- Categories:About Us
- Time of issue:2019-09-23 00:00:00
HUAPONT PHARM is specializing the dermatological drug since founded in 1994, currently ranks top three dermatological drug manufacturers in China. The dose forms encompass tablet, capsule, cream, ointment, injection and suspension; furthermore with the drug products extension strategy, the oncology, tuberculosis and respiratory drugs are included in product list.
Innovation, passion and diligence, are the characteristics of the R&D of HUAPONT PHARM; it is the strong support for the company going forward. Talents and technology are the core value of HUAPONT PHARM.
Relying on science and technology;Devoting to human health. As mission, HUAPONT PHARM emphasizes research and development ability since 1992, the beginning of foundation; more than 10% of profit every year is invested in R&D center. With decades of rapid developing, a multifunctional and advanced R&D center which meets the requirement of development of modern pharmaceutical company is playing an important role in HUAPONT PHARM.
Location and scale
The R&D centerFDF facility is located in Zone B of HUAPONT Pharmaceutical Industry Park and to be the neighbor of R&D center. The FDF facility is covered 58100 m2 which includes the production areas, warehouse, QA, QC and other buildings.
in the Headquarter of HUAPONT PHARM where stands at the foot of green hill (Zhaomu Mountain) and surrounded by the Botanical garden of Zhaomu Mountain. The center covers 30000m2 including Synthesis labs, Analysis labs, Dosage form labs, Toxicology labs, Pharmacology labs, pilot plants for API and dosage form, and other labs.
The quality management system of FDF facility is set up based on EU GMP and FDA cGMP, which aims at strictly in-process control so as to ensure products quality, patients’ safety and drug efficacy.
According to the purpose of developing and researching APIs and drugs, and refer to relative regulations, an integrated and reasonable system is established. The R&D center is divided into seven parts:
Science and technology committee
Quality Assurance Department
Research Management Department
Personnel and equipment
Personnel: More than 100 270 professional employees with qualification certificate are with high education are working in R&D center. 10% of them are Ph.D. degree, 30% of them have the medium-grade or high grade professional tile, and 20% of them have obtained the qualification of licensed pharmacist. facility; nearly half of them are from QC/QA/EHS departments. The stronger Quality Management System support the running of facility.
Equipment: with the deeply safe and effective requirement for medicine, the complete and advanced analytical equipment and production equipment are equipped. Moreover, the PMES/ LIMS management systems are introduced into the management of facility. Own the general analytical equipment like HPLC, GC, IR, UV, also more advanced and large precise analytical equipment, ICP, GC/MS, LC/MS, XPRD, AAS, etc. are introduced and applied for solving difficulties in research of APIs or drugs.
With the development of twenty years, seven production lines including oral solid, topical Preparation, lyophilized and sterile Preparation are established. The manual manufacturing capacity is described as below:
|Dosage Forms||Capacity (Million unit/year)|
|Cream/ Ointment/ Gel/ Lotion||60||Tube|
HUAPONT PHARM has the strong research ability and longer history on retinoids and vitamin D; and the microcrystallization of insoluble drugs and drugs for external use have great advantage. Moreover R&D center corporate deeply with institutes or universities to develop new projects and set up research center, for example the high effective drug research center together with Chongqing University.
Achievement new Facility-Comply with GMP of CFDA, US-FDA, EU and PIC/S.
With the extension of domestic market and overseas market development, the manufacturing capacity and manufacturing environment need to match the higher requirements. HUAPONT PHARM has started the construction of new FDF manufacturing site which target is to increase the manufacturing capacity and compliance with the GMP of CFDA, FDA, EU and PIC/S. Every year at least 15 new projects are running.
Up to now the R&D center has made many great achievements.
75+ production licenses by China-FDA and 10 DMF approval by overseas Authorities
85+ patents are authorized including 3 innovative compounds (new chemical entities, NCEs), and some of them are in development stage for toxicology and/or pharmacology.
Full experiences of cooperating with pharmaceutical partners by CMO for NDA and Paragraph IV application
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