Oncology Development and Manufacturing

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We have dedicated unit for High Potent compounds including cytotoxic (oncology) and hormones facilitated with isolators and protective suits. with the highest level of work safety and regulatory compliance. We have successfully delivered multiple formulation development programs for generic as well as first to file oncology products.

Our expertise include:

Formulation Development

Enaltec Highly Potent & Oncology platform utilizes state-of-the-art high containment technology and processes for Drug Products and generic formulation development of HPAPI’s up to OEL 4

  • Pre-formulation

  • Drug –Excipient compatibility study

  • Formulation Development

  • Process development and optimization using QbD/ DoE approach

  • Tech-Transfer to client/ CMO site

Pilot Scale Manufacturing

Our newly commissioned HPAPI GMP facility can undertake non-sterile development and manufacturing of Highly Potent API’s up to OEB4 for solid dosage forms (tablets, capsules/batches up to 5Kg). We can supply following through our facility:

  • Pilot BE batches

  • GMP supplies for Oncology products

Analytical Services

Dedicated analytical unit for-

  • Analytical Method Development and Validation to monitor Starting Materials, In Process and Final Release testing

  • Forced Degradation (Stress) Studies

  • Stability Studies to ICH requirement

  • Cleaning validations

  • Qualification of Reference and Impurity Standards