CCM Duopharma Biotech Berhad (CCMD), a public listed pharmaceutical company
on the Kuala Lumpur Stock Exchange (Bursa Malaysia) is set to enhance its
position as an innovative player in the pharmaceutical industry when the
region’s first non live cell vaccines fill and finish facility becomes
operational by the third quarter of 2009.
CCM Duopharma Biotech Berhad Chief Executive Officer, Leonard Ariff bin Abdul
Shatar said the 1,000 sq ft fill and finish facility has the ability to
compound, fill, freeze dry, cap, inspect, label and pack non live cell vaccines
to meet the increasing needs of customers who wish to commercialize and launch
their products into the market.
The facility is capable of filling between 1,500 and 2,000 vials per hour.
The fill and finish dosage is administered in sterile liquid form with the fill
volume ranging from 2ml to 20ml.
“As Malaysia’s competency in biotechnology is still in its infancy, it is
logical for us to import vaccines in bulk and package them here. Although it is
a niche area, we are confident that with our experience in small volume
injectables, we can offer our customers comprehensive competency in
manufacturing and filling capabilities on a contract basis,” said Leonard.
“We are confident of tapping into the potential of the human vaccines market
and add value to our customers in the long run and cater to their pharmaceutical
needs,” Leonard added.
Malaysia’s pharmaceutical industry is one of the fastest growing in Asia
Pacific and it has also become increasingly reputable following its ability to
develop high quality products of international standard through the adoption of
Good Manufacturing Practice (GMP) standards of the European Pharmaceutical
Inspection Cooperation Scheme (PIC/s).
Recognizing the growth potential, the Malaysian Government has identified the
local pharmaceutical industry as one of the 12 target growth industries in the
manufacturing sector for further development and promotion in its Third
Industrial Master Plan (IMP3) from 2006 to 2020, which is expected to drive the
industry to a higher level of global competitiveness.
In this regard, Malaysian pharmaceutical manufacturers are encouraged to
undertake higher value-added activities and venture into new growth areas, which
include the human vaccines market.
CCM Duopharma Biotech Berhad (CCMD) is a subsidiary of CCM Berhad, which is
listed on the main board of Bursa Malaysia and is a key player in the
fertilisers, chemicals and pharmaceuticals industries. CCMD was established as a
pharmaceutical trading company in 1979 and was involved in the import and
marketing of pharmaceutical products. It has since become a leading manufacturer
of pharmaceutical products in Malaysia and exports to countries such as Vietnam,
Philippines, Sudan, Papua New Guinea, Pakistan, Bangladesh, Sri Lanka, Republic
of Yemen, Singapore and Hong Kong. Its range of products includes tablets,
capsules, syrup, creams, haemodialysis solution, sterile irrigation solution,
sterile powder injectables, small volume injectables, dental cartridges and eye
drop preparations.
Further information about CCMD can be obtained from our website at
www.duopharma.com.my
CCM Duopharma Biotech Berhad - Fill and Finish Facility
Technical Info-sheet
| |
Description |
Technical Information |
| PRODUCT |
Product
Type |
Inert Vaccine /
Biotech (Recombinant DNA/Protein) Sterile liquid |
| Dosage Form |
Vials (Type 1 Amber or
clear) |
| Packing Fill
Volume |
2 ml to 20 ml
|
| Vial Size |
22 mm diameter |
| FACILITY |
Vial Washing
Room |
Grade
D |
| Compounding
Room |
Grade A/B (A
Environment in B background) |
| Filling
Room |
Grade A/B (A
Environment in B background) |
| Freeze
Dryer |
Grade A/B (A
Environment in B background) |
| Capping Room |
Grade A/C (A Environment in C background) |
| EQUIPMENT |
Washing
Machine |
Bausch and Strobel,
Germany. Model FAW 1005,
Capacity: 1500-2500 units/hour. |
| Compounding
Vessel |
50 Liters to 100
Liters. |
| Filling
Machine |
Rota, Germany, Model:
FLR 50/G
Capacity: 1500-2000 vials / hour. |
| Capping
Machine |
Rota, Germany, Model:
FLR 50/B
Capacity: 1500-2000 vials / hour. |
| Freeze
Dryer |
Telstar, Spain/China,
Model: LYOMEGA 40 ST 2.7/65 TFE
Capacity: 10,000 vials / cycle Vial 16 mm
diameter. |
| Inspection |
Mpack, Germany, Model:
Mpack1136,
Capacity: 2200 vials / hour. |
| Labeling |
Komark, Malaysia, Model: WS100C2LP,
Capacity: 3000 vials /
hour. |
| GMP |
GMP compliance |
European PIC/s (Pharmaceuticals Inspection Cooperation scheme)
WHO
guide Malaysian NPCB (National Pharmaceutical Control Bureau) |
| PROCESS |
Option 1 |
Compounding, Filling,
Freeze Drying, Capping, Inspection, Labeling, Packing. |
| Option 2 |
Inspection, Labeling, Packing |
For further information, please contact Mr. Ibrahim Zainudin (General
Manager, Operations) at tel. +603 3323 2759 ext 1124 or e-mail at
ibrahim-zainudin@duopharma.com.my
ooOoo
Issued by Chemical Company of Malaysia Berhad
For
further information, please contact Mr. Ibrahim Zainudin (General Manager,
Operations) at tel. +603 3323 2759 ext 1124 or e-mail at
ibrahim-zainudin@duopharma.com.my |
