API INTERMEDIATE SERVICES
API and intermediates process development services
API and intermediates manufacturing services
Registration Filing and Regulatory Services
Learn how Hiray Pharma shares their proprietary technology with you.
Non-GMP/GMP pilot and commercial production
Hiray Pharma currently has a production base in Jingmen, Hubei Province, and closely cooperates with the company's three R&D centers in Tianjin, Wuhan and Xiamen to provide customers with integrated services from CRO to clinical batch, and to commercial batch production, and can provide starting materials and API products as demand by weight.
As for the design and construction of Hiray Pharma's multi-functional workshop, the workshop has good versatility and flexible production capacity, which can achieve rapid product switching, so as to ensure the timely delivery of CRO and clinical batch product time-sensitive customers. Relying on the international standard quality system and large-scale commercial GMP product production experience, we can provide customers with high-quality commercial API and GMP intermediate products at the best cost, and provide customers with a series of additional services such as secondary process development and optimization.
GMP area has 7 production workshops, including 3 multi-functional workshops and 4 special product commercialization workshops. The non-GMP area plans 6 non-GMP workshops to meet the raw material needs of the front-end of the factory.
The first phase was put into use two multi-functional GMP workshops, the reactor volume is 256.3 cubic meters, which can achieve a high temperature of 250 °C, and low temperature of -80 °C, and has a domestic leading GMP hydrogenation reaction unit, with 300L-5000L hydrogenation reaction equipment of different specifications, the maximum production pressure can reach 10MPa.
Hiray Pharma has established a high activity laboratory in the R&D center, which is designed according to OEB5 (OEL less than 1μg/m3).
Hiray Pharma has established commercial production capacity for highly active compound GMP OEB5 (OEL less than 1μg/m3) at Hiray production site by using various engineering control methods.
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