Piramal Pharma Solutions now offers High Potency API (HPAPI) services following its acquisition of Ash Stevens, a global leader with over five decades of experience in HPAPI development and cGMP manufacture. Our FDA approved cGMP facility located in Riverview, MI (USA) offers a full range of scale and containment options for HPAPIs.

HPAPI manufacturing is a complex process and our track record of successful launches ,state-of-the-art facility, robust engineering controls and a stellar safety record make us a preferred 'Partner of Choice' for high potency projects.

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Services Offered

  • Development and Manufacture of HPAPIs
    • Process Research, Development, Optimization and Scale-Up
    • cGMP Manufacturing for Clinical Trials
    • Commercial Manufacturing
  • Comprehensive Analytical and Regulatory Services to Support Early-Stage Development through Registration and Commercial Manufacturing
  • Impurity Identification, Characterization, and Synthesis
  • Solid State Characterization (XRPD, DSC, TGA and PSD)
  • Quality by Design (QbD) Services Consistent with ICH Guidelines
  • Reference Standard Qualification and Stability Studies
  • Safety/Hazard Assessments
  • Process Safety Team – Project and Scale-up Safety Assessments
  • Hazard Assessment Laboratory Instrumentation: RC-1, DSC, TSU, ARC
  • Documentation for Regulatory Submissions (IND, NDA, DMF, CTD)

Site Capabilities

  • Comprehensive API Development and Manufacturing Capabilities from Gram Scale to Hundreds of Kilos
  • Up to 4,000 L Glass Lined Reaction Vessels with a Temperature Range of -70°C to 200°C
  • Product Isolation Capabilities: Extraction, Filtration, Centrifugation, Distillation
  • Drying/Finishing Facility : Rosenmund Filter Dryers, Forced Air & Vacuum Drying Ovens, Class 10,000 Clean Suites
  • State-of-the-Art High Potency API Manufacturing Suite with Airlocks and Barrier Isolation System
  • Scaled Rosenmund Filter Dryer Capacity with Glovebox Technology to Facilitate Contained Isolations from Laboratory to Plant Scale
  • Reactor Bays Equipped with Necessary Engineering and Process Controls to Safely Handle HPAPIs at Large Scale

Safety & Environmental Responsibility

The health and safety of our staff, visitors and community are the primary considerations in the operation of our business. Riverview has an excellent chemical hygiene program in place that closely monitors air quality and other environmental data in our facilities to ensure a safe operating environment. Hazard identification and risk assessments are also an integral part of project management and planning.

Why choose us?

  • 14 US FDA Manufacturing Approvals (NCEs)
  • Significant experience in Fast Track Approvals and orphan diseases
  • Successful Global Regulatory Inspection History :US FDA,EMA & UK MHRA,Health Canada ,PMDA Japan, MFDS Korea, TGA Australia & COFEPRIS Mexico among others
  • Recognised as a Global top 10 % CMO
    • Multiple CMO Leadership Awards, Recognized in All Five Categories plus All Eight Individual Attribute Categories (2010 – 2017)
    • Leader in SOCMA's ChemStewards® Program for Continuous Improvement in EHS&S Operations
  • Longstanding provider of contract research services to the National Institutes of Health (NIH) and the National Cancer Institute (NCI)

Locations

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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Other Offerings

API Manufacturing

High Potency APIs (HPAPIs)

Finished Dosage Manufacturing

Late Lifecycle Management

We consider route scouting as a focused business to rapidly assist our partners in discovering and developing cost effective, competitively advantaged, robust chemical processes from early drug phase through commercial launch.

We provide our enzyme catalyzed processes for fast track discovery and development of novel, green & economical routes to APIs.

We have been providing pharmaceutical intermediate and API process development services for nearly three decades from our network of R&D and manufacturing facilities across the globe.

With very small quantities of active pharmaceutical ingredients (API) or drug-able candidate molecules, Piramal Pharma Solution's pre-formulation service can provide valuable information and expertise to guide the compounds to next steps.

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