Specialty Pharma

Specialty Pharma2018-07-11T21:26:50+00:00
Specialty Pharma

Halo Pharma is a leading global provider of drug product manufacturing services and drug delivery and formulation technologies for specialty pharma companies.

Halo Pharma has provided contract drug product development and manufacturing services for over 10 years. Halo has launched over 10 new products each year for the past three years.  Halo Pharma has significant technical transfer and regulatory expertise to support our Specialty Pharma clients who may acquire products but need a site to manufacture them.  While we excel at technical transfers, we also have successfully supported over 100 new product launches in the past 10 years.

Halo Pharma’s leadership team has over 200 years of combined experience in drug product manufacturing.

We partner with our clients to provide technical development solutions to address the increased pressure to meet pipeline timelines and budgets.

The drug candidates and commercial technical transfers include therapeutic treatments for:

  • Pain Management
  • Controlled Substances
  • Central Nervous System Disorders
  • Women’s Health
  • Dermatology
  • Rare Diseases
  • Gastrointestinal
  • Respiratory/Allergy
  • Men’s Health
  • Cardiovascular
  • Urology
  • Diabetes

We provide our clients flexible, quality led development and commercial solutions from rare diseases to larger patient populations and chronic diseases.

We specialize in:

  • Poorly Water- Soluble Drugs : Twin-Screw Extrusion (TSE) or Hot-Melt Extrusion (HME)
  • Pediatric: Mini and MicroTablets, Pellets, Beads, Powders, Capsules, Stick Pack, Liquid Suspensions
  • Dermatologic: Topical Non-Sterile Semi-Solid Ointments, Gels & Creams
  • Pain & Abuse Deterrent: Modified Release, Controlled Substances (CI-CV), , Fixed-Dose Combination (FDC)
  • CNS: Bi-Layer, Orodispersible, Granulation/Wurster (Solvent)
  • Ophthalmic/Wound Care: Sterile Ointments, Gels & Creams

We manufacture difficult-to-formulate drug products and provide bioavailability solutions to meet critical clinical endpoints

Halo Pharma partners benefit from a single Project Team providing continuity as products progress through the following stages that include:

  • Analytical Development, Transfer and Validation Activities
  • Drug Development and Formulation Technical Transfer
  • Manufacturing Non-GMP Laboratory Batches & Stability Programs
  • QbD Optimization Batches
  • cGMP Pilot Batches (Pharmacokinetics-Bio Batches)
  • cGMP Pivotal Batches (Bioequivalence Batches)

Many of our Partners in the specialty pharma sector rely on our “Brick and Mortar”.

Our integrated pharmaceutical development solutions are customized to focus on your program needs, which can include:

  • 505 (b) (2) pathway for oral modified specialty products
  • Orphan drugs for rare diseases
  • Technical Transfer of in-licensed late stage products
  • New indications or novel drug delivery formulation of exiting products
  • Product Line-Extensions (Pediatric dosage form for an Adult dosage form)