Formulation Development

Formulation Development
Product Description

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.

Pre-formulation & Discovery Support

  • Solubility, stability, compatibility, logP testing
  • Solid form screening & selection
  • Physicochemical profiling, drug ability assessment
Formulation & Process Development
  • Process development based on physicochemical and physical properties of drug candidates
  • Storage and shipping conditions assessment of drug candidates
  • Technology transfer of formulation and manufacturing process to clinical manufacturing sites
  • CMC document preparation for IND/NDA/ANDA submission
Filing Document Preparation
  • CMC document preparation and regulatory support
  • NMPA/FDA/EMA/TFDA dossier filling support
Pre-formulation Development
  • pH/Aqueous Solubility
  • Solid state characterization
  • Intrinsic Properties Profiling & Dissolution
  • Polymorph screening
  • Salt screening
  • Co-crystal Screening
  • Crystallization Process
  • Amorphous Solid Dispersion Development
  • Micronization
  • Nano-suspensions
  • Evaluation at Lead Selection / Early Tox stage
  • Reduce drug/taste bud interaction utilizing API-excipient Complexation strategies
  • Improve taste profiles of Orally Dispersible Tablets (ODT) by suspension & multiple/dual emulsion technologies
  • Protect against salivary pH response by application of stimuli-responsive coatings
  • Functionally coat your drug using Reverse Enteric Polymers
Pediatric Dosage Deliver


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


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

More Products from BioDuro-Sundia (4)

  • Drug Product Manufacturing

    Product Drug Product Manufacturing

    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 excepti...
  • 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...
  • 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 (3)

  • 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.
  • 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 
  • 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.