R&D

Our Expertise

Development and commercialization of new, attractive APIs is the priority of the POLPHARMA API R&D Department. The key to our success is the combination of experience and expertise of our own research team as well as effective co-operation with scientific institutions.

We deliver a broad range of added value services to your business:

  • First generic launch - Technology development strategy for IP-regulated markets

  • Technology development strategy for early launch in non-IP and non-regulated markets

  • API differentiation – Solutions for new or mature API for line extension as well as generic launch in line with innovator (solid state chemistry, pro-drug, chiral compounds, adducts) in FDF development

Highly qualified Professionals in technology development as well as in development in the field of Solid State Chemistry are employed in API R&D Department:

2 1 PhD

R&D Managment
& Planning

22 5 PhD

Analytial Development

13 5 PhD

Technology Development
Section

13 2 PhD

Regulatory Affairs
Department

A continuous innovation approach in product life cycle management

Process
Chemistry

  • Process Development

  • QbD

  • Green Chemistry

  • Process Engineering

  • Regulatory Support

  • Continuous improvement

Crystal
Morphology

  • Particle size engineering

  • Controlled crystallization

  • In-process particle size distribution measurement

  • Micronization/jet milling

Quality
Standards

  • Impurities Profile

  • Outstanding Quality Compliance

  • Quality Management System

Facilities

  • FDA Approved facilities

  • ISO 14001 and 18001

  • Scale-up capabilities

  • Time to market

  • Agile supply chain

Our Capabilities

PROCESS DEVELOPMENT SECTION

ANALYTICAL DEVELOPMENT SECTION

  1. 1

    Regular Organic Chemistry processes (coupling, condensation, oxidation, reduction, solvolysis etc.)

  2. 2

    Phosphorous Chemistry (e.g. Bisphosphonates)

  3. 3

    Organometalic Chemistry (lithium, magnesium)

  4. 4

    Catalysis (phase transfer catalysis, heterogenous and homogenous)

  5. 5

    Catalytic Hydrogenation

  6. 6

    High pressure reactions (up to 150 bar)

  7. 7

    Aminoacids and Peptide Chemistry (solution and solid-phase synthesis)

  8. 8

    New polymorphs, salts, co-crystals, co-precipitates and adducts development

  9. 9

    Solubility and permeability improvement

  10. 10

    Particle size engineering

  1. 1

    Development & Validation of analytical methods for starting materials, intermediates and API

  2. 2

    Transfer & Verification of analytical methods

  3. 3

    Impurity identification, characterization and profiling including genotoxic, nitrosoamines and elemental impurities

  4. 4

    Degradation studies

  5. 5

    Hygroscopicity studies

  6. 6

    Stability & Storage studies, including Photostability

  7. 7

    Polymorph identification & characterisation

  8. 8

    Particle size analysis

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