Arecibo, Puerto Rico

Secondary Manufacturing & Packaging

The Arecibo facility in Puerto Rico was acquired from Merck, and offers manufacturing and packaging capabilities for oral solid dose drug product, including high containment.

The facility has been operating for over 35 years and has a track record as a compliant and reliable source of supply for multiple blockbuster products.


Capabilities

  • Secondary Manufacturing
    - Granulation - high shear / fluid bed
    - Coating - fluid bed / film coating
    - Blending - double cone ribbon
    - Encapsulation - pellet and powder
    - Compression - direct, double sided
    - Drying - tray / continuous feed

  • Formulation Experience
    – Immediate release
    – Controlled release

  • Packaging
    – Blisters / Bi-fold
    – Trade bottles (high speed lines)
    – Laser printing capability
    – Automatic inspection systems
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Avlon, United Kingdom

Primary Manufacturing

The Avlon facility in the United Kingdom was acquired from AstraZeneca. The site has developed and manufactured APIs since 1970, and is a Worldwide Pharmaceutical Services Center of Excellence for Avara. It manufactures multiple intermediates and APIs, including rosuvastatin (Crestor®) and quetiapine (Seroquel®) for AstraZeneca.

The site comprises seven manufacturing facilities, plus a cGMP large-scale laboratory. There are custom-built areas for synthesis, purification, drying, milling and storage. It also has a large cGMP warehouse with cold chain capability (2-8ºC), plus a dedicated biological wastewater treatment facility.


Capabilities

  • Five Large-Scale cGMP API Plants
    – Large volume commercial manufacture of intermediates and APIs
    – 1.6m3 to 10m3 reactor capacity
    – Pressure filter, conical and centrifuge drying
    – High hazard chemistry
    – Synthesis
    – Purification
    – Storage

  • Two Large-Scale Milling Facilities
    – Two Hosakawa mills, 315 UPZ and associated equipment
    – Matcon bin charging

  • cGMP Large-Scale Laboratory
    – 10 L to 100 L reactor capacity
    – Chlorination with POCl3
    – Oxidation with peroxide and hypochlorite
    – Grignard reagents
    – Metal catalysts
    – Formulation
    – Cryogenic reactions

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Norman, Oklahoma

Secondary Manufacturing & Packaging

The Norman facility in Oklahoma, USA was acquired from Astellas. It has been manufacturing for over 35 years and has provided contract manufacturing of oral solid dosage forms for more than 25 years. The site has the capability to manufacture over two billion tablets a year. It has an experienced, knowledgeable, dedicated and diverse team.

Over 300,000 square feet of building space serves dosage form development, commercial manufacturing, formulation, analytical laboratories, and warehousing.


Capabilities

  • Clinical-Scale Drug Product
    – Milling
    – Spray drying
    – Fluid bed granulation
    – Blending
    – Compression
    – Coating
    – CTM packaging
    – CTM storage, including returned material

  • Commercial-Scale Drug Product
    – Milling
    – Spray drying
    – High shear granulation
    – Roller compaction granulation
    – Fluid bed granulation
    – Blending
    – Compression
    – Coating
    – Tablet printing
    – Commercial-scale packaging

  • Development Support
    – Process development / optimization
    – Analytical methods development
    – Transfer methods
    – Product release testing
    – Stability storage and testing

  • Packaging
    – Bottles
    – Blisters
    – Serialization (international requirements)
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Norwalk, Connecticut

Global Headquarters

Avara Pharmaceutical Services’ global headquarters is located approximately 50 miles northeast of New York City.

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Shannon, Ireland

PRIMARY MANUFACTURING

The Shannon facility in Ireland was acquired from UCB. It has been in operation for over 40 years.

Avara Shannon has manufactured API under contract for five of the top ten global pharmaceutical companies. It has a strong track record in process validation and tech transfer, a history of successful GMP inspections by the FDA and HPRA, and an equally robust EH&S record.


CAPABILITIES

  • API Manufacturing

  • cGMP Kilo Plant
    – 60 L to 75 L reactor capacity
    – Centrifuge & filter isolation
    – Process scale-up & optimization
    – Multi-purpose flexibility
    – Hazardous material capability

  • Two Large-Scale cGMP API Plants
    – 1m3 to 8m3 reactor capacity, total capacity >100m3
    – Alkylation, nitration, Grignard, hydride reduction & hydrogenation
    – Hazardous & complex chemistry
    – Multi-purpose / multi-product design

  • cGMP Drug Product Plant
    – Milling & blending
    – Analytical Services

  • Process Development & Support

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