avara pharmaceutical services corporate presentation corporate final... · 2019. 10. 31. ·...
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avara.comCompany Confidential
AVARA PHARMACEUTICAL SERVICESCORPORATE PRESENTATION
avara.com | 2Company ConfidentialCompany Confidential
Avara Pharmaceutical Services is a CMO whose goal is to deliver a world-class outsourcing experience to our customers
▪ We strive to consistently deliver on all commitments, “On Time, In Full,
and at a Fair Price.”
▪ We offer a global network of world-class facilities, with proven commercial
records, to meet the highest quality and reliability standards.
▪ By valuing and retaining long-tenured staff, we ensure institutional
expertise and knowledge.
▪ Our flexibility allows us to tailor our services to your needs.
▪ We create trust through transparent communication.
Our Mission
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Corporate Overview
▪ All global operations are managed from this facility.
▪ Our lean corporate structure ensures
greater customer value.
▪ Our site management teams work closely
with each other via our global network.
NORMAN, OKLAHOMA (HQ)Norman, Oklahoma – Corporate Headquarters
Avara: By The Numbers
▪ Total Headcount: ~930
▪ Current Customers: >50
▪ Current SKUs: >500
▪ Markets Served: >100
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Quality Elements
Quality Policies
SOPs, Work Instructions,
Batch Records, Forms
RegulationsIndustry Trends &
Best Practices
Avara Quality System: QMS / GMP Framework
Global Quality Management Systems (GMP) Framework compliant with FDA, ICH, and all other applicable Regulatory Authorities.
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Capabilities Overview
▪ Solid dose drug product: Including
potent and controlled substances, spray
drying, small batch, and OTC.
▪ Parenteral drug product: Including
aseptic fill into vials & ampoules, terminal
sterilization, and lyophilization.
▪ Packaging: Primary, secondary, global
distribution, and supply chain support.
Avara offers broad experience in
pharmaceutical product transfers,
commercialization, and launch.
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LISCATEITALY►STERILE MANUFACTURING & DRUG PRODUCT PACKAGING
(LYOPHILIZED & SVP)
ARECIBOPUERTO RICO► ORAL SOLID DOSAGE
MANUFACTURING & PACKAGING
► CONTROLLED SUBSTANCES CII & CIII
AIKENSOUTH CAROLINA► ORAL SOLID DOSAGE
MANUFACTURING & PACKAGING
NORMANOKLAHOMA,USA► HQ
► ORAL SOLID DOSAGE
MANUFACTURING & PACKAGING
REIMSFRANCE►ORAL SOLID DOSAGE PACKAGING
►PRIMARY & SECONDARY DISTRIBUTION OF All
PHARMACEUTICAL DOSAGE FORMS
Avara Pharmaceutical Services
Our Global Footprint
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▪ Acquired from Merck & Co.
▪ Over 35 years of site experience
▪ Manufactures multiple commercial products, including blockbusters
▪ Wet granulation & drying
▪ Sphere / pellet coating
▪ Extrusion
▪ Compression, encapsulation, film coating
▪ Packaging in plastic bottles
▪ Scheduled drugs CII & CIII
Arecibo, Puerto RicoFacility Overview
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Aiken, South Carolina
Facility Overview
▪ Acquired from GSK
▪ Over 39 years of site experience
▪ Multiple successful Rx to OTC switches
▪ Tablets, capsules, & lozenges
▪ Wet granulation, fluid bed granulation & drying
▪ Compression, coating, & printing
▪ Packaging into blister, bottle
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Norman, Oklahoma
SHANNON, IRELANDFacility Overview
▪ Acquired from Astellas Pharma
▪ Over 35 years of site experience
▪ Manufactures six commercial products,
including two blockbusters
▪ Clinical to commercial-scale supply
▪ Tablets, capsules, & sachets
▪ Spray drying
▪ Wet granulation, fluid bed granulation, & drying
▪ Compression, coating, printing
▪ Packaging in blisters, bottles, & vials
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Reims, France
Facility Overview
▪ Acquired from AstraZeneca
▪ Over 45 years of site experience
▪ Packaging & distribution center of excellence
▪ Packaging site for two drug blockbusters
▪ Seven automated packaging lines with
finished space for additional lines
▪ Distribution to wholesalers, hospitals &
pharmacies
▪ Packaging development capabilities
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Liscate, Italy
Facility Overview
▪ Acquired from Pfizer
▪ Proven track record as a contract manufacturer
▪ €30 million of investment since 2009
▪ Lyophilization > 90 sq. M
▪ Aseptic filling and terminal sterilization
▪ Aseptic powder filling into vials
▪ Multi-country labelling, finishing and serialization
▪ Development labs and small-scale equipment
▪ High containment capabilities
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Capabilities Matrix - OSD
Location
Co
ntr
oll
ed
Su
bst
an
ces
Mil
lin
g
Ble
nd
ing
Dry
Gra
nu
lati
on
(Po
wd
er
Mix
ture
s)
Wet
Gra
nu
lati
on
Dry
ing
Co
mp
ress
ion—
Sin
gle
,
Bi, -
& T
ri-
Layer
En
cap
sula
tio
n
Fil
m C
oati
ng
Co
lum
n C
oati
ng
Wu
rste
r C
oati
ng
Bli
sters
Bo
ttle
s
Seri
ali
zati
on
Cart
on
ing
Lase
r P
rin
tin
g
Au
tom
ati
c V
isu
al
Insp
ecti
on
Manufacturing Packaging
Arecibo, PRII &
IIIx x x x x x x x x x x x x x x x
Aiken, SC x x x x xSingle
& Bi-
Layerx x x x x x x
Norman, OK x x x x xSingle
& Bi-
Layerx x x x x x x
Reims, FR x x x HAPA x
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Capabilities Matrix – Sterile F & F
Location Dis
pen
sin
g
Co
mp
ou
nd
ing
Sm
all
Vo
lum
e P
are
nte
ral
Ase
pti
c F
illi
ng
(V
ials
)
Sm
all
Vo
lum
e P
are
nte
ral
Ase
pti
c F
illi
ng
(A
mp
s)
Sm
all
Vo
lum
e P
are
nte
ral
TS
Fil
lin
g (
Via
ls)
Sm
all
Vo
lum
e P
are
nte
ral
TS
Fil
lin
g (
Am
ps)
Lyo
ph
iliz
ed
Pro
du
cts
Ase
pti
c P
ow
der
Fil
lin
g
Vis
ual
Insp
ecti
on
Ste
rile
Via
ls &
Am
po
ule
s
Seri
ali
zati
on
Cart
on
ing
Lase
r P
rin
tin
g
Lab
ell
ing
Manufacturing Packaging
Liscate, IT x x x x x x x x x x x x x x
avara.com | 14Company Confidential avara.com | 14
The Customer Relationship Team (CRT) is the team identified
and led by the Customer Relationship Leader (CRL) to deliver
projects on time and in full, as well as at the agreed upon cost.
This team manages the overall customer relationship.
The CRT is the key component for delivering on the Avara
pledge of providing a world-class, customer-oriented
outsourcing experience by delivering on our commitments:
scope, schedule, quality/regulatory compliance, and price
Avara and You—Customer Care-Customer Relationship Team
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Avara and You—Quality, Delivery, Integrity
We are Committed to delivering an exceptional
customer experience.
Our Company Culture allows us to deliver on
our assurances.
We offer Transparency in all operations and
communication.
We have the Flexibility to adjust to your
priorities and the agility to respond quickly.
We will work with Integrity in all areas so we can
earn your trust.
Avara is committed to being easy to work with.
When you partner with us, you can be assured
our priority is to deliver a world-class customer
experience.
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▪ We are grateful for your time and your consideration of this
presentation.
▪ We’d like to understand your needs and utilize Avara’s approach to exceed
your expectations with a world-class outsourcing experience.
Thank You!
Avara and You—Quality, Delivery, Integrity
Please visit www.avara.com for additional information.