API Polpharma is a significant European producer of Active Pharmaceutical Ingredients delivering products to pharmaceutical companies worldwide. We are present on 6 continents, in 60+ countries, and our market share is constantly growing. Our well-balanced and expanding portfolio, along with our scientific know-how and experience, allow us to offer attractive solutions for drug developers.
We provide a one-stop shop solution of vertically integrated services from API development to FDF formulation and manufacturing, scale-up capabilities based on in-house or external custom developed technologies, to regulatory support.
Regular FDA audits enabled us to register and sell a number of APIs in the US market and confirm our reliability and credibility towards our business partners around the world. At Polpharma quality comes first.
Polpharma is founded - manufacturing on Bayer technology
Bayer takes over
Reconstruction of Polpharma after II World War. First product after the war- redistilled water in glass ampoules
Minister of Industry establishes Starogard Pharmaceutical Plant which starts producing salicylates and sulfonamides
Starogard Pharmaceutical Plant Becomes a part of the Union of the Pharmaceutical Industry “Polfa” and is renamed to Starogard Pharmaceutical Works “Polfa”
Polpharma transforms into a Joint Stock Company with 100% shares belonging to the State Treasury and returns to its old name - Pharmaceutical Works POLPHARMA S.A
Spectra Holding and Prokom Investments (Polish capital) buy the majority of the Company shares converting it to a privete company
Strategic alliance with Akrikhin, major generic pharma player in the Russian market
Polpharma becomes a key partner of Chimpharm, Kazahstan
Polpharma becomes a major shareholder of Polfa Warsaw, Poland
Our products are manufactured in accordance with the most stringent requirements of our
customers and health authorities. 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. However, our products can be additionally tested in compliance with the
customer’s specifications.
Quality, optimization and customer satisfaction are the driving forces behind our work
We are responsive to the ever-changing dynamics of global markets. Seeing how rapidly the demand for active pharmaceutical ingredients grows, we decided to significantly increase productivity within this area by investing into a complex modernization of API production lines.
A completely rebuilt and modernized production facility for the production of API was put into operation in February 2017 extending our production capacity.We invest in innovative technologies which enhance production efficiency, the comfort of medication delivery and safety of our processes for humans and the environment
Our newly modernized facility is compliant with the highest manufacturing standards. Equipment delivered by globally recognized suppliers ensures safety of API production in conformity with Polpharma quality standards as well as increasing cGMP requirements. Our production area has been designed to enable parallel manufacturing of API on two additional production lines
Team of key account managers guarantee customized service packages for each client. We are here to advise in project evaluation, educate our clients about our technology and recommend appropriate solutions. We provide assistance in every step of the purchasing process.
The scope of our services includes preparation of comprehensive regulatory documentation in an eCTD format.
The process is performed by the R&D, RA, QA and other Operational departments of Polpharma. All of this with the sole purpose of maintaining full control over your product.
Polpharma API offers full support from process optimization, analytical method development & validation, to process scale-up to pilot plant (kg scale) and fully commercial, multiple tons synthesis in EU cGMP, FDA (US), Anvisa (Brazil), PMDA (Japan) & KFDA (Korea) approved facility.
Full support from molecule development to drug delivery
Development and production of generic APIs
Custom synthesis and toll manufacturing
Intellectual Property expertise and guidance
Regulatory compliance
Process upscaling
Development of new salts and polymorphic forms of APIs
Adjusted particle size distribution (PSD)
Non-infringing process development
Multipurpose production lines
High GMP standards
High quality products
Excellent service
Wide reaction classes in FDA approved facilities
Offer custom-made synthesis and individual approach to non-standard queries and projects
Our prime assets are the knowledge and extensive expertise of our people.
A
key to the success is a combination of in-house expertise and effective co-operation with
scientific institutions.
Our company enjoys the benefit of the experience of specialized external laboratories and institutions both Polish and international, the majority of which are located in Germany, Italy, Sweden, Switzerland, The Netherlands, China and India.
The external cooperation is carried out in the following areas:
To implement wide regulations into our processes, we developed the following practices:
We provide full support from the beginning of cooperation to the marketing authorization. We assist customers through the entire registration lifecycle process. All deficiency letters from regulatory agencies are treated with highest priority to provide full responses before deadline.
Our registration documentation for APIs (ASMF, CEP, US DMF, JAPANESE DMF, CHINESE DMF) is prepared in an eCTD format using the software DocuBridge. It has been submitted and evaluated by authorities from: Europe, USA, Japan, Canada, Israel, Australia &New Zealand, Brasil, Mexico, China, India, Egypt, Korea, Singapore, Indonesia, Malaysia, Philippines, Sudan, Vietnam and many others.
We work in close cooperation with key global health authorities.
Global Authorities: US FDA compliant, EDQM, SKFDA, PMD, ANVISA compliant, Russian MIT, Polish GIF compliant
ISO: ISO 14001, OHSAS 18001, PN-N 18001
REGULATORY DOCUMENTATION: EU DMF/ CEP, US DMF, Chinese DMF, Japanese DMF, Korean DMF
Respecting all third party intellectual rights, our own patent team is dedicated to designing and defending our processes. We are experienced in designing new synthesis routes for producing APIs; our patent portfolio proves it.
The use of hazardous chemistry has an aim to reduce the number of synthesis steps as well as the amount of impurities. Our key hazardous chemistry includes:
Equipment type:
Operating ranges:
Operating ranges Pilot Plant:
Polpharma is engaged in efforts to make its environmental contribution more extensive than ever. We pledge to contribute to a sustainable future for the environment through technological innovation that reduces pollution. We follow the European ISO Standards.
Polpharma utilizes up-to-date technologies, which ensure the safety of products, employees, and the
natural environment.
We have the capabilities to provide customers with materials ranging from clinical quantities up to
in-market supply. We have full and vertical integration of processes from R&D, pilot plant, scale-up
to the manufacturing leverage of our competences in place so that cost-effective and on-time
solutions are delivered to our partners. API manufacturing is carried out in cGMP-compliant and
FDA-approved multipurpose plant.