quality delivery integrity capabilities.pdf+ primary & secondary packaging + distribution norman...

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AIKEN SOUTH CAROLINA, USA + Former GSK Facility + OSD Manufacturing & Packaging ARECIBO PUERTO RICO + Former Merck Facility + OSD Manufacturing & Packaging LISCATE ITALY + Former Pfizer Facility + Sterile Fill-Finish Drug Product Manufacturing & Packaging REIMS FRANCE + Former AstraZeneca Facility + Primary & Secondary Packaging + Distribution NORMAN OKLAHOMA, USA + Former Astellas (Prev. Yamanouchi) Facility + OSD Manufacturing & Packaging INTEGRITY DELIVERY QUALITY We will deliver on our commitments… … on time; in full. Across every project and relationship, we are wholly focused on delivering to scope, schedule and budget, while exceeding quality and regulatory standards. … leveraging longstanding expertise. Avara is led by a team of experienced, entrepreneurial executives with proven backgrounds in pharmaceutical manufacturing, healthcare and technical services. … by putting people first. We have fostered a uniquely long-tenured staff, which translates to tremendous institutional knowledge and continuity for our customers. …from global, commercially-proven facilities. We have built our global site footprint by acquiring facilities from leading pharmaceutical companies with demonstrated commercial track records. …with transparency and flexibility. Our customer relationships are built on open, honest communication and transparency into our processes. We will always tailor our approach to align with your needs. COMMITTED TO EXCELLENCE Avara offers development, manufacturing and packaging services for pharmaceutical drug product at both clinical and commercial scale. Our approach is one of quality, delivery and integrity—we are relentlessly focused on our customers’ success, which we achieve through a set of guiding principles designed to ensure an exceptional experience across every project. THE AVARA PROMISE Avara is a full-service CMO committed to delivering a world-class outsourcing experience to our global customers.

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Page 1: QUALITY DELIVERY INTEGRITY Capabilities.pdf+ Primary & Secondary Packaging + Distribution NORMAN OKLAHOMA, USA + Former Astellas (Prev. Yamanouchi) Facility + OSD Manufacturing & Packaging

AIKENSOUTH CAROLINA, USA

+ Former GSK Facility + OSD Manufacturing & Packaging

ARECIBOPUERTO RICO

+ Former Merck Facility + OSD Manufacturing & Packaging

LISCATEITALY

+ Former Pfizer Facility + Sterile Fill-Finish Drug Product Manufacturing & Packaging

REIMSFRANCE

+ Former AstraZeneca Facility + Primary & Secondary Packaging + Distribution

NORMANOKLAHOMA, USA

+ Former Astellas (Prev. Yamanouchi) Facility + OSD Manufacturing & Packaging

INTEGRITY

DELIVERY

QUALIT Y

We will deliver on our commitments…

… on time; in full. Across every project and relationship, we are wholly focused on delivering to scope, schedule and budget, while exceeding quality and regulatory standards.

… leveraging longstanding expertise. Avara is led by a team of experienced, entrepreneurial executives with proven backgrounds in pharmaceutical manufacturing, healthcare and technical services.

… by putting people first. We have fostered a uniquely long-tenured staff, which translates to tremendous institutional knowledge and continuity for our customers.

…from global, commercially-proven facilities. We have built our global site footprint by acquiring facilities from leading pharmaceutical companies with demonstrated commercial track records.

…with transparency and flexibility. Our customer relationships are built on open, honest communication and transparency into our processes. We will always tailor our approach to align with your needs.

COMMITTED TO EXCELLENCEAvara offers development, manufacturing and packaging services for pharmaceutical drug product at both clinical and commercial scale. Our approach is one of quality, delivery and integrity—we are relentlessly focused on our customers’ success, which we achieve through a set of guiding principles designed to ensure an exceptional experience across every project.

THE AVARA PROMISE

Avara is a full-service CMO committed to delivering a world-class outsourcing experience to our global customers.

Page 2: QUALITY DELIVERY INTEGRITY Capabilities.pdf+ Primary & Secondary Packaging + Distribution NORMAN OKLAHOMA, USA + Former Astellas (Prev. Yamanouchi) Facility + OSD Manufacturing & Packaging

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AVARA CORPORATE HEADQUARTERSAvara Pharmaceutical Services, 3300 Marshall Avenue, Norman, OK 73072 Tel: +1 405 217 7670 Email: [email protected] www.avara.com

ARECIBOPUERTO RICO

AIKENSC, USA

NORMANOK, USA

REIMSFRANCE

LISCATEITALY

Controlled Substances II & III

Milling ● ● ●

Blending ● ● ●

Dry Granulation ● ● ●

Wet Granulation ● ● ●

Drying ● ● ●

Compression Single, Bi-& Tri-Layer ●Single & Bi-Layer

Single & Bi-Layer

Encapsulation ● ●

Film Coating ● ● ●

Column Coating ●

Wurster Coating ●

Dispensing ●

Compounding ●

Small Volume Parenteral Aseptic Filling (Vials)

Small Volume Parenteral Aseptic Filling (Ampouls)

Small Volume Parenteral TS Filling (Vials) ●

Small Volume Parenteral TS Filling (Ampouls)

Lyophilized Products ●

Aseptic Spray Drying ●

Aseptic Powder Filling ●

Visual Inspection ●

Blisters ● ● ● ●

Bottles ● ● ●

Sterile Vials & Ampoules ●

Serialization ● ● ● ●

Cartoning ● ● ● ● ●

Laser Printing ● ● ● HAPA ●

Automatic Visual Inspection ● ● ● ●

Labelling ●

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FPA

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AG

ING

CAPABILITIES

PLANT CAPABILITY MATRIX