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FIRST ENTRY GENERICS | RARE MOLECULES

Recent years have seen exciting breakthroughs in biomedical sciences that are producing truly novel therapeutics for unmet patient needs. A paradigm shift in the operating business models of pharmaceutical companies is witnessed by the transition to a lean, focused company with a research footprint within key innovation bioclusters and a growing revenue stream from specialty products and biologics and, emerging markets.

With novel drug targets becoming more competitive, order of entry has become an increasingly important consideration for clinical-development decisions and commercial resourcing. First-mover advantage is more pronounced in specialty areas with small numbers of prescribers and patients and Injectable drugs have stronger first-mover effects than oral preparations.

In the midst of these exciting times for the pharmaceutical industry, you will find a resourceful partner in Xeina Drugs, that constantly endeavours to bring to you novel drugs to add to your portfolio and gain a first entry advantage.

Why license Specialised Products from Xeina Drugs
  • Novel drugs portfolio, first entry generics
  • EU approved facilities and EU CTD dossiers
  • Bioequivalence studies for oral formulations
  • Open for FDF supply

SPECIALIZED PORTFOLIO

LIPOSOMAL AMPHOTERICIN B

  • Full EU CTD dossier available
  • USFDA facility approval expected in Q2 2020
  • Open for tech transfer, FDF supply, API supply

LIPOSOMAL DOXORUBICIN

  • Full EU CTD dossier available
  • USFDA facility approval expected in Q2 2020
  • Open for tech transfer, FDF supply, API supply

LEUPROLIDE DEPOT INJECTION

  • Full EU CTD dossier available
  • USFDA facility approval expected in Q2 2020
  • Open for tech transfer, FDF supply, API supply

OCTREITIDE LAR INJECTION

  • Full EU CTD dossier available
  • USFDA facility approval expected in Q2 2020
  • Open for tech transfer, FDF supply, API supply

ALBUMIN BOUND NANOPARTICLE PACLITAXEL

  • Full EU CTD dossier available
  • USFDA facility approval expected in Q2 2020
  • Open for tech transfer, FDF supply, API supply

DYDROGESTRONE

  • First generic in the world
  • Manufactured at an EU approved facility
  • Full EU CTD dossier to be available by Q1 2019
  • Open for FDF supply only

APOMORPHINE

  • Indicated in last stage of Parkinson’s, apomorphine is not a controlled drug substance
  • Amongst the first few generics in the world
  • Manufactured at an EU approved facility with full EU CTD dossier available
  • Available as a vial, ampoule and an innovative pen injector and innovative pump
  • Open for FDF supply only

TRIENTINE HCL

  • Indicated in Wilson's disease
  • Amongst the early generics in the world manufactured at an EU approved facility
  • Full EU CTD dossier to be available
  • Open for FDF supply only

ILOPROST

  • Indicated in pulmonary hypertension
  • Amongst the early generics in the world manufactured at an EU approved facility
  • Product available with inhalation device
  • Full EU CTD dossier available
  • Open for FDF supply only

PLERIXAFOR

  • Indicated as a hematopoietic stem cell mobilizer
  • Amongst the early generics in the world manufactured at an EU approved facility
  • Full EU CTD dossier available
  • Open for FDF supply only

* Patent evaluation in respective countries to be done by the clients

RELATED LINKS - XEINA DRUGS PRODUCT PORTFOLIO:
Finished Dosage Formulations  |  Biosimilars  |  Specialized Products  |  Facial Aesthetics