The renowned, back-integrated manufacturer for innovative and High-End Pharmaceuticals, delivering value-added products and services.
From Advanced Intermediates through Finished Dosage Forms, our Multi Purpose Technology Platform, gives us the flexibility to produce a broad product portfolio and meet clients’ specific needs for new developments and projects – in full compliance with international cGMP.
With a Development Team of experts that is capable of meeting the challenges of complex Multi Stage Chemistry, PEN TSAO provides its clients with innovative and cost optimized solutions.
Process evaluation and development with goal to minimize costs and development time.
Patent evaluation and route scouting.
Upscaling, technical transfer and validation of production processes.
Appropriate application of GMP and regulatory requirements to ensure highest quality standards.
Product registration, stability studies and other regulatory services.
Development and validation of analytical methods including inprocess controls.
Stability and impurity profiling.
Synthesis and characterization of impurities.
Elaboration and submission of Drug Master Files or other regulatory documents (we are approved by SFDA, PMDA, KFDA, DCGI India, Russia and various European Authorities).
Supplier qualification and auditing (materials and services).
Besides the essential analytical and physical testing equipment for the development of Oral Solid Dosage Formulations (OSD) in our formulation laboratories, our plant is completed with storage facilities for Raw Materials, In-Process Materials and climate controlled API storage. PEN TSAO has all permits and licenses for the operation of a Multi-Purpose Facility in China.
Aside from our already established list of APIs, our current development of Specialty APIs will further strengthen our market position. Along with our formulations, they make up a major part of our growth strategy internationally as well as in the Chinese market.
Preparing for growing demands in China and the rest of the world, Rodallis BioPharma Co. Ltd. was founded with the intent of entering the fast growing Pharma market with its own OSD formulations based on various niche APIs. Therefore, a plot of 3,5 ha was recently acquired in Pinghu, Zhejiang, China.