Contact Us
We would love to speak with you.
Feel free to reach out using the below details.
Get In Touch
- T : +32 3 886 00 85
- info@purna.be
Adres
PURNA PHARMACEUTICALS
RIJKSWEG 17
2870 PUURS, BELGIUM
A comprehensive solution from API to finished product, Purna Pharmaceuticals caters to all development and manufacturing needs. Adaptable to both turn-key and collaborative projects, we serve start-ups to large pharma with expertise in GMP & FDA (QbD/DoE) compliance, offering full regulatory support.
Our skilled team provides comprehensive development services for pharmaceuticals, medical devices, and cosmetics, all under one roof. With a dedicated project manager as your sole contact, we ensure timely delivery and seamless transition to commercial production without transfer costs or risks.
Purna has in-house a fully GLP-compliant analytical laboratory with a dedicated experienced R&D team offering:
– API characterization (compendial tests, particle size distribution, viscometry, residual solvents, densitometry, polymorphism)
– Method development (UHPLC, HPLC, GC) assay and stability indicating methods
– Method optimization, validation and transfer
– Degradation and stability studies
– Microbiological evaluation
– Dissolution testing
We offer over 30 year of experience in formulation of solutions, suspensions, emulsions, lotions, creams, gels, ointments, pastes, powders and low flash point products. We can help you with:
– Re-formulation or creating innovative new line extensions
– De novo formulation
– Reverse engineering
– Equivalence to reference drug products
– Formulating APIs with complex physical or chemical characteristics
– Cleaning method development
Purna distinguishes itself as a flexible, reliable and transparent partner that will help to find your custom made solution in the development.
During development we will always keep the bigger picture in mind minimizing the risks of failure later on the process.
Developing products for US we are able to follow the QbD (Quality by Design)/ DoE (Design of Experiments) approach, in formulation development and manufacturing.
Purna holds a IMP license for production, packing, labelling, analysis and release of clinical trial material providing small scale productions for pre-clinical studies and supply of cGMP clinical material (Phases I-III)
Building on a team of highly trained and experienced engineers, operators and technicians we offer a manufacturing program that enables seamless transition from lab scale to industrial scale production, development of packaging process (primary and secondary), artwork preparation and including full process, holding, packaging and cleaning validation.
Semi-solids (creams, ointments, pastes and gels) can be upscaled from lab scale to industrial scale from 20L up to 700L and 2000L. Up-scaling (from 20L to 2000L) can be done with the same technology as the type of all vessels is identical.
Liquids can be upscaled from lab scale to industrial scale from 150L up to 1000L, 5000L and 10.000L.
Purna offers stability storage for all ICH climatic zones supporting long term, intermediate, accelerated, photo-stability, transportation, in-use and ongoing (FUST) stability trials.
General APIs, as well as corticosteroids, highly potent, cytotoxic and controlled drugs, are handled within Purna
We would love to speak with you.
Feel free to reach out using the below details.
PURNA PHARMACEUTICALS
RIJKSWEG 17
2870 PUURS, BELGIUM