AVARA PHARMACEUTICAL SERVICES CORPORATE PRESENTATION Corporate Final... · 2019. 10. 31. ·...

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


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

avara.com | 4Company Confidential

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.


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.

avara.com | 6Company Confidential

LISCATEITALY►STERILE MANUFACTURING & DRUG PRODUCT PACKAGING

(LYOPHILIZED & SVP)

ARECIBOPUERTO RICO► ORAL SOLID DOSAGE

MANUFACTURING & PACKAGING

► CONTROLLED SUBSTANCES CII & CIII

AIKENSOUTH CAROLINA► ORAL SOLID DOSAGE


NORMANOKLAHOMA,USA► HQ

► ORAL SOLID DOSAGE


REIMSFRANCE►ORAL SOLID DOSAGE PACKAGING

►PRIMARY & SECONDARY DISTRIBUTION OF All

PHARMACEUTICAL DOSAGE FORMS

Avara Pharmaceutical Services

Our Global Footprint


▪ 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


Aiken, South Carolina

Facility Overview

▪ Acquired from GSK


▪ Multiple successful Rx to OTC switches

▪ Tablets, capsules, & lozenges

▪ Wet granulation, fluid bed granulation & drying

▪ Compression, coating, & printing

▪ Packaging into blister, bottle


Norman, Oklahoma

SHANNON, IRELANDFacility Overview

▪ Acquired from Astellas Pharma


▪ 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


Reims, France

Facility Overview

▪ Acquired from AstraZeneca


▪ 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


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


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


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


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.


▪ 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.

http://www.avara.com/

AVARA PHARMACEUTICAL SERVICES CORPORATE PRESENTATION Corporate Final... · 2019. 10. 31. ·...

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