Security of supply

Security of supply

While working on your Drug Substance, we will take care of the entire supply
chain for all the materials required to secure on-time production and delivery.

  • Well-established and controlled suppliers qualification process:
    • Paper Audit
    • Personal on-site Audit (For Intermediates and selected Regulatory Starting Materials)
    • Risk-based approach.
    • Managed by a separate QA Team dedicated to Suppliers Qualifications.
    • Own a Team of well-trained auditors. Auditors employed by Polpharma have a seat in Asia.
    • Periodic requalification (Every 3 years).
  • A broad network of reliable European suppliers qualified for solvents and basic
    chemicals that are in common use in API production.
  • Wide group of high-quality, GMP-compliant suppliers for Intermediates
    and Starting Materials qualified by Polpharma ready to produce custom
    intermediates on an exclusive basis.
  • Multipurpose lines give flexibility in planning and enable
    to implement your process in different lines as a contingency plan.
  • Experienced Regulatory affairs group supporting clients
    in CMC package preparation for filing
About us Polpharma Group Polpharma API API Manufacturing sites
 

We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from 2024 with full completion scheduled for Q3 2024.

CDMO Competencies & Services Quality Environmental protection Customer experience
 

Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.

Generics Core competencies Products
 

We manufacture our products by following our customers' and health authorities' most stringent requirements. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias.

Technologies Cryogenic High Potent Capabilities
 

We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs) that is proceeding with a $35-million facility expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from Q1 2024, with full completion scheduled for Q3 2024.

Our products

Security of supply

While working on your Drug Substance, we will take care of the entire supply
chain for all the materials required to secure on-time production and delivery.

  • Well-established and controlled suppliers qualification process:
    • Paper Audit
    • Personal on-site Audit (For Intermediates and selected Regulatory Starting Materials)
    • Risk-based approach.
    • Managed by a separate QA Team dedicated to Suppliers Qualifications.
    • Own a Team of well-trained auditors. Auditors employed by Polpharma have a seat in Asia.
    • Periodic requalification (Every 3 years).
  • A broad network of reliable European suppliers qualified for solvents and basic
    chemicals that are in common use in API production.
  • Wide group of high-quality, GMP-compliant suppliers for Intermediates
    and Starting Materials qualified by Polpharma ready to produce custom
    intermediates on an exclusive basis.
  • Multipurpose lines give flexibility in planning and enable
    to implement your process in different lines as a contingency plan.
  • Experienced Regulatory affairs group supporting clients
    in CMC package preparation for filing