HTBT has two small-capacity injection workshops, a packaging workshop, and an oral capsule workshop (under construction) for the production of injection production.
One of the two small-capacity injection workshops is Formulation & Filling I, which covers about 500 m2 and is designed and built in accordance with the CFDA GMP standards. Formulation & Filling I, with one integrated washing, filling and capping line, the ability of producing cartridges and vials and a designed capacity of 12 million /year, has been put into use, and has completed process validation and production of injection products such as recombinant human insulin products (cartridges and vials), novel long-acting insulin analogue injection (cartridges), and recombinant insulin glargine injection (cartridges).
Formulation & Filling II covers about 900 m2 and is designed and built in accordance with the EU GMP standards. There are two automatic washing, filling and sealing line for cartridge and vials production respectively in Formulation & FillingIIwith a designed capacity of 60 million /year, and all the production equipments are imported equipment in line with the American and EU standards, laying firm foundation for the future development of European and American markets. The packaging workshop covers 630m2, and adopts imported automatic production equipment linked with light inspection and packaging, with the packaging ability of both packaging cartridges and vials. It is the supporting workshop that provides services for Formulation & Filling I and II.
Moreover, we have an oral insulin capsule preparation in the development stage. The product has passed through the United States' FDA clinical phase II, and the workshop is in the design and construction stage.
The company has introduced advanced Israeli production technology, upheld the production concept of excellence and efficiency, strictly complied with the GMP requirements, adhered to the quality policy of "quality first, continuous improvement, scientific management, and pursuit of perfection" and built a rigorous, executable core team to provide safe and effective quality products for patients.