HUAPONT PHARM is specializing in dermatological drug since her founded in 1994, currently ranked as one of the top three dermatological drug manufacturers in China. With an ambitious extension strategy, 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， neighboring theR&D center. With a total area of58100 m2, it includes production area, warehouse, QA, QC and other buildings.
QUALITY MANAGEMENT
The quality management system ofFDF 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 the facility; nearly half of them are from QC/QA/EHS departments which constitutes a strong quality management system supporting the running of facility.
Equipment:
With the intensive safe and effective requirement forhumanmedicine, the integrated and advanced analytical equipments and production equipments are installed. Moreover, the PMES/ LIMS management systems are introduced into the management of facility.
MANUFACUTRING CAPACITY
With the development of twenty years, seven production lines includingoral solid, oral solution, external preparation, injection and lyophilized are established. The annual 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 |
NEW FACILITY
With the extension of domestic market and overseas market development, the manufacturing capacity and manufacturing environment need to match the higher requirements. HUAPONTPHARMhas started the construction of new FDF manufacturing sitewith a targetto increase the manufacturing capacity and compliance with the GMP of CFDA, FDA, EU and PIC/S.
the overall planning for new FDF manufacturing sitegoing to put in use is that building construction will be completed in end of 2017; production lines and premises will be installed before June 2018; Corresponding inspections such as GMP/EHS will be conducted after then; Eventually the new FDF manufacturing site is planned to put in use in 2019. Allproducts will be transferred to new FDF manufacturing site, and the manufacturing capacity will increase 4~5 times comparing with the current level.
HUAPONT PHARM is specializing in dermatological drug since her founded in 1994, currently ranked as one of the top three dermatological drug manufacturers in China. With an ambitious extension strategy, oncology, tuberculosis and respiratory drugs are included in product list.
LOCATION AND SCALE
The FDF facility is located inZoneB of HUAPONT Pharmaceutical Industry Park， neighboring theR&D center. With a total area of58100 m2, it includesproduction area, warehouse, QA, QC and other buildings.
QUALITY MANAGEMENT
The quality management system ofFDF 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 270employees withqualificationcertificate areworking in the facility; nearly half of them are from QC/QA/EHS departments which constitutes a strongqualitymanagementsystem supporting the running of facility.
Equipment:
With theintensive safe and effective requirement forhumanmedicine, the integrated and advanced analytical equipments and production equipments areinstalled. Moreover, thePMES/ LIMS management systems are introduced into the management of facility.
MANUFACUTRING CAPACITY
With thedevelopment of twenty years,seven production lines includingoral solid, oral solution, external preparation, injection and lyophilized are established. The annual 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 |
NEW FACILITY
With the extension of domestic market and overseas market development, the manufacturing capacity and manufacturing environment need to match the higher requirements. HUAPONTPHARMhas started the construction of new FDF manufacturing sitewith a targetto increase the manufacturing capacity and compliance with the GMP of CFDA, FDA, EU and PIC/S.
the overall planning for new FDF manufacturing sitegoing to put in use is that building construction will be completed in end of 2017; production lines and premises will be installedbefore June 2018;Corresponding inspections such as GMP/EHS will be conducted after then;Eventually the new FDF manufacturing site is planned to put in use in 2019. Allproducts willbetransferred to new FDF manufacturing site, and the manufacturing capacity will increase 4~5 timescomparing with the current level.
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