1. Center for Combating Counterfeit Drug
t/ mimic drug founded in Thailand
scarR(Finasteride)
of genuine and counterfeit PROSCAR
mpose of 1 printed letter and come after by 4 number such as
range in vertical line on the bottom of the blister pack.
compose of 2 printed letters, one of them is encircle, and come
alignment of lot number is arrange in vertical line on the
et " PROSCAR" and "MSD" on blister pack
racter of the letter is printed in standing manner. The letter is
k. The quality of printed color is very clear, smooth and better
haracter of the alphabet is printed in inclined manner. It is
ack. The quality of printed color is not clear and blur.
of expiration date on the blister pack is complete, such as: 20
on of expiration date on blister pack is not complete, such as:

2. R FROM MSD TO THAI FDA
D (Australia) received one blister strip of PROSCAR 5mg from
teen tablets of PROSCAR 5mg.
submitted to MMDA from Thai land on 30 th August 2002. A
ot out one blister pack of PROSCAR 5mg from one of the drug
ce is different from current pack distributed in Thailand. It is 15
ket pack. MMDA was requested to inspect the returned blister
materials.
embossed on the returned blister strip is A5278 and is due to
assigned this packaging batch number A5278 to package
arket.
Thailand and Hong Kong were subjected to a laboratory
nt review by MMDA. Attached are the results and summary of
n submitted to Quality Control Laboratory for testing.
finasteride tablets (QS, Revision 12, Method R01- Assay and
ecification Returned Tablets

3. .4 –102.9% of Not detected
bel Claim
23 – 0.77% Not applicable
ed that the returned tablets were less soluble in diluent than
embossed on the returned blister strip is A5278 and is due to
assigned this packaging batch number A5278 to package
arket.
mpared with components from a retention pack of PROSCAR
at MSD Australia.
en use to print the lidding foil on blister strips from the returned
d in blue ink using the same font. Spacing between letters and
ons within the foil-sealing strip were similar between the two
print of the returned sample was not the same to that of the
and expiry date) on each blister strip showed the following
ssed on knurled lidding foil compared to that of the retention
been knurled.
ent.

4. A physical examination of the tablets showed that colour, shape and embossing have the
g differences:
• Colour: MSDA – manufactured tablet is blue, modified apple-shaped. One side
embossed “PROSCAR” and the other side “MSD” above “72”, and with well defined
edges. The returned tablet is more rounded and of greyish blue in colour.
• Font: MDSA – manufactured tablet font is well defined. Noticeable differences in
letter: R, O, S, C, D and A.

5. , we have concluded that the PROSCAR 5mg tablets returned
ot manufactured at MSD Australia but instead are counterfeit