Products & Services
產品與服務
CRO (R&D, overseas registration)+CMO (production of raw materials, chemical agents and biological agents)+CSO (overseas sales of chemical drugs, traditional Chinese medicine and biological agents)
Founded in 1992 and listed on the GEM in 2017, Poly Pharm has three production bases in Haikou, Hangzhou and Anqing. The company has passed cGMP certification in China, Europe and the US several times, and has the ability to manufacture and internationalize sales from raw materials to formulations, and has obtained marketing approvals for nearly 20 injectable and oral products in Europe, the US and Southeast Asia.Poly also provides CDMO services for domestic and foreign customers, and has built several production lines for raw materials, oral solids, injectables, pre-infusion, eye drops, ointments and oral liquids. At present, we have served many global filing projects for domestic and foreign customers, providing R&D and production support from non-clinical approval to commercialization.
There are three raw material production workshops conforming to Chinese, European and American GMP standards, seven production lines, a total of 150 reactors from 30L to 5000L, and more than 200 other main equipments (drying equipment, centrifuge equipment, vacuum equipment, purification equipment, etc.) in addition to reactors, which can produce more than 10 to 20 varieties at the same time, and the maximum capacity of a single production line can reach more than 100 tons/year. It covers general chemical APIs, contrast agents, anti-tumor products, etc. The core technologies include membrane separation technology, high efficiency separation and purification, micronization, high activity closed isolation system, spray and lyophilization drying technology, etc. The types of reactions involved are hydrogenation, reduction, oxidation, halogenation, alkylation, formatting, sulfonation, acylation, substitution, sulfation, enzyme catalysis, condensation, rearrangement, chelation, etc. The design capacity is 360 tons/year.
Four injection production lines, one of which is an oncology line, have passed cGMP and WHO audits in China, Europe and the United States. Another nine lines are under construction. Both injection and lyophilization can be produced, covering 2ml~100ml celine bottles with different volume dispensing tanks from 50L~1000L, with a total lyophilization area of 300 square meters.
It has passed GMP audits in China and Europe, and is equipped with hot-melt extrusion, fluidized bed side spray and bottom spray equipment, which can produce tablets, micro-pill capsules and granules, of which the annual capacity of tablets is more than 1.5 billion tablets;
Has been granted the GMP manufacturing license in China, with specifications of 10g, 20g, 30g, 50g and an annual capacity of over 20 million sticks;
The workshop is equipped with international advanced German imported linkage production line, which can meet the production of multi-dose 5ml, 10ml, 15ml and other specifications, batch size covers 35L to 1000L scale, annual production capacity of about 600 million sticks
The workshop is designed in accordance with FDA and EU standards, equipped with Bosch linkage line, adapted to 1ml and 5ml specifications, which can meet the scale of 35L to 1000L, with a designed annual capacity of about 600 million sticks;
The workshop is designed in accordance with international standards and is suitable for the preparation of common and complex preparations, suitable for 60ml, 120ml, 300ml and other specifications, equipped with international advanced linkage line, with an annual integrated capacity of about 200 million bottles.
1) Rich dosage forms: tablets, capsules, granules, ointments, eye drops, pre-infusion, injection, lyophilization, oral solution;
(2) Approved quality system in China, the United States and Europe, with the advantage of global reporting, saving R&D clinical costs;
(3) The advantage of one-stop service of the whole industry chain from raw materials to formulations, from small trial to scaling up, clinical, BE, registration, production and international and domestic sales;
(4) domestic and foreign customers for many years CDMO/CMO cooperation experience, experienced and efficient communication;
(5)Polypharm, as a pioneer in the internationalization of domestic pharmaceutical formulations and as a listed company in Hainan, has a good reputation in China.
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