We offer Pharmaceutical Development Services for various dosage forms such as Oral solids, Sterile Injectables and Non Sterile Liquids from our facilities in US, UK an India. As a leader in integrated solutions, we seamlessly engage our global sites to conduct development work in parallel; accelerating time to market and reduce costs for our customers.

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API Properties

  • Chemical: Solubility (equilibrium / kinetic), hygroscopicity, thermal behaviour, log P, stability.
  • Physical: Microscopy, particle size

Pre-formulation

  • Solubility
  • Forced degradation
  • Particle size
  • Excipient Compatibility
  • Fast content uniformity

Formulation

  • Analytical Methods Development / Validation / Transfer
  • Clinical Supply Release
  • ICH Stability studies
  • Identification of unknown impurities
  • Cleaning validations

    ORAL SOLIDSSTERILE INJECTABLES
    Comparator Testing: Fixed Dose Combination, Modified Release formulationsExtractable and leachable studies
    Blend UniformityForced degradation studies
    Hardness / Friability / Bulk DensityMoisture content
    DisintegrationResidual solvent determination
    Moisture (KF and LOD)Cleaning validation
    Particle size distribution (granules)Raw material, in-process, and finished product testing
    Sieve fraction analysisDissolution testing (immediate and extended release)
  • Stability Studies
    • In order to ensure the safety and efficacy of your drug product, Piramal currently offers stability programs with chambers covering -20°C, 2-8°C, 25°C/60%RH, and 40°C/75%RH, as well as an R&D photostability chamber. Our wide variety of testing services, according to the International Conference on Harmonization (ICH) guidelines, will equip you with the data that you need for your filing.
  • Analysis to Support Formulation Development
    • Excipient Compatibility
    • Fast content uniformity
    • Bio-relevant Dissolution for formulation selection
    • Discriminatory dissolution method development based on solubility, pKa, ionization state, and excipients

Analytical (Microbiology)

  • Environment Monitoring of Classified Areas.
  • Microbiological analysis of Water. (Testing the quality of water)
  • Microbial Enumeration Test (Total number of microorganism present in product).
  • Stability Studies along with Preservative Efficacy testing.
  • All testing as GLP requirements.

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

Route Scouting

Biocatalysis

Process R&D Services

Pre- Formulation Studies

Pharmaceutical Development

Analytical Support Services

Regulatory Services

Clinical Trials Services

Specialized Services

Piramal Discovery Solutions (PDS) is a reputed service provider for mg to gm scale discovery chemistry. We have partnered with a range of well known pharmaceutical and biotechnology companies from Europe, USA and Japan.

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

Our capabilities harness the superior stereoselectivity, chemoselectivity and regioselectivity of Nature’s catalysts for the synthesis of complex molecules.

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. Our synergistic model of delivery across Canada, India and the UK offers the advantages of speedy drug development, proximity to markets, as well as flexible solutions. We have a team of over a hundred scientists across geographies supported by an infrastructure of fume-hoods, kilo labs, analytical instrumentation and GMP, as well as non-GMP production areas.

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. Our pre-formulation team has extensive experience handling a wide range of compounds and can suggest the path forward for early success.

We offer Pharmaceutical Development Services for various dosage forms like Oral solids, Semi-Solids and Liquids (Sterile and Non-Sterile) from our facilities across UK and India. Being an integrated global solution provider we have the flexibility to simultaneously engage our facilities for conducting parallel development work to reduce the go-to-market time and costs for our customers

We offer a full range of analytical services, including analytical method development, validation and transfer, stability studies, comparator and in-process testing, from our state-of-the-art facilities and experienced scientific staff.

Piramal Corporate Regulatory Affairs, located in Mumbai, India provides expert clinical & regulatory support in all phases of global drug development programs. This includes regulatory support of New Chemical Entity’s development (NCE), Clinical Trials, Marketing products, Generics, OTC products & Medical devices

We offer specialized services in the area of Clinical Trial Supply management using our global network of assets, our experience and expertise in streamlining the clinical trial packaging and supply process, thus ensuring that the study drug is available where you need it and when you need it. Our advanced software, ‘Trak Pack®’, tracks the movement of the batch supplies across the supply chain.

Piramal facilities have the scientific capability and expertise to develop paediatric formulations meeting the age appropriate and regulatory requirements. We also offer Clinical Research Capabilities (CRO) to conduct Paediatric formulation screening studies to support scientific screening of various formulations during the development and selection stage.

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