We manufacture, supply and distribute commercial formulations from our facilities in UK and India for Oral Solids and Lexington, USA for Sterile Injectables. We are a trusted manufacturing partner to leading biotech, small and virtual pharmaceutical companies as well as mid-size and big pharmaceutical companies. Our scalability is defined from Pilot level to Commercial level to serve customers at every stage of drug lifecycle from manufacturing perspective. We leverage our Global network of manufacturing sites and are successful in supplying commercial formulations to the US, Europe, Japan and Asia Pacific markets.

Speak to our
experts

Lyophilization

Manufacturing of lyophilized products centers around the 48 square foot Hull lyophilizer within the sterile manufacturing facility. We use a LyoStar™II and a LyoStar™3 R&D freeze dryer to develop lyophilized formulations that are based on robust and cost-efficient processes. We have rich experience in screening effective combinations of solvents (both aqueous and non-aqueous), buffers, bulking agents, and lyo/cryo-protectants. The technical expertise leads to delivery of a solid and attractive cake with low residual solvent that reconstitutes easily resisting the physical and chemical degradation.

Capabilities

  • Clinical scale the 48 square foot Hull lyophilizer
  • The lyophilizer chamber can accommodate up to 15,000 units per cycle depending on vial size
  • Hull Capabilities
    • Serum Vial Capacity (Number of Vials Processed)
    • Vial SizeApproximate Full Load
      3 mL15,000
      5 mL9,000
      10 mL7,500
      20 mL4,500
      30 mL3,200
      50 mL2,300

Facility Expansion

With Piramal’s ongoing commitment to sterile manufacturing, the Lexington, KY site is undergoing a phased facility expansion that includes increased capacity with the addition of isolator-based commercial-speed sterile filling lines and additional terminal sterilization capability. Our fill volume capabilities will now be extended till 100ml. In addition to two new fully integrated isolator-based filling lines, the site expansion encompasses two 25 square-meter lyophilization chambers with automated loading and unloading. Both filling lines and lyophilization chambers are designed to support potent and non-potent products as well as aqueous and non-aqueous formulations.

Key Additions:

  • Steriline Liquid Filling Line with Isolators
  • Bausch and Strobel Filling Line with Isolators
  • 2 Lyophilizers to be used in conjunction with the Bausch and Stroebel Filling line

LYOPHILIZATION Location

Aurora, Canada

This is our site for development and GMP manufacturing for complex pharmaceutical NCEs. It is located in Aurora, 50 kms north of Toronto.

See Our Facility

Lexington, USA

The Coldstream Laboratories manufacturing facility utilizes isolator technology for aseptic processing in a 22,000 square foot state‐of‐the art building.

See Our Facility

Riverview, USA

Our State-of the-Art FDA licensed cGMP facility in Riverview, USA, has over 50 years of extensive experience in delivering robust cGMP manufacturing processes..

See Our Facility

Grangemouth, UK

Grangemouth, UK is a USFDA and MHRA approved site dedicated to the contract development and manufacturing of Antibody Drug Conjugates since 2004.

See Our Facility

Morpeth, UK

The Pharma Solutions Morpeth site is one-of-a-kind US FDA and UK MHRA approved facility offering integrated services across the pharmaceutical value chain.

See Our Facility

Ahmedabad, India

Ahmedabad, India site was established in 2009. It is a MPA, Sweden approved and FDA approvable facility for development..

See Our Facility

Ahmedabad, India

Piramal Discovery Solutions site is located in Ahmedabad, India and provides a comprehensive range of early stage drug discovery services

See Our Facility

Mumbai, India

Operational since 2005, our Mumbai site is fully equipped for development of all liquid dosage forms both Sterile and Non-sterile.

See Our Facility

Pithampur, India

The Pithampur formulations site is a Greenfield project set in 1992 by Piramal Pharma Solutions. The US FDA and UK MHRA approved facility..

See Our Facility

Ennore, India

Ennore is identified as the India centre for development and early phase projects located near the Chennai port. The site is spread over an area of 75 acres..

See Our Facility

Digwal, India

It is a dedicated and multipurpose plant identified for custom manufacturing and development for late phase API’s and advanced intermediates.

See Our Facility

Mahad, India

It is a multipurpose plant identified for manufacturing of straight Vitamins & Vitamin Mineral Premixes.

See Our Facility

Aurora, Canada

This is our site for development and GMP manufacturing for complex pharmaceutical NCEs. It is located in Aurora, 50 kms north of Toronto.

See Our Facility

Lexington, USA

The Coldstream Laboratories manufacturing facility utilizes isolator technology for aseptic processing in a 22,000 square foot state‐of‐the art building.

See Our Facility

SHANGHAI, CHINA

See Our Facility

OUR LOCATIONS

With a versatile, fully integrated network of development and manufacturing sites across North America, Europe, and Asia. Learn more about how we can serve your needs locally, wherever you are

Great!