Chemical drug CMC research: Conduct preclinical research on drug properties, structure, dosage form, prescription, process, quality and stability, and provide generic drug consistency evaluation services.

The institute provides full-process sample trial production services from laboratory to production. Relying on advanced R&D equipment and an experienced technical team, it can undertake small-scale, pilot and clinical sample preparation of various dosage forms (solid preparations, liquid preparations, semi-solid preparations, etc.). It supports g to kg level sample preparation to meet the needs of different R&D stages. It is equipped with a variety of process equipment such as wet granulation, dry granulation, fluidized bed one-step granulation, mixing, tableting, capsule filling, laser drilling, homogenizer, etc., with immediate release dosage forms, sustained release dosage forms, enteric solvent-coated tablets, sugar-coated tablets, osmotic pumps, micropellet controlled release systems, hard capsules (fillable powders, granules, micropellets, microtablets), gels, creams, suspensions, etc.

The institute has rich product experience in solid preparations, liquid preparations, and semi-solid preparations, as well as complete testing equipment and inspection methods, and can conduct extensive project testing and method development for related preparations.

Testing of powder properties (such as particle size research, fluidity evaluation, etc.)

Rheological properties testing

Testing of physical and chemical properties of preparations (such as appearance, moisture, density/viscosity, etc.)

Content testing (such as active ingredient content, impurity content, etc.), dissolution/release testing

Stability testing

Packaging system sealing testing

The institute has a professional registration team and clinical team. Suzhou Chung-Hwa has obtained more than 100 production approvals through self-organization and implementation. At the same time, it has also successively undertaken a number of import registrations (preparations and raw materials) approved by the headquarters, so it has the ability to undertake overseas drug import registrations.

The institute integrates a variety of precision analytical instruments (HPLC, UPLC, fiber optic dissolution instrument, rheometer, etc.) and a variety of trial production equipment (wet granulator, fluidized bed, multi-layer tablet press, laser puncher, etc.) in the laboratory, and opens them up for sharing with pharmaceutical companies, research institutes and innovation teams. It realizes efficient utilization 24/7 and significantly reduces the equipment procurement and maintenance costs of users.