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Corporate Presentation

Corporate Presentation Corporate Final... · 2020. 1. 27. · Company Confidential avara.com | 14 Avara and You— Quality, Delivery, Integrity We are Committed to delivering an exceptional

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  • Corporate 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

  • avara.com | 3Company ConfidentialCompany Confidential

    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: ~750

    ▪ Current SKUs: 250

    ▪ 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.

  • avara.com | 5Company ConfidentialCompany Confidential

    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

    MANUFACTURING & PACKAGING

    NORMANOKLAHOMA,USA► HQ

    ► ORAL SOLID DOSAGE

    MANUFACTURING & PACKAGING

    Avara Pharmaceutical Services

    Our Global Footprint

  • avara.com | 7Company ConfidentialCompany Confidential

    ▪ 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

  • avara.com | 8Company ConfidentialCompany Confidential

    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

  • avara.com | 9Company ConfidentialCompany Confidential

    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

  • avara.com | 10Company ConfidentialCompany Confidential

    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

  • avara.com | 11Company ConfidentialCompany Confidential

    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

  • avara.com | 12Company ConfidentialCompany Confidential

    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 | 13Company Confidential avara.com | 13

    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.com | 14Company ConfidentialCompany Confidential

    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.

  • avara.com | 15Company ConfidentialCompany Confidential

    ▪ 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/