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Polpharma - CDMO/CMO

Polpharma API is a part of Polish leading multinational pharmaceutical group trusted by millions of patients and business partners for over 85 years. Polpharma API CDMO. 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...

Address: ul.Pelplińska 19, 83-200, Starogard Gdanski
Poland
Poland Local time:

Largest Polish manufacturer of pharmaceuticals and a leader of the Polish pharmaceutical market.

FDA approved european manufcaturing facilities

Export APIs to more than 60 countries worldwide

Our services:

Drug Substance

Production scale:

medium

Response time:

Facilities

Micronizer (Jet Mill) 5cm diameter
Micronizer (Jet Mill) 5cm diameter
Discharge of nutshe-fitler
Discharge of nutshe-fitler
Vertical axe SS centrifuge
Vertical axe SS centrifuge
Crystalizers
Crystalizers
Dissolutors
Dissolutors
Facilities
Facilities

Our Pilot Plant is an independent, small scale FDA approved production facility counting more than 25 reactors and vessels from 50 to 650 L for a total of 6 m3 capacity.

3 different and fully segregated clean zones for final APIs processing enable 3 parallel projects to run independently. Pilot Plant operations are designed and maintained an exactly the same standard as the production environment at the target commercial scale, which ensures a smooth process transfer at a larger scale (same quality, EHS standards, format for Batch records and SOP’s are applied as for production areas).

This facility runs 24h/day and 7 days/week and giving its capacity and flexibility is used for both scale-up studies to prove process robustness and also routine manufacturing of relatively small volume commercial API. Polpharma's efforts in cost-efficiency and innovation ensure the continued...



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Employees:
455+
Established in:
1951

Latest updates

Ryvu Therapeutics and Polpharma sign two agreements in the area of RVU120 API production for Phase II clinical trials

Ryvu Therapeutics and Polpharma sign two agreements in the area of RVU120 API production for Phase II clinical trials

Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology and Zakłady Farmaceutyczne Po

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Another Polpharma API strategic milestone achieved!

Another Polpharma API strategic milestone achieved!

Another Polpharma API strategic milestone achieved! ‍ KiloLab Laboratory - a development and production in a kilogram scale - has been launche

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First CADIFA certification from ANVISA for Etodolac

First CADIFA certification from ANVISA for Etodolac

In the dynamic landscape of pharmaceutical regulations, Brazil took a significant stride in April 2020 when ANVISA unveiled new rules about active pharmaceutical ingredients (APIs). Fast forward to Au

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Rising Prevalence of Cancer and Its Impact on the HP API Market

Rising Prevalence of Cancer and Its Impact on the HP API Market

Cancer cases are expected to increase by 61% by 2050, particularly in lower-income countries. This alarming trend underscores the urgent need for more effective and targeted treatment options. In resp

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Polpharma Group's environmental responsibility

Polpharma Group's environmental responsibility

We understand that a healthy world that we strive to contribute to through our mission includes a healthy environment. As a manufacturing company, we are committed to reducing our environmental impact

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An Overview of Breast Cancer: Understanding Risks, Treatments, and Market Trends

An Overview of Breast Cancer: Understanding Risks, Treatments, and Market Trends

Breast cancer is a disease characterized by the uncontrolled growth of cells in the breast tissue. It is the second most common cancer type overall, and the most prevalent cancer among women worldwide

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Polpharma's HP API facility is live!

Polpharma's HP API facility is live!

An extraordinary investment in the API sector - a new facility adapted to work with highly potent active pharmaceutical ingredients (HP API), the first and only of its kind in Poland.

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Addressing Nitrosamine Risks in Pharmaceutical Manufacturing

Addressing Nitrosamine Risks in Pharmaceutical Manufacturing

In the relentless pursuit of excellence and delivering top-quality products, the pharmaceutical industry often relies on established facts and practices. However, thi

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A Comprehensive Overview and Prognosis of the Diabetes Market

A Comprehensive Overview and Prognosis of the Diabetes Market

Diabetes is one of the most serious health problems in the modern world.

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Welcoming Pere Mañé as Suanfarma’s New CEO

Welcoming Pere Mañé as Suanfarma’s New CEO

Suanfarma Appoints Pere Mane as New CEO to Drive Industrial Growth and Global Expansion

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Upcoming events

DCAT 2025

DCAT 2025

In-person event

17-03-2025

World ADC London 2025

World ADC London 2025

In-person event

03-03-2025

CEBioForum

CEBioForum

In-person event

02-04-2025

Learn more
IOPC Prague

IOPC Prague

In-person event

09-06-2025

Learn more
BIO International BOSTON

BIO International BOSTON

In-person event

16-06-2025

Learn more
World ADC San Diego

World ADC San Diego

In-person event

03-11-2025

CPHI WW 2025 Frankfurt

CPHI WW 2025 Frankfurt

In-person event

28-10-2025

CPHI China 2025

CPHI China 2025

In-person event

24-06-2025

Services

  • New chemical routes full development
  • Process optimization
  • Technical transfer
  • Analytical methods development, transfer, validation
  • Troubleshooting
  • Crystallization studies
  • Particle size distribution control

Our Pilot Plant is an independent, small scale FDA approved production facility counting...

Drug Substance (CDMO/CRO)

Biologics are complex medicines derived from living cells, used in treating diseases such as cancer, autoimmune disorders, and more. CDMOs specializing in biologics offer capabilities in cell line development, upstream/downstream processing, and sterile fill-finish.
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Fine chemicals are pure, complex chemicals produced in limited quantities for use in pharma and biotech. CDMOs offer synthesis, scale-up, and high-purity manufacturing to support drug substance production.
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Pharmaceutical intermediates are compounds used in the production of APIs. CDMOs play a crucial role in synthesizing, scaling, and ensuring the quality of these intermediate compounds to support efficient drug manufacturing.
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Peptides are short chains of amino acids with therapeutic potential across endocrinology, oncology, and metabolic disorders. CDMOs offer synthesis, purification, and formulation services tailored to peptide APIs and drug products.
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Small molecule APIs form the backbone of many pharmaceutical drugs due to their low molecular weight and ease of synthesis. They are widely used in treating a range of diseases and are typically produced through chemical synthesis in GMP-compliant facilities.
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Contact Polpharma for Contract Services Expertise

Connect with Polpharma, a leading pharmaceutical company from Poland. They offer specialized Drug Substance (CDMO/CRO). Contact Polpharma for free and discover if they are the perfect partner for your pharmaceutical needs.

Drug Substance (CDMO/CRO)

Drug Substance CDMOs and CROs provide essential services in the development and manufacturing of active pharmaceutical ingredients (APIs). These organizations specialize in early-stage research, process development, and GMP-compliant manufacturing of drug substances for clinical and commercial use.


Pharmaoffer's Drug Substance CDMO/CRO category includes partners with expertise in small molecules, biologics, peptides, and complex chemistry, all operating under strict regulatory compliance. These providers help companies scale from lab to market efficiently and cost-effectively.


Key Functions of Drug Substance CDMOs/CROs:


  • API Research and Development: Providing early-stage discovery support, custom synthesis, and process optimization to streamline the development of drug substances.

  • Process Scale-Up and Tech Transfer: Transitioning from bench-scale to pilot and commercial scale production with validated methods and reproducibility.

  • GMP Manufacturing: Delivering high-quality API batches in GMP-certified environments, adhering to FDA, EMA, and other international standards.

  • Analytical Services: Offering comprehensive analytical method development and validation to ensure consistent quality and regulatory compliance.

  • Flexible and Specialized Capabilities: From small molecule synthesis to biologic and peptide manufacturing, these partners provide specialized services tailored to product-specific needs.


Explore Leading API CDMOs and CROs

Pharmaoffer connects you with trusted CDMOs and CROs for drug substance development. Our platform enables seamless access to specialized service providers equipped to support your API lifecycle from discovery to commercialization.

Polpharma


Polpharma API is a part of Polish leading multinational pharmaceutical group trusted by millions of patients and business partners for over 85 years. Polpharma API CDMO. 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. Our team of highly qualified, skilled and enthusiastic experts combined with state-of-the-art equipment and facilities provides our partners with an outstanding customer experience. Polpharma API. Your European CDMO partner.