The vertically integrated Pharma Group serving China and the World.
RODALLIS BioPharma Co. Ltd. was established in order to meet the growing demand for APIs in China and internationally, and to take advantage of the rapidly expanding Pharma market by producing OSD formulations using a variety of their own unique APIs. Accordingly, they acquired a 3,5 hectare plot in Pinghu, Zhejiang, China, easily accessible from both Shanghai airports by car within one hour.
The acquisition includes a Multi-Purpose Production facility with a capacity of 270 tons for small molecule API production, as well as a Formulation facility for 70 tons of OSD drug production.
Dushan Port Economic Development Zone, Pinghu, Jiaxing County, Zhejiang
110 km south of PEN TSAO, Shanghai, 65 km south of Hongqiao Hub, 90 km from Pudong Intl. Airport and 3 km south of Shanghai Jinshan Chemical Park.
Our answer to the growth potential of the PEN TSAO Group in China and international markets is the large expanded Multi-Purpose production current under construction at RODALLIS BioPharma in Pinghu. When completed, qualified and validated the site is ready for inspection by SFDA, EDQM, US-FDA, PMDA, PQP-WHO, ANSA and other inspectorates.
The first phase of an installed reactor volume of 150 m³ with total 15 Glass-lined Multi-Purpose Reactor Units and 15 Stainless Steel (SUS 316L) Multi-Purpose Reactor Units ranging from 1,000l to 6,300l as well supporting vessels.
A total designed reactor capacity of 218 m³.
6 Clean-Room Class D Final Treatment suites for the last step API production.
12 fully automatic Horizontal Peeler Centrifuges, 10 Vacuum dryers, various Filter types and Homogenization, Grinding and Milling Equipment.
The plant is completed with a Multi-Stage Waste water treatment facility and a Regenerative Thermal Oxidizer (RTO) Waste Gas treatment System. Liquid and Solid waste pre-storage space for third party external treatment are set up. The Site fulfills latest China and International Safety and Environmental Regulations and is prepared for inspections beside SFDA China by international stringent cGMP-regulated countries.
The API facilities for RODALLIS will be operational in late 2024.
The newly acquired formulation facilities will provide the capacities for niche Oral Solid Dosage (OSD) drug production, marketed by RODALLIS BioPharma and distributed both in China as well as internationally. Our ever-expanding portfolio currently includes the following OSD formulations: