mL 3-piece bottles
Semi-solids 4.5g plastic laminate and 3.5g aluminum
tubes Robotic tube feeder
Computerized batching CIP/SIP system
3 manufacturing suites for semi-solids and 2 manufacturing suites for liquids
Oxygen, heat and light sensitive products Current volume capability ranges from 1,000 –
18,000L for liquids and 500 –1100kg for ointments and creams
Tubes: 9g –108g Bottles: 40ml –2L Applicators: 2.5ml, 5ml Jars: various
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C M O S e r v i c e s - M o n t r e a lJ u b i l a n t H o l l i s t e r S t i e r
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C M O S e r v i c e s - S p o k a n eJ u b i l a n t H o l l i s t e r S t i e r
Key Figures 192,000 sq. ft. facility 400 Full-time employees 40 million units 26 SKUs Distributing to over 50 different countries
Products Small Molecule Biologics – Proteins WFI – Diluents Liposomes Oligonucleotides Vaccines
Sterile Parenteral
Clinical Trial Phase I -
Commercial
Lyo Vials
Automated Filing
Liquid Vials
Liquid Vial Filling Lyo Vial Filling 385 ft2 Capacity
2 High-speed lines 400 vial/min Diaphragm pump technology Oxygen reduction system 2mL – 100mL
-45°C cold shelf loading 160 vial/min (2) 385 ft2, (2) 240 ft2, (2) 30
ft2 Chambers 2mL – 100mL
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Inspection History
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I n s p e c t i o n H i s t o r yJ u b i l a n t P h a r m a
Agency Jubilant GenericsUS
CadistaSalisbury,
Maryland, USA
US Generics DivisionCadista
India and ROW Generics DivisionJubilant Generics
Roorkee, Uttarakhandm, India
Contract Manufacturing Division
HollisterStierSpokane, Washington, USA
Contract Manufacturing Division HollisterStier
Kirkland, Quebec, Canada
Radio Pharmaceutical Division Draximage
Kirkland, Quebec, Canada
API DivisionNanjangud,
Karnataka, India
US FDA Aug-15 Mar-15& Apr-16Mar-17
Mar-14, Nov-14, Dec-14, Jul-15 & Sept-16,
Nov-16
Dec-15,Dec-16 Dec-15, Jan-17 Oct-15
Health Canada
Jan-09 Mar-14, May-14 & Sep-15 Oct-14, Nov-14 & Apr-16
MCC SA Feb-15
MHRA UK May-14 June-13, Mar-17
ANVISA Brazil
Aug-08 Jun-16 Mar-15 & May-16
Turkish Auth.
Mar-15 Mar-15
MOH Yemen
Aug-14
Kenya MOH Oct-15
MOH Taiwan
Jan-15
PMDA Japan
Dec-15 Jan-17 May-16
COFEPRIS –Mexico
Aug-15
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Serialization
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S e r i a l i z a t i o n T i m e l i n eJ u b i l a n t P h a r m a
Location No. Name of Line Validated and Go-Live
US Generics Division - CadistaSalisbury, Maryland, USA
1 Blister/ Cartoning Line Jun 2017
2 Bottle Line#1 Aug 2017
3 Bottle Line#2 Sep 2017
Contract Manufacturing Division - HollisterStierSpokane, Washington, USA
1 SVP Pack 1 – CMO/Diluents Sep 2017
2 SVP Pack 2- CMO Sep 2017
3 ABU - Finishing July 2017
Contract Manufacturing Division - HollisterStierKirkland, Quebec, Canada
1 Pkg line 2 Sep 2017
2 Pkg line 3 Sep 2017
3 Pkg line 3a Sep 2017
4 Pkg line 5 Sep 2017
5 Pkg line 6 Sep 2017
US Generics Division – CadistaIndia and ROW Generics Division - Jubilant GenericsRoorkee, Uttarakhandm, India 1 Blister line May 2017
2 Bottle line May 2017
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Contact Us
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C o n t a c t U sJ u b i l a n t P h a r m a
Contract Manufacturing Division – Jubilant HollisterStierRachel L. Timberlake | Associate Director, Sales and Business Development790 Township Line Road, Suite 175, Yardley, PA 19067Cell: +1 845.392.1909E-mail: [email protected] | Website: www.jubl.com
Generics Division USA - CadistaKevin Fortier | Senior Director of Sales 790 Township Line Road, Suite 175, Yardley, PA 19067Cell: +1 215.534.8406 E-mail: [email protected] | Website: www.cadista.com
Allergy Division USA – HollisterStier AllergyMary Miller | National Sales Director3525 N. Regal St., Spokane, WA 99207 Cell: +1 209.740.3571E-mail: [email protected] | Website: www.hsallergy.com/
Radiopharmaceuticals Division – DraximageKevin Brooks| VP, Business Development16751 Trans-Canada Highway, Kirkland, Quebec, H9H 4J4, CanadaE-mail: [email protected] | Website: www.draximage.com
In-Licensing – Jubilant PharmaGrace Shen, R.Ph.| VP of Generic Injectables, Specialty Pharmaceuticals790 Township Line Road, Suite 175, Yardley, PA 19067Cell: +1 980.297.3687E-mail: [email protected] | Website: www.jubilantpharma.com
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C o n t a c t U sJ u b i l a n t L i f e S c i e n c e s
API Division – Jubilant Life SciencesSourav Adak| Sr. Marketing Manager 790 Township Line Road, Suite 175, Yardley, PA 19067Cell: +1 609.375.6831E-mail: [email protected] | Website: www.jubl.com
Drug Discover Solutions – Jubilant Biosys Ltd.Saurabh Kapure | Associate Vice President- Business Development 5050 Hacienda Dr, Dublin, CA 94568Cell: +1 925.888.9113E-mail: [email protected] | Website: www.jubilantbiosys.com
Small Molecule Drug Discover Solutions – Jubilant Biosys Ltd.Jayachandran Ezhuthachan | Senior Director - East Coast USA | Business Development365 Phoenixville Pike, Malvern, PA 19355Cell: +1 610.240.8690 E-mail: [email protected] | Website: www.jubilantbiosys.com