A compelling approach to complexity

As a part of Pfizer and backed by its expert resources, our collaborative approach means we can explore more efficient routes to market and high-quality sterile injectables manufacturing.

You can count on us to do our best to carefully guide your compound from development through to commercial manufacture - we’ve been delivering on our promises for over 40 years.

Discover how we’re altogether different

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Collaborate with assurance

We’re part of Pfizer, so you’ll be supported by our team and backed by the tools, processes and experience of one of the world’s leading sterile injectables manufacturers.

With its own portfolio of biopharmaceuticals and injectables, Pfizer continually invests in our manufacturing sites to maintain them at the cutting edge of technology.

Our regulatory knowledge spans across the globe and we have established regulatory approvals in multiple markets including the U.S. FDA (United States), EMA (European Union), ANVISA (Brazil) and PMDA (Japan).

We have manufacturing capabilities in Biologics, Small molecules, Cytotoxics (liquid), and Lyophilization.

Let's collaborate

Lyophilization is challenging. We've been proudly doing it for more than 40 years

There are many complexities facing lyophilized product development and manufacturing. Using our extensive experience, we can optimize and scale-up your lyophilization process to match the needs of your unique compound at commercial scale.

By carefully considering your drug’s formulation, attributes and our lyophilization capabilities, our team of experts ensure proper cycle design every time.

Let's collaborate

Opening the doors to opportunity

Clinical Phases

  • Development & manufacturing
  • Technical transfer
  • Formulation optimization
  • Scale-up/validation

Submission

  • CMC preparation
  • Final package
  • Pre-approval inspection

Launch

  • Drug to market
  • Production efficiency studies

Lifecycle Management

  • Cold-chain management
  • Supply/distribution
  • Drug delivery expansion

Drug Substance

Sterile injectable manufacturing

  • Clinical 
  • Commercial 

 Manufacturing network includes: 

  • Australia (Melbourne)
  • China (Wuxi)
  • Croatia (Zagreb) 
  • Spain (Algete) 
  • United States (Kalamazoo, Michigan; McPherson, Kansas; Rocky Mount, North Carolina)

Services & processes

  • Aseptic fill-finish 
  • Terminal sterilization 
  • Lyophilization 
  • Combination products 

Compounds

  • Biologics 
  • Small molecules 
  • Controlled substances (II-IV) 
  • Liposomal 
  • Cytotoxics (liquid)
  • Vaccines (inactivated)
  • Monobactam 
  • Sterile suspensions 
  • Potent drugs 
  • Hormones, steroids & prostaglandins 
  • Diluents 

Global supply chain services

  • Serialization/track-and-trace programs 
  • On-site regulatory experts 
  • Gateway services, including quality release support and multi-lingual secondary packaging, labelling and package inserts 
  • Drug product storage and distribution: ambient (+15°C to +30°C), controlled room temperature (+15°C to +25°C), refrigerated (+2°C to +8°C), frozen (-15°C to -25°C) 

Container closure systems

  • Glass vials: 2mL – 100 mL 
  • Syringes (pre-filled syringes): 1mL – 5mL (tub configuration) 
  • Ampoules: 2mL – 10mL 
  • Cartridges

Secondary Packaging

  • Bulk (bright stock) 
  • Single-/multi-unit cartons 
  • Kitting