A one-stop-shop from API to finished product. From full turn-key development projects to highly collaborative, we can adapt to fit your requirements. Offering expertise in all aspects of the development and manufacture we can take your products from early development to commercial manufacturing, successfully serving small start-ups and large pharmaceutical companies.
Capable to handle GMP & FDA (QbD/DoE) projects and providing you the full regulatory support where needed.
Our experienced team offers the full range of development services for pharmaceuticals (Human & Veterinary), medical devices & cosmetics. A dedicated project manager will be your single point of contact throughout the development process. She/he will ensure that your timelines are met and will send you the necessary information when needed. No transfer costs and risks as all actions are performed at one site, no transfer is needed moving to commercial production.
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.
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.
ICH STABILITY STUDIES
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