Strategic investment HP API facility

As an EU-based
Contract Development and Manufacturing Organization (CDMO) and supplier
of active pharmaceutical ingredients, we are advancing our technology
capabilities with an Occupational Exposure Limit (OEL) as low as 10
ng/m³ (OEB 6).
Our new capabilities enable GMP and FDA-approved
kilo-scale production, offering batch sizes of up to 1.5 kg. This
facility features dedicated Analytical Development Laboratories (ADL)
and Process Development Laboratories (PDL) to ensure comprehensive
support for all production phases. The design incorporates
state-of-the-art isolator technology to ensure the safety of both
personnel and products, along with industry-standard secondary
containment solutions integrated into the infrastructure.
We have
secured future capacity expansion through both internal enhancements and
external partnerships, with the goal of doubling our production
capacity.
Polpharma S.A.

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PL
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2015On CPHI since
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4Certificates
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5000+Employees
Other Content from Polpharma S.A. (4)
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News CPHI Barcelona 2023: Tackling the Pharma Talent Precipice – Part 2
This year at CPHI Barcelona (24–26 October, 2023) we sat down with C-suite executives and HR professionals to discuss the looming talent crisis in the pharmaceutical industry. With hybrid working persisting post-pandemic and a growing skills gap, how can the pharmaceutical supply chain adjust to a changing labour force? -
Brochure API Product List 2025
Thanks to over 70 years of experience in process development, scale-up and cGMP manufacturing, we support both emerging and established pharmaceutical customers in the development and commercialization of their small molecule API clinical candidates. At our FDA-approved plant located in Central Europe, we provide end-to-end solutions from API development to scale-up allowing smooth process transfer for commercial-scale manufacturing capabilities, with world-class regulatory support. Our strong R&D management team, experienced in the development of chemical processes and complex projects, provides a wide range of solutions to our customers, applying a variety of chemical reactions and conditions, including cryogenic, High Pressure, strong base reactions, and tailor-made particle size distribution modifications. At Polpharma quality comes first. Regular FDA audits prove our reliability and credibility towards business partners around the world.
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News KiloLab Laboratory: strategic milestone achieved!
KiloLab Laboratory – a development and production in a kilogram scale – has been launched, according to Polpharma API development strategy adopted in 2021. -
Brochure Polpharma API CDMO offer
Thanks to over 70 years of experience in process development, scale-up and cGMP manufacturing, we support both emerging and established pharmaceutical customers in the development and commercialization of their small molecule API clinical candidates. At our FDA-approved plant located in Central Europe, we provide end-to-end solutions from API development to scale-up allowing smooth process transfer for commercial-scale manufacturing capabilities, with world-class regulatory support. Our strong R&D management team, experienced in the development of chemical processes and complex projects, provides a wide range of solutions to our customers, applying a variety of chemical reactions and conditions, including cryogenic, High Pressure, strong base reactions, and tailor-made particle size distribution modifications. At Polpharma quality comes first. Regular FDA audits prove our reliability and credibility towards business partners around the world.
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