product)in Europe and USA, or ciprofloxacine, the active ingredient
worldwide ???
We have started importing ciprofloxacine tablets from MEDEX, UK .
"CIPROFLOXACIN TABLETS USP 250 MG, CIFROTIL (another brand name).
The tablets are produced for MEDEX in India by "Tablets India ltd"...which
is mentioned on the label. The price is affordable (an understatement ?) :
45 USD (FOB) per 1000 tabs
I dont have an USP in our office, and have to presume that the tabs are
described there. I in fact presumed as well that the patent on the substance
ciprofloxacine expired some time back which allows this manufacturer to
produce tablets
The certificate of analysis (on MEDEX headed paper) which came with the
tablets, shows that the batch we received complies to USP specifications
with a shelflife of 3 yrs.
Assuming the certificate can be trusted, I am happy with these relatively
very very cheap tablets because the uniformity of weight and content comply,
the disintegration time and dissolution time comply and the identity and
assay (cmp to ciprofloxacine USP) complies. The difference in price cmp to
IDA is enormous.
These tabs look pretty generic to me and now started wondering how these
came on the market. Is the patent in India off ? and is a UK company allowed
to supply products for which the european or USA patent is still on ? or is
India producing under licence of Bayer ? Is Bayer then responsible for the
quality ? The label in fact mentiones a "Mfg.Licence Number". Maybe someone
can tell us more about that. Is this a licence issued for a specific product
in a specific factory (ie Ciprofloxacin in Tablets ltd, India) and would it
not be a good idea if we (the customers without USP etc, trusting our
suppliers abroad) would be able to check this number with an official agency
like WHO. Or is this a number issued by Indian Authorities ?
If it could be an international licencing code, then using email , one could
very easily check with a central databank (WHO?, MSH? ..) if this licence
number is on the record , and if that specific production is controlled,
allowed etc, for sale on which continents etc.
Also the private sector in Kampala offers Indian ciprofloxacine tablets at
around the same price (on prescription ?, even without , but that is another
problem), it is prescribed/used a lot these days with apparently good results
Together with the Ciprofloxacine tabs we received Flucloxacilline 250mg
capsules form MEDEX, manufactured by Athlone Ireland .These generic capsules
comply to BP standards and are affordable as well, or very cheap cmp to the
Floxapen brand
Same would apply to cefalosporines (Cephalexin only generic available as far
as I know, produced by Biochemie, Austria). the Acyclovir tabs,
Ketoconazole UPS 23 (produced in Italy, Beltapharm)
Captopril, Lisinopril, Fluconazole etc
Who can coordinate the different sources for generics and how can we assure
the quality ?
regards,
Pascal Verhoeven
JMS (Joint Medical Store)
P.O.Box 4501
KAMPALA-UGANDA
tel +256-41-268482 fax + 256-41-267298 Email STOREJMS@IMUL.COM
+256-41-266126
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