Polpharma API | Polpharma API

Polpharma API is part of Poland's leading multinational pharmaceutical group, with more than 90 years of experience serving patients and business partners worldwide. As a CDMO specializing in small molecule APIs, the company leverages over 75 years of expertise in process development, scale-up, and cGMP manufacturing to support both emerging and established pharmaceutical companies from clinical development through commercial production.

Operating from an FDA-approved manufacturing site in Central Europe, Polpharma API provides end-to-end services covering API development, process scale-up, technology transfer, commercial manufacturing, and regulatory support. Its experienced R&D team specializes in complex chemical process development, offering expertise in cryogenic reactions, high-pressure chemistry, strong base reactions, and tailored particle size distribution modifications.

Quality is at the core of the company's operations, with regular FDA inspections demonstrating its commitment to regulatory compliance and manufacturing excellence. Supported by highly qualified experts and state-of-the-art facilities, Polpharma API delivers reliable and flexible solutions for global pharmaceutical partners.

As one of Europe's leading CDMOs, the company offers comprehensive development and manufacturing capabilities across a broad range of advanced technologies, including:

• High-potency APIs (HPAPIs)
• Payloads and linkers
• Oligonucleotides
• Cryogenic processes