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昵称至少6个字符,最多18个字符
昵称至少6个字符,最多18个字符
昵称至少6个字符,最多18个字符
昵称至少6个字符,最多18个字符

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 plant is located in Zone B of HUAPONT Pharmaceutical Industry Park and to be the neighbor of R&D center. The FDF plant is covered 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 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. Moreover, the PMES/ LIMS management systems are introduced into the management of facility. 


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 FormsCapacity (Million unit/year)
Tablet900Tablet
Capsule300Capsule
Injection30Bottle/Bag
Solution25Bottle
Cream/ Ointment/ Gel/ Lotion60Tube
Suspension/ Spray10Bottle/Bag

NEW FACILITY

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.                                                         

the overall planning for new FDF manufacturing site coming into use is that building construction will be completed in end of 2017; production lines and premises will be installed till June 2018; according inspections, GMP/EHS, will be conducted after then; finally the new FDF manufacturing site is planning to put in use in 2019. All dose forms will transfer to new FDF manufacturing site, and the manufacturing capacity will increase 4~5 times of current level.

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