Drug Product Manufacturing

Drug Product Manufacturing
Product Description

BioDuro-Sundia's Drug Product manufacturing services support clinical and commercial scale GMP production for a comprehensive range of oral solid dosage forms, including: solid, liquid, and semi solid dosage forms. This includes fully-audited manufacturing facilities (FDA and other regulators) with exceptional track records.  Our manufacturing teams work closely with our formulation development teams to ensure optimal drug delivery from all dosage forms, especially poor solubility APIs.
Dosage forms

Tablets 

  • Intermediate Table Release
  • Coated Tablets
  • Matrix Tablets
Capsules
  • Blend in capsules
  • Tablets in capsules
  • Liquid in capsels
  • API in capsules
  • Pellets in capsules
Topicals
  • Intermediate Table Release
  • Coated Tablets
  • Matrix Tablets
Ophthalmic

Beads, Pellets, & Granules
  • Coated pellets/beads
  • Controlled release beads
Oral Liquids
  • Solutions
  • Suspensions
Injectables Solutions

Packaging
  • Tablets in bottles
  • Capsules in bottles
  • Liquid in bottles/vials
Formulation Technologies
  • Amorphous Solid Dispersions: Spray-drying; Hot-melt extrusion
  • Tablet Compression
  • Encapsulation
  • Milling
  • Wet granulation
  • Blending
  • Roller Compaction
  • Freund-Vector LDCS Pilot Hi-Coater
  • Fluid-bed drying
  • Dry granulation
  • Early Phase GMP Form Kilo Lab (outsource)

BioDuro-Sundia

  • US
  • 2018
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Contract Service

BioDuro-Sundia

  • US
  • 2018
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Contract Service

More Products from BioDuro-Sundia (4)

  • Drug Substance

    Product Drug Substance

    BioDuro-Sundia’s Drug Substance manufacturing services support production of small molecule APIs, RSMs and intermediates--both GMP and non-GMP .  We provide a full range of production scale, supporting all stages of drug substance development through IND submission.  Fully integrated CMC ser...
  • Process Development

    Product Process Development

    BioDuro-Sundia’s process development services support drug substance production,  providing an efficient path to manufacture API or intermediates. Our extensive services support production of API for GLP toxicology studies, IND-enabling studies, clinical studies, and commercialization efforts. qq...
  • Formulation Development

    Product Formulation Development

    BioDuro-Sundia holds more than 25 years of experience formulating poor solubility and  poor permeability drugs for the clinical studies. Our comprehensive suite of advanced formulation technologies and extensive scientific know-how supports >95% of marketed dosage form...
  • Analytical Development

    Product Analytical Development

    BioDuro-Sundia’s Analytical Testing team offers high quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, and CMC dossier preparation services. ...

BioDuro-Sundia resources (1)