We are a reliable and an experienced supplier of special formulations, offering development and manufacturing services. We have a team with years of experience in the industry. We have developed expertise in a few niche areas to provide value addition to our customers like. Our specialized services helps your project to surface at a higher level from an innovation perspective. We have a capability for the development of various dosage forms that offers flexibility in formulation development. We have distinct capabilities of handling high potent compounds especially in the area of hormones and oncology that helps us to become a preferred partner of choice!

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Piramal facilities have the scientific capability and expertise to develop pediatric formulations meeting the age appropriate and regulatory requirements. We also offer clinical research capabilities to conduct pediatric formulation screening studies to support scientific screening of various formulations during thedevelopment and selection stage.

Formulation Development Capabilities

  • Oral Liquids (solutions/suspensions)
  • Chewable Tablets
  • Mouth Dissolving (Dispersible) Tablets
  • Powder for reconstitution
  • Effervescent powders/tablets
  • Age appropriate Tablets and capsules

Salient Features

  • NCE mindset of scientific understanding of kinetics and stability
  • Regulatory understanding of global requirements
  • Track record of aggressive learning to create competitive edge
  • Ability to understand the product + package value
  • Taste Masking technologies
Formulation Approach
  • Sensory Optimization
  • Compatible excipients
  • Solubility reduction
  • Particle size
  • Dose Volume
Taste masking technologies
  • Particle coating
  • Ion Exchange
  • Special Excipients
  • Salt form
  • Complexation
  • Encapsulation
Drug delivery technologies
  • Fast melt
  • Controlled release
  • Modified release
  • Packaging Solutions

We are a reliable, experienced, low risk supplier of hormonal based solid dose formulations with 40+ years of experience in offering development, manufacturing and packaging services from dedicated and segregated suites at out Morpeth, UK site.

Our Capabilities

Your 'One-stop shop' for Hormonal Products

Development Capability

  • Experienced formulation and analytical development team
  • Wide range of development and analytical equipment
  • Experience in supporting tech transfer, ANDA generation & clinical development batches

Infrastructure

  • Dedicated manufacturing sites
  • Dedicated packaging booths
  • All air handling units single pass with terminal HEPA filtration

Commercial Supply

  • Dedicated manufacturing and packaging suites
  • 40 years experience supplying hormonal based products
  • An outstanding regulatory track record

Launch Capability

  • A wealth of experience supporting global product launches
  • A wealth of experience managing complex supply chains end to end

Salient Features

  • More than 40 years experience with hormonal based products
  • Site accredited with MHRA and FDA approvals
  • Extensive capability to package multi-phasic products
    • Oral Contraceptives Pills
    • Hormone Replacement Therapies, Gynaecological oral therapies
    • Oncology hormonal based products &
    • Miscellaneous compounds with actions related to sex hormones

Nano formulations

  • Alter pharmacokinetics and bio-distribution of drug
  • Facilitate targeted delivery of drugs
  • Sustained local therapeutic drug levels
  • Reduced toxicity, side-effects
  • Enhance stability: Peptides
  • Enhance solubility of poorly soluble agents

Liposomes

  • Serve as a solubilization matrix for poorly soluble agents
  • Act as a pulmonary sustained release reservoir
  • Facilitate intracellular delivery of drugs
  • Prevent local irritation of lung tissue and reduce pulmonary toxicity
  • Prolong local therapeutic drug levels
  • Generate high intracellular drug concentrations

PEGylated formulations

  • Increases solubility of drug in aqueous media
  • Increases half-life of the drug, thus reducing the dosage frequency
  • Stabilizes and improves the therapeutic activity of the drug
  • Reduces toxic side effects, and increases quality of life due to controlled release

Co-Crystals

  • Opportunity to modify properties of drug
  • To crystallize difficult API's
  • Alternative to salt form (useful for non-ionizable API's)

Paediatric Formulations 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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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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