Anhui Poly Pharm. Co., Ltd.

Anhui Poly CDMO

The company has 3 API production workshops that meet the Chinese, USA and EU GMP, and can provide customized services such as ordinary synthesis, clean area, biosynthesis, and high activity. There are 150 30L~5000L reactors provided for 8 production lines, and more than 200 pieces of other equipment.

Separation equipment: centrifuge, three-in-one, plate and frame filter press, positive pressure filter, butterfly centrifuge, tube centrifuge, etc.

Purification equipment: ultrafiltration, nanofiltration, electrodialysis, high pressure preparation column, middle and low pressure chromatography column, etc.

Drying equipment: double cone, rake dryer, square oven, freeze-drying, spray drying;

Automatic sub-packaging equipment and crushing equipment: swing granulator, universal pulverizer, hammer mill, needle crusher, jet mill), 10-20 varieties can be manufactured at the same time.

A strict European and American high-end API cGMP quality system and a high-standard EHS system have been established, with lab-scale (kg scale), pilot and large-scale production abilities. The design capacity is 360 tons/year, ensuring the product quality and providing sustainable and high-quality services.

The advantages of Anhui Poly CDMO

Technical Advantages

Covered technologies include: hydrogenation, halogenation, oxidation, reduction, alkylation, amination, Grignard reaction, coupling, sulfonation and other processes; Core technologies include: biosynthesis (fermentation and enzyme catalysis), fluid chemistry, membrane separation technology, high-efficiency separation and purification technology, micro-pulverization, high-activity closed isolation system, special drying (spray drying and freeze-drying), etc.

Quality System

In the internationalization process, Anhui Poly attaches great importance to the internationalization of the quality system, follows the ICH and cGMP standards, and establishes a quality assurance system that is in line with FDA, ICH, EDQM and other international quality supervision concepts, and the in-house quality specifications of products are all stricter than the quality requirements of national legal standards. Its cGMP system has also been gradually geared to Europe and the United States standards, and it has laid out domestic and foreign registrations. The gadolinium contrast agent workshop has passed an official on-site inspection by the US FDA.

GMP System

The site is built in accordance with the requirements of FDA, EMA, WHO and CFDA (China), and a sound GMP management system has been established. The API production line has passed the CGMP/GMP certification audits performed by US FDA and CFDA.

EHS Management Capacity

Anhui Poly is equipped with an independent safety laboratory with CNAS certification, as well as supporting AC1, ARC, DSC, TGA and other equipment, to conduct comprehensive reaction risk research on chemical processes. A perfect and efficient EHS management system has been established, with the three-level standardization certification and environmental management system certification ISO14001 obtained.

Three Wastes Treatment Capacity

With environmental protection waste gas system, substances with and without halogen are collected and treated by classification. For substances with halogen, the current advanced resin adsorption/desorption process is adopted for treatment and RTO with a treatment capacity of 20,000 cubic meters/hour is provided. The sewage station has a daily wastewater treatment capacity of 1,000 tons/day. More than 20 high-concentration/low-concentration/UASB cells and biochemical cells are in place with a total effective volume of more than 5000 cubic meters. With a compliant CDMO workshop, the rapid transformation of products could be achieved.

R & D Advantages

The synthesis R & D institute and biology R & D institute have been established, with more than 140 R & D personnel, and corresponding quality-research personnel at present; of which more than 50% hold master's degree.

Registration Advantages

Equipped with a professional registration team including members with more than 10-year experience in drug registration in China and overseas countries, Anhui Poly has completed API registration and change applications in China, US, Europe (CEP/ASMF), UK, Canada, Israel, WHO and other markets and has obtained application experiences in Japan, Brazil, South Korea, India, Israel, Saudi Arabia and other markets. The team fully and accurately grasp the different registration requirements of NMPA, FDA, EDQM, EMA and other regulatory authorities around the world for product registration application data, and control from multiple levels and angles such as procedural provisions, regulatory requirements, and technical compliance to ensure the smooth progress of the project.