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)

Read more Show less

BioDuro

  • US
  • 2018
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Contract Service
View company profile
Categories
more categories Show less
Sales Markets
Show more Show less

BioDuro

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

More Products from BioDuro (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 resources (13)

  • Company Video - Integrated Drug Discovery, Development and Manufacturing at BioDuro-Sundia

    Video Company Video - Integrated Drug Discovery, Development and Manufacturing at BioDuro-Sundia

    BioDuro-Sundia is your partner for accelerating drug discovery, development and manufacturing--from molecule to market. Find out more at http://www.bioduro-sundia.com. 
    2023-02-17
  • Drug Product - Development & Manufacturing

    Brochure Drug Product - Development & Manufacturing

    BioDuro-Sundia provides clinical development and commercial manufacturing of drug product—specializing in oral solid dosage forms and poorly soluble APIs. Our drug product services platform combines comprehensive pre-formulation assessment with advanced formulation technologies and robust GMP manufacturing capability.
  • Drug Substance - Development & Manufacturing

    Brochure Drug Substance - Development & Manufacturing

    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.
  • Drug Substance - Process Development

    Brochure Drug Substance - 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.  
  • Formulation - Solution Engine 2.0

    Brochure Formulation - Solution Engine 2.0

    BioDuro-Sundia’s Solubility Enhancement service is the fastest & most effective path to clinical formulation. We combine computer modeling, in-vitro screening & in-vivo PK to deliver optimal Amorphous Solid Dispersion prototypes. With 50-100mg of API & 8-10 weeks, we provide reliable prototypes to use in Phase I formulation & dosage development.
  • Analytical Development

    Brochure Analytical Development

    BioDuro’s analytical team is well-integrated into the formulation and manufacturing programs to facilitate and accelerate the development of the analytical methods and testing of prototypes, raw materials and drug products. Sharing knowledge of the formulation and the manufacturing process results in analytical data that is scientifically sound and project support that is well-coordinated and timely.

    Experienced and dedicated development and QC chemists at BioDuro are committed to the highest levels of technical quality and GMP compliance.
  • Drug Product - Commercial Capability

    Brochure Drug Product - Commercial Capability

    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.
  • Drug Product - Clinical Capability

    Brochure Drug Product - Clinical Capability

    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 forms.  Our GMP manufacturing operations focus on quality, efficiency and reliability ensures timeliness for your clinical trial supply. 
  • Drug Product - Amorphous Dispersions

    Brochure Drug Product - Amorphous Dispersions

    Bioavailability enhancement for poorly soluble compounds
  • Drug Discovery - Chemistry

    Brochure Drug Discovery - Chemistry

    BioDuro-Sundia offers Discovery Chemistry services provide small molecule design and synthesis to guide your drug discovery program through hit generation, SAR, lead optimization and candidate selection. We leverage decades of cutting edge expertise in medicinal, synthetic, and computational chemistry.
  • Drug Discovery - Biology

    Brochure Drug Discovery - Biology

    BioDuro-Sundia’s Discovery Biology team has extensive experience in assay development and compound screening using biochemical and cell-based phenotypic functional assays for all major classes of drug targets, including: enzymes, GPCRs, epigenetics, PROTACs and beyond.
  • Drug Discovery - DMPK

    Brochure Drug Discovery - DMPK

    BioDuro-Sundia's Drug Metabolism and Pharmacokinetic (DMPK) services provide high quality in vitro and in vivo studies to help predict therapeutic outcomes and advance programs toward the clinic. We integrate with our early formulation development team to prepare for the clinic and maximize likelihood of successful development.
  • Webinar - Protein Degraders

    Webinar Webinar - Protein Degraders

    Since 2015 the field of targeted protein degradation has rapidly emerged, offering opportunities for novel pharmacological interventions in ways impossible to achieve with traditional small molecule inhibitors. This webinar focuses on cutting-edge drug discovery using protein degraders, such as PROTACS, in diverse therapeutic areas. Attendees can expect to learn about recent strategies toward development of orally bioavailable protein degrader drug candidates—PROTACs and beyond.
    2022-05-06