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Time of issue:2019-09-22 00:00:00

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HUAPONT PHARM

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FDF plant

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FDF plant

Categories:About Us
Time of issue:2019-09-23 00:00:00
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Description:

Information

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.

Location and scale

The FDF facility is located in Zone B of HUAPONT Pharmaceutical Industry Park and to be the neighbor of R&D center. The FDF facility covers 58100 m2 which includes the production areas, warehouse, QA, QC and other buildings.

Quality management

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.

Personnel and equipment

Personnel: More than 270 professional employees with qualification certificate are working in 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. For analytical equipment, general analytical equipment like HPLC, GC, IR, UV and more advanced and large precise analytical equipment like ICP, GC/MS, LC/MS, XPRD, AAS are equipped. Lab CDS system is applied on analytical equipment to guarantee data reliability. For production equipment, SCADA system is applied for collecting and recording process parameters and it also protects data reliability.

Manufacutring capacity

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)
Tablet	900	Tablet
Capsule	300	Capsule
Injection	30	Bottle/Bag
Solution	25	Bottle
Cream/ Ointment/ Gel/ Lotion	60	Tube
Suspension/ Spray	10	Bottle/Bag

Technical advantages

HUAPONT PHARM has strong research ability and longer history on retinoids and vitamin D, and has great advantage on microcrystallization of insoluble drugs and drugs for external use. 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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