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PolyCrystalLine S.p.A

About PolyCrystalLine S.p.A

As Polycrystalline CDMO we see ourselves as your strategic partners, with our reliability and our full commitment to meet your need into the development of new APIs and HPAPIs we want to unlock the full potential of our partnership going beyond the classic client/supplier relationship.
Our recent investment is aimed to meet and outmach your expectations, our innovative technologies, our custom made plant , our highly skilled scientisst and our continuous reaserch to reach the excellence are just some of the keys of Polycrystalline CDMO.

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Certifications
  • FDA
    FDA
  • GMP
    GMP
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Sales Markets
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Categories
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  • IT
  • 2015
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
CMO/CDMO
Contract Service
Primary activities
API Producer
Contract Research Organisation
Custom Manufacturing/Custom Synthesis
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Contact info
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Meet us at

CPHI Frankfurt 2025

Messe, Frankfurt
28 Oct 2025 - 30 Oct 2025
View Exhibitor Profile

Products from PolyCrystalLine S.p.A (18)

  • cGMP Manufacturing

    Product cGMP Manufacturing

    Our new small molecule API custom manufacturing capabilities integrated with our R&D facility will allow PolyCrystalLine CDMO to bring your project from early phase development to scale-up and commercial manufacture ensuring the right solid forms. We have been doing this for many years. PolyCrystalLine CDM...
  • Process Development

    Product Process Development

    We can optimise synthesis and crystallization processes, ranging from synthetic route scouting to process scale-up allowing for batches of grams to kilograms of small-scale production, while ensuring flexible and robust procedure that can easily be transferred to pilot-scale, and finally to high volume ind...
  • Api-Excipient Compatibility Studies

    Product Api-Excipient Compatibility Studies

    PolyCrystalLine offers a wide range of Pre-formulation studies which includes API-excipient compatibility studies. It contains excipients which can affect the chemical, physical and therapeutical properties, product stability and may even cause a change in the API polymorphic form. Its interactions is a cr...
  • Cgmp Quality Control

    Product Cgmp Quality Control

    PolyCrystalLine offers a wide range of analytical services which includes cgmp quality control. Its provide a full complement of state-of-the-art gmp analytical testing resources and expertise to support cgmp quality control testing for raw materials, active pharmaceutical ingredients (api) and intermediat...
  • Co-Crystals Screening

    Product Co-Crystals Screening

    PolyCrystalLine offers a wide range of solid form screening which includes co-crystals screening. It is an molecular crystals in which at least one of the compounds is an active pharmaceutical ingredient (api). Salts are considered different from co-crystals provided that its crystals formed by ionic multi...
  • custom synthesis

    Product custom synthesis

    Api and impurities
  • Dissolution Testing

    Product Dissolution Testing

    PolyCrystalLine offers a wide range of Pre-formulation studies which includes Dissolution testing. It is a Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution or solubilisation of the drug under physiological...
  • In Vitro Bioequivalence Studies

    Product In Vitro Bioequivalence Studies

    PolyCrystalLine offers a wide range of Pre-formulation studies which includes In vitro bioequivalence studies. It is considered as a surrogate for clinical evaluation of the therapeutic equivalence of drug products based on the fundamental bioequivalence assumption that when two drug products are equivalen...
  • Kilo-Lab

    Product Kilo-Lab

    Kilo Lab, available for HPAPI, narcotic or controlled substances, pressure reactions
  • Method Development & Validation

    Product Method Development & Validation

    PolyCrystalLine offers a wide range of analytical services which includes method development & validation. It can be entrusted with the most sensitive projects for method development and validation of api’s intermediates, raw materials and finished products. Contact us for more information.
  • Physical Characterization

    Product Physical Characterization

    PolyCrystalLine offers a wide range of analytical services which includes physical characterization. Its an physicochemical properties of a compound is essential so that the formulation process can be rational and streamlined. Contact us for more information.
  • Polymorph Screening

    Product Polymorph Screening

    PolyCrystalLine offers a wide range of solid form screening which includes polymorph screening. In an early stage of drug development helps to avoid manufacturing problems, to fine-tune the performance of drugs and provides space for innovations. Contact us for more information.
show all 18 products

PolyCrystalLine S.p.A Resources (1)