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.

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Form Fill Seal

We offer Form Fill Seal (FFS) service from our Pithampur, India facility. We have an experience in handling Eye/Ear drops and contact lens cleaning solution for unit/multi dose vials. The Pithampur site is well equipped with Weiler filling machines for accurate filling. One of these machines is specialized with unique Isolation Insertion Technology offering Blow Fill Seal (BFS). Our facility is available for non-regulated and medical devices.

Process Capability

  • Eye / Ear Drops
    • Batch Size :- 100 Lit – 600 Lit.
    • Fill volume :- 0.35ml, 5 ml,10 ml.
    • Dosage :- Aqueous Solution ∓ Steroids/Suspension.
    • Product Sterilization :- By Filtration
    • Resin Handled :- LDPE
  • Contact Lens Care Products
    • Batch Size :- 5000Lit. –10,000Lit.
    • Dosage :- Aqueous Solution
    • Fill volume :- 15ml.
    • Product Sterilization :- By Filtration
    • Resin Handled :- LDPE

Accreditations

  • WHO GMP 1993
  • SA MCC 2001, 2005
  • INVIMA (Columbia) 2004
  • ISO-9001: (Certified since 1996) 2000 ,2002
  • ISO-14001 2003 (Certified since 1999)
  • ISO 13485 2004
  • ISO 13485 2004

FORM FILL SEAL 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.

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Lexington, USA

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

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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..

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Grangemouth, UK

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

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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.

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Ahmedabad, India

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

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Ahmedabad, India

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

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Mumbai, India

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

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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..

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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..

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Digwal, India

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

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Mahad, India

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

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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.

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Lexington, USA

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

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SHANGHAI, CHINA

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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

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