Polpharma provides a one-stop shopping solution of integrated services ranging from API development to finished dosage formulation and scale-up capabilities based on in-house or customer developed technology and the support of the registration file.
Professional and experienced team of key account managers guarantee customized service package 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.
In addition to a diverse and broad product portfolio of superior quality, excellent customer service and efficient supply chain, Polpharma B2B offers custom-made synthesis service for clients looking for a European manufacturing site for their active substances.
Polpharma B2B 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.
The scope of our services includes also preparation of comprehensive regulatory documentation in an eCTD format. The entire process is led by professional project management team coordinating for you all project activities performed by the R&D, RA, QA and other Operational departments of Polpharma - all of this with the sole purpose of you maintaining a full control over your product.
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.
The enterprise will allow us to expand manufacturing capacity and thus become more flexible when responding to customers’ needs.
The new facility will be compliant with the highest manufacturing standards. Equipment delivered by globally recognized suppliers will ensure 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 – to accommodate for expanding demand of our key products.
Solid state chemistry
Network of Alliances
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.
Polpharma utilizes up-to-date technologies, which ensure the safety of products, employees, and the natural environment.
We have the capabilities...
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.
Comprehensive list of basic processes
|Glass lined||90,000 L 40 reactors||342,000 L 165 reactors|
|Stainless steel||-||25,000 L 15 reactors|
|Auxiliary tanks||-||150,000 L|
|Tank Farm||900 m3||-|
We provide full support from the beginning of cooperation up to the marketing authorization. Registration documentation for API (ASMF, CEP, US DMF, Japanese DMF) is prepared in an eCTD format using the DocuBridge software. Documentation is prepared in accordance with the highest quality standards. It has been submitted and evaluated by authorities from Europe, USA, Japan, Canada, Israel, Australia & New Zealand, Brazil, Mexico, China, India, Egypt, Korea, Singapore, Indonesia, Malaysia, Philippines, Sudan, Vietnam and many others. Head of Polpharma Regulatory Team is an Expert in one of EDQM API Working Groups.
We work in close cooperation with key global health authorities: EMA and EDQM (Europe), FDA and USP (USA) and TPD (Canada) and manufacture our products in agreement with the most rigorous requirements of USFDA, EMA, EDQM, SKFDA, PMDA, ANVISA and Polish Main Pharmaceutical Inspectorate.
New requirements and guidelines appear every year which enforce higher quality of both measuring processes and that of finished API. In order to maintain the position of one of the best on the market, we not only follow requirements but we are ahead of them.
USFDA compliant, EDQM, SKFDA, PMD, ANVISA compliant, Polish GIF compliant
ISO 14001, OHSAS 18001, PN-N 18001
Regulatory documentation (DMF/CEP) recent and restrictive requirement from authorities
Our services include EU standard dossiers for finished dosage formulations based on APIs developed in-house or outsourced. Our out-licensing portfolio secures the most comprehensive offer for our clients.
CONTACT US: email@example.com