Polpharma API CDMO

Yes. Our site is FDA-approved, with successful inspections completed in 2004, 2009, 2012, 2015, and 2018. We are also regularly inspected by other major global regulatory authorities, including EMA/PIC-S members, Japan's PMDA, Brazil's ANVISA, and Korea's KFDA. Our GMP certificates are registered in the EudraGMP database.

We operate a pharmaceutical quality system built in accordance with current cGMP and EU GMP Part II (ICH Q7) guidelines. Our independent Quality unit maintains final authority on all quality decisions, quality risk management follows ICH Q9, and deviations, CAPAs, change controls, complaints, and product reviews are managed using TrackWise.

We register every deviation in TrackWise, communicate it immediately to the customer and project teams, and investigate to determine impact and root cause. We keep the customer informed about the status of the investigative activities; the customer has the opportunity to participate in these activities, approves the summary, and jointly defines the CAPA. We assign, implement, and verify corrective and preventive actions, while monitoring quality trends monthly across all operations.

Yes. We welcome a full quality audit from clients once per calendar year with 30 days' notice, and accommodate immediate for-cause audits whenever necessary. We keep you informed of, and invite you to attend, regulatory inspections involving your product.

We maintain validated computerized systems with role-based access, audit trails, automated backups, and controlled data changes under a formal data integrity SOP. We retain batch documentation for at least eight years and can return project-specific records upon request under our Quality Agreement.

Our site is regularly inspected by the Polish Main Pharmaceutical Inspectorate, a PIC/S member with mutual recognition with the US FDA. For ANDA filings, the FDA accepts GMP inspection reports issued by the Polish authority, generally eliminating the need for a separate facility inspection and reducing regulatory timelines.

We hold ISO 14001 (environmental management) and ISO 45001 (occupational health and safety) certifications, alongside an EcoVadis Silver rating (74/100). Our laboratory practices align with ISO/IEC 17025, and we operate under a comprehensive Group Environmental Policy and Sustainable Development Strategy.

We have approximately 370 m³ of installed capacity across 227 reactors (ranging from 5 to 6,300 liters), including over twenty 4,000-liter and 6,300-liter vessels. Our commercial batch sizes run from 30 to 800 kg, comfortably supporting annual volumes from 500 kg at launch to 2,800–4,500 kg at peak demand.

We deliver end-to-end CDMO programs for global partners, taking on an average of four new projects each year. Our experience spans small molecules, high-potency compounds, GMP oligonucleotides, and ADC payload-linkers. Over the past three years, we completed five first-time scale-ups, eight process optimization projects, and four validation readiness developments.

Our R&D organization of around 86 experts covers process development, analytical development, and regulatory affairs, including 21 PhD-level scientists. We offer extensive in-house analytical testing: HPLC/UPLC, XRPD, DSC, TGA, LC-MS, GC, ion chromatography, Karl Fischer titration, microbiological testing, method development/validation, and stability studies. We specialize in impurity characterization (including nitrosamines and genotoxic impurities), supported by qualified external labs for ICP-MS and NMR.

Yes. We perform cryogenic chemistry down to −90 °C, catalytic hydrogenation, Grignard reactions, lithiation, bromination, triflation, and high-vacuum distillation. Every hazardous reaction step undergoes formal process safety evaluation before scale-up, backed by custom containment and safety systems.

We offer jet milling to d90 < 10 µm and contained pin-milling for potent compounds to d90 < 15 µm (30–40 kg/h), alongside micronization and lyophilization. Our dedicated solid-state chemistry lab supports polymorph screening and controlled crystallization to ensure your desired particle size distribution and crystal form.

We prioritize clear, proactive communication throughout every project. A dedicated project manager leads weekly or bi-weekly meetings and provides written summaries covering progress, upcoming activities, and risk management so you always know where your project stands.

Yes. You work directly with the scientists and project leads responsible for your molecule, rather than navigating sales layers. Because our R&D, kilo labs, pilot plant, and commercial production sit on a single site, answers come straight from the experts performing the work.

We flag challenges early. If raw material delays or unexpected results threaten the project timeline, your project manager will promptly present transparent solutions and mitigation options. We focus on active problem solving and keeping decisions firmly in your hands.

Technology transfer begins early with analytical method transfer and process familiarization. With development and commercial manufacturing co-located on one site, knowledge transfers seamlessly between teams. Your project manager will establish a tailored, efficient tech transfer plan right from the outset.

We establish a Quality Technical Agreement (typically within 30 days of project signing) to clearly outline responsibilities. Project parameters — including communication schedules, document sharing, audits, and confidentiality — are defined upfront and managed by your assigned project manager.

We actively steer projects to prevent timeline drift. Our project managers build contingency plans for key risks, review project scope against real-time laboratory data to avoid scope creep, and adjust courses early to keep your project moving smoothly toward final delivery.