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Dr.
Walter Bartoli and his wife Ida started to produce the first
bile acids in a basic laboratory and in 1949 they founded
Industria Chimica Emiliana (ICE).
From the production of Cholic acid they developed through
modern technology, bovine and swine bile derivatives becoming
one of the most important world producers. The primary raw
material consists of ox-bile. The company has established
a worldwide network, which controls the collection of ox-bile
from the main producing countries. In 1996 the company B.B.A.
was established in Brazil with its primary function being
the collection of bile from the main Brazilian slaughterhouses.
The Brazilian plant produces raw Cholic acid, which is totally
exported to Italy for its necessary purification. Cholic acid
is the starting material for all other pharmaceutical derivatives.
At the end of 1999 I C E acquired Roth Products of Texas (R.P.T.)
a major company with 50 years experience in this field. R.P.T.
collects 50% of the available ox-bile in the U.S., which is
sent to Brazil for its processing. An increase in demand of
bile has induced I C E to expand its collection thus creating
a worldwide supply network. Currently, the main bile-supplying
Countries include Argentina, Brazil, Columbia, Costa Rica,
India, Paraguay, Uruguay, U.S.A. and Venezuela. The suppliers
are both slaughterhouses and
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concentrators
of ox-bile. In Argentina, Columbia, Paraguay and Uruguay exclusive
concentrators work only for ICE. The quality of the product
is ensured via an initial selection of the raw material. All
ICE’s suppliers are subjected to an auditing system that monitors
and maintains the high quality that is demanded for its product.
ICE's efficient organisation has established a traceability
system which enables the product to be traced at all stages
of its processing, from the final product to the slaughterhouse.
At the end of 2000, given the increasing concerns regarding
the B.S.E. crisis, ICE has requested E.D.Q.M. the Certificate
of Suitability to European Pharmacopoeia (CPMP/BWP/1230/98
rev.01, Note for Guidance on minimizing the risk of Transmitting
animal Spongiform Encephalopathy agents via medicinal products)
for its key-products i.e. Cholic acid, and Deoxycholic acid.
The issued Certificates (R0-CEP 2000-334 Rev 00 and R0-CEP
2000-335 Rev 00) cover all the products derived from Cholic
and Deoxycholic acid and guarantee the end-user the necessary
health and safety standard of the starting material.
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