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 PARTNER
DELIVERING WHAT WE PROMISE WITH INTEGRITY, QUALITY AND SUPERIOR CUSTOMER SERVICE
Rachel L. Timberlake
Associate Director, Sales and Business Development
Jubilant HollisterStier LLC
790 Township Line Road, Suite 175, Yardley, PA 19067
Cell: +1 845.392.1909
E-mail: RTimberlake@jhs.jubl.com | Website: www.jubl.com
2
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
3
Jubilant Overview
4
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
5
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%
6
G l o b a l R e g u l a t o r y A p p r o v a l s
J u b i l a n t P h a r m a
7
D i v e r s i f i e d C a p a b i l i t i e s
J u b i l a n t P h a r m a
8
D i v e r s i f i e d C a p a b i l i t i e s
J 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, HollisterStier
Allergy is the number-one choice of
allergists around the world.
• Jubilant DraxImage Inc. develops,
manufactures and commercializes
radiopharmaceuticals used
for the diagnosis, treatment and
monitoring of disease.
9
D i s c o v e r y S e r v i c e s
J u b i l a n t L i f e S c i e n c e s
10
CMO Services
11
C M O H i s t o r y
J u b i l a n t H o l l i s t e r S t i e r
12
C M O S e r v i c e s - M o n t r e a l
J 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 Vials
Automated
Filing
Sterile
Ophthalmic
Solutions
Ointments
and
Creams
Robotic
tube
Feeder
CIP/SIP
High
Speed
Lines
13
C M O S e r v i c e s - M o n t r e a l
J 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
14
C M O S e r v i c e s - M o n t r e a l
J u b i l a n t H o l l i s t e r S t i e r
15
C M O S e r v i c e s - S p o k a n e
J 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
16
Inspection History
17
I n s p e c t i o n H i s t o r y
J u b i l a n t P h a r m a
Agency Jubilant Generics
US
Cadista
Salisbury,
Maryland, USA
US Generics Division
Cadista
India and ROW Generics Division
Jubilant Generics
Roorkee, Uttarakhandm, India
Contract Manufacturing
Division
HollisterStier
Spokane, Washington, USA
Contract Manufacturing Division
HollisterStier
Kirkland, Quebec, Canada
Radio Pharmaceutical Division
Draximage
Kirkland, Quebec, Canada
API Division
Nanjangud,
Karnataka, India
US FDA Aug-15 Mar-15
& Apr-16
Mar-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
19
S e r i a l i z a t i o n T i m e l i n e
J 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 - Cadista
Salisbury, Maryland, USA
1 Blister/ Cartoning Line Jun 2017
2 Bottle Line#1 Aug 2017
3 Bottle Line#2 Sep 2017
Contract Manufacturing Division - HollisterStier
Spokane, 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 - HollisterStier
Kirkland, 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 – Cadista
India and ROW Generics Division - Jubilant
Generics
Roorkee, Uttarakhandm, India 1 Blister line May 2017
2 Bottle line May 2017
20
Contact Us
21
C o n t a c t U s
J u b i l a n t P h a r m a
 Contract Manufacturing Division – Jubilant HollisterStier
Rachel L. Timberlake | Associate Director, Sales and Business Development
790 Township Line Road, Suite 175, Yardley, PA 19067
Cell: +1 845.392.1909
E-mail: RTimberlake@jhs.jubl.com | Website: www.jubl.com
 Generics Division USA - Cadista
Kevin Fortier | Senior Director of Sales
790 Township Line Road, Suite 175, Yardley, PA 19067
Cell: +1 215.534.8406
E-mail: Kevin.Fortier@cadista.com | Website: www.cadista.com
 Allergy Division USA – HollisterStier Allergy
Mary Miller | National Sales Director
3525 N. Regal St., Spokane, WA 99207
Cell: +1 209.740.3571
E-mail: Mary.Miller@jhs.jubl.com | Website: www.hsallergy.com/
 Radiopharmaceuticals Division – Draximage
Kevin Brooks| VP, Business Development
16751 Trans-Canada Highway, Kirkland, Quebec, H9H 4J4, Canada
E-mail: KBrooks@jdi.jubl.com | Website: www.draximage.com
 In-Licensing – Jubilant Pharma
Grace Shen, R.Ph.| VP of Generic Injectables, Specialty Pharmaceuticals
790 Township Line Road, Suite 175, Yardley, PA 19067
Cell: +1 980.297.3687
E-mail: grace_shen@jubl.com | Website: www.jubilantpharma.com
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C o n t a c t U s
J u b i l a n t L i f e S c i e n c e s
 API Division – Jubilant Life Sciences
Sourav Adak| Sr. Marketing Manager
790 Township Line Road, Suite 175, Yardley, PA 19067
Cell: +1 609.375.6831
E-mail: sourav_adak@jubl.com | Website: www.jubl.com
 Drug Discover Solutions – Jubilant Biosys Ltd.
Saurabh Kapure | Associate Vice President- Business Development
5050 Hacienda Dr, Dublin, CA 94568
Cell: +1 925.888.9113
E-mail: Saurabh_Kapure@jubilantbiosys.com | Website: www.jubilantbiosys.com
 Small Molecule Drug Discover Solutions – Jubilant Biosys Ltd.
Jayachandran Ezhuthachan | Senior Director - East Coast USA | Business Development
365 Phoenixville Pike, Malvern, PA 19355
Cell: +1 610.240.8690
E-mail: J_Ezhuthachan@jubilantbiosys.com | Website: www.jubilantbiosys.com

Jubilant Pharma Capabilities Presentation

  • 1.
    H A IR C A R E 2 0 1 6 C o l l e c t i o n Sept.,3rd 2015L’Oréal STRATEGIC OUTSOURCING PARTNER DELIVERING WHAT WE PROMISE WITH INTEGRITY, QUALITY AND SUPERIOR CUSTOMER SERVICE Rachel L. Timberlake Associate Director, Sales and Business Development Jubilant HollisterStier LLC 790 Township Line Road, Suite 175, Yardley, PA 19067 Cell: +1 845.392.1909 E-mail: RTimberlake@jhs.jubl.com | Website: www.jubl.com
  • 2.
    2 A G EN D A Jubilant Overview CMO Services Inspection History Serialization Update Contact Us M a r c h 2 0 1 7
  • 3.
  • 4.
    4 J u bi 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
  • 5.
    5 J u bi 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%
  • 6.
    6 G l ob a l R e g u l a t o r y A p p r o v a l s J u b i l a n t P h a r m a
  • 7.
    7 D i ve r s i f i e d C a p a b i l i t i e s J u b i l a n t P h a r m a
  • 8.
    8 D i ve r s i f i e d C a p a b i l i t i e s J 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, HollisterStier Allergy is the number-one choice of allergists around the world. • Jubilant DraxImage Inc. develops, manufactures and commercializes radiopharmaceuticals used for the diagnosis, treatment and monitoring of disease.
  • 9.
    9 D i sc o v e r y S e r v i c e s J u b i l a n t L i f e S c i e n c e s
  • 10.
  • 11.
    11 C M OH i s t o r y J u b i l a n t H o l l i s t e r S t i e r
  • 12.
    12 C M OS e r v i c e s - M o n t r e a l J 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 Vials Automated Filing Sterile Ophthalmic Solutions Ointments and Creams Robotic tube Feeder CIP/SIP High Speed Lines
  • 13.
    13 C M OS e r v i c e s - M o n t r e a l J 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
  • 14.
    14 C M OS e r v i c e s - M o n t r e a l J u b i l a n t H o l l i s t e r S t i e r
  • 15.
    15 C M OS e r v i c e s - S p o k a n e J 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
  • 16.
  • 17.
    17 I n sp e c t i o n H i s t o r y J u b i l a n t P h a r m a Agency Jubilant Generics US Cadista Salisbury, Maryland, USA US Generics Division Cadista India and ROW Generics Division Jubilant Generics Roorkee, Uttarakhandm, India Contract Manufacturing Division HollisterStier Spokane, Washington, USA Contract Manufacturing Division HollisterStier Kirkland, Quebec, Canada Radio Pharmaceutical Division Draximage Kirkland, Quebec, Canada API Division Nanjangud, Karnataka, India US FDA Aug-15 Mar-15 & Apr-16 Mar-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
  • 18.
  • 19.
    19 S e ri a l i z a t i o n T i m e l i n e J 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 - Cadista Salisbury, Maryland, USA 1 Blister/ Cartoning Line Jun 2017 2 Bottle Line#1 Aug 2017 3 Bottle Line#2 Sep 2017 Contract Manufacturing Division - HollisterStier Spokane, 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 - HollisterStier Kirkland, 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 – Cadista India and ROW Generics Division - Jubilant Generics Roorkee, Uttarakhandm, India 1 Blister line May 2017 2 Bottle line May 2017
  • 20.
  • 21.
    21 C o nt a c t U s J u b i l a n t P h a r m a  Contract Manufacturing Division – Jubilant HollisterStier Rachel L. Timberlake | Associate Director, Sales and Business Development 790 Township Line Road, Suite 175, Yardley, PA 19067 Cell: +1 845.392.1909 E-mail: RTimberlake@jhs.jubl.com | Website: www.jubl.com  Generics Division USA - Cadista Kevin Fortier | Senior Director of Sales 790 Township Line Road, Suite 175, Yardley, PA 19067 Cell: +1 215.534.8406 E-mail: Kevin.Fortier@cadista.com | Website: www.cadista.com  Allergy Division USA – HollisterStier Allergy Mary Miller | National Sales Director 3525 N. Regal St., Spokane, WA 99207 Cell: +1 209.740.3571 E-mail: Mary.Miller@jhs.jubl.com | Website: www.hsallergy.com/  Radiopharmaceuticals Division – Draximage Kevin Brooks| VP, Business Development 16751 Trans-Canada Highway, Kirkland, Quebec, H9H 4J4, Canada E-mail: KBrooks@jdi.jubl.com | Website: www.draximage.com  In-Licensing – Jubilant Pharma Grace Shen, R.Ph.| VP of Generic Injectables, Specialty Pharmaceuticals 790 Township Line Road, Suite 175, Yardley, PA 19067 Cell: +1 980.297.3687 E-mail: grace_shen@jubl.com | Website: www.jubilantpharma.com
  • 22.
    22 C o nt a c t U s J u b i l a n t L i f e S c i e n c e s  API Division – Jubilant Life Sciences Sourav Adak| Sr. Marketing Manager 790 Township Line Road, Suite 175, Yardley, PA 19067 Cell: +1 609.375.6831 E-mail: sourav_adak@jubl.com | Website: www.jubl.com  Drug Discover Solutions – Jubilant Biosys Ltd. Saurabh Kapure | Associate Vice President- Business Development 5050 Hacienda Dr, Dublin, CA 94568 Cell: +1 925.888.9113 E-mail: Saurabh_Kapure@jubilantbiosys.com | Website: www.jubilantbiosys.com  Small Molecule Drug Discover Solutions – Jubilant Biosys Ltd. Jayachandran Ezhuthachan | Senior Director - East Coast USA | Business Development 365 Phoenixville Pike, Malvern, PA 19355 Cell: +1 610.240.8690 E-mail: J_Ezhuthachan@jubilantbiosys.com | Website: www.jubilantbiosys.com