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GMP Contract Manufacturing

Gmp Contract Manufacturing

Piramal Pharma Solutions offer expertise in GMP manufacturing of materials to support Phase I to Phase III clinical trials, as well as product registration. We always work with the goal of developing a formulation and the relevant processes that are needed for successful scale-up and large-scale manufacturing on automated equipment. Our manufacturing sites have been successfully inspected by numerous regulatory agencies including the US FDA and EU EMA

Product Capabilities

  • Comprehensive range of solid dosage forms
  • Liquid and Lyophilized Parenterals
  • Control Drug Substances
  • Potent compounds such as Hormones, Oral Contraceptive Pills (OCPs) and Cytostatic compounds

Salient Features of GMP Manufacturing

  • GMP manufacturing
  • In additional to Human Clinical Products, Pre-Clinical to Commercial supplies of Sterile Injectables in the Veterinary segment
  • Quality by Design process development
  • Manufacturing, packaging and release testing
  • Chemistry, Manufacturing and Controls (CMC) documentation for your IND or NDA
  • Manufacturing of drug product and matching placebos
  • Over-encapsulation of tablets or capsules
  • Product blinding
  • Sourcing of Comparator drugs or con meds
  • Proprietary web based tool, TrakPack, to track clinical kit status
  • Adherence to U.S., EU, Japanese and other market standards

Locations

  • Morpeth, UK
  • Coldstream, Kentucky, USA
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