VNDA » Topics » Manufacturing

These excerpts taken from the VNDA 10-K filed Apr 29, 2009.
Manufacturing
 
We currently depend and expect to continue to depend on a small number of third-party manufacturers to produce sufficient quantities of our product candidates for use in our clinical studies. We are not obligated to obtain our product candidates from any particular third-party manufacturer and we believe that we would be able to obtain our product candidates from a number of third-party manufacturers at comparable cost.
 
If any of our product candidates are approved for commercial use, we plan to rely on third-party contract manufacturers to produce sufficient quantities for large-scale commercialization. If we do enter into commercial manufacturing arrangements with third parties, these third-party manufacturers will be subject to extensive governmental regulation. Specifically, regulatory authorities in the markets which we intend to serve will require that drugs be manufactured, packaged and labeled in conformity with cGMP or equivalent foreign standards. We intend to engage only those contract manufacturers who have the capability to manufacture drug products in compliance with cGMP and other applicable standards in bulk quantities for commercial use.
 
Manufacturing


 



We currently depend and expect to continue to depend on a small
number of third-party manufacturers to produce sufficient
quantities of our product candidates for use in our clinical
studies. We are not obligated to obtain our product candidates
from any particular third-party manufacturer and we believe that
we would be able to obtain our product candidates from a number
of third-party manufacturers at comparable cost.


 



If any of our product candidates are approved for commercial
use, we plan to rely on third-party contract manufacturers to
produce sufficient quantities for large-scale commercialization.
If we do enter into commercial manufacturing arrangements with
third parties, these third-party manufacturers will be subject
to extensive governmental regulation. Specifically, regulatory
authorities in the markets which we intend to serve will require
that drugs be manufactured, packaged and labeled in conformity
with cGMP or equivalent foreign standards. We intend to engage
only those contract manufacturers who have the capability to
manufacture drug products in compliance with cGMP and other
applicable standards in bulk quantities for commercial use.


 




These excerpts taken from the VNDA 10-K filed Mar 13, 2009.
Manufacturing
 
We currently depend and expect to continue to depend on a small number of third-party manufacturers to produce sufficient quantities of our product candidates for use in our clinical studies. We are not obligated to obtain our product candidates from any particular third-party manufacturer and we believe that we would be able to obtain our product candidates from a number of third-party manufacturers at comparable cost.
 
If any of our product candidates are approved for commercial use, we plan to rely on third-party contract manufacturers to produce sufficient quantities for large-scale commercialization. If we do enter into commercial manufacturing arrangements with third parties, these third-party manufacturers will be subject to extensive governmental regulation. Specifically, regulatory authorities in the markets which we intend to serve will require that drugs be manufactured, packaged and labeled in conformity with cGMP or equivalent foreign standards. We intend to engage only those contract manufacturers who have the capability to manufacture drug products in compliance with cGMP and other applicable standards in bulk quantities for commercial use.
 
Manufacturing


 



We currently depend and expect to continue to depend on a small
number of third-party manufacturers to produce sufficient
quantities of our product candidates for use in our clinical
studies. We are not obligated to obtain our product candidates
from any particular third-party manufacturer and we believe that
we would be able to obtain our product candidates from a number
of third-party manufacturers at comparable cost.


 



If any of our product candidates are approved for commercial
use, we plan to rely on third-party contract manufacturers to
produce sufficient quantities for large-scale commercialization.
If we do enter into commercial manufacturing arrangements with
third parties, these third-party manufacturers will be subject
to extensive governmental regulation. Specifically, regulatory
authorities in the markets which we intend to serve will require
that drugs be manufactured, packaged and labeled in conformity
with cGMP or equivalent foreign standards. We intend to engage
only those contract manufacturers who have the capability to
manufacture drug products in compliance with cGMP and other
applicable standards in bulk quantities for commercial use.


 




These excerpts taken from the VNDA 10-K filed Mar 13, 2008.
Manufacturing
 
We currently depend and expect to continue to depend on a small number of third-party manufacturers to produce sufficient quantities of our product candidates for use in our clinical studies and in preparation of the commercial launch of Fiaptatm. We are not obligated to obtain our product candidates from any particular third-party manufacturer and we believe that we would be able to obtain our product candidates from a number of third-party manufacturers at comparable cost.
 
If any of our product candidates are approved for commercial use, we plan to rely on third-party contract manufacturers to produce sufficient quantities for large-scale commercialization. If we do enter into commercial manufacturing arrangements with third parties, these third-party manufacturers will be subject to extensive governmental regulation. Specifically, regulatory authorities in the markets which we intend to serve will require that drugs be manufactured, packaged and labeled in conformity with cGMP or equivalent foreign standards. We intend to engage only those contract manufacturers who have the capability to manufacture drug products in compliance with cGMP and other applicable standards in bulk quantities for commercial use.
 
Manufacturing


 



We currently depend and expect to continue to depend on a small
number of third-party manufacturers to produce sufficient
quantities of our product candidates for use in our clinical
studies and in preparation of the commercial launch of
Fiaptatm.
We are not obligated to obtain our product candidates from any
particular third-party manufacturer and we believe that we would
be able to obtain our product candidates from a number of
third-party manufacturers at comparable cost.


 



If any of our product candidates are approved for commercial
use, we plan to rely on third-party contract manufacturers to
produce sufficient quantities for large-scale commercialization.
If we do enter into commercial manufacturing arrangements with
third parties, these third-party manufacturers will be subject
to extensive governmental regulation. Specifically, regulatory
authorities in the markets which we intend to serve will require
that drugs be manufactured, packaged and labeled in conformity
with cGMP or equivalent foreign standards. We intend to engage
only those contract manufacturers who have the capability to
manufacture drug products in compliance with cGMP and other
applicable standards in bulk quantities for commercial use.


 




This excerpt taken from the VNDA 10-K filed Mar 16, 2007.
Manufacturing
 
We currently depend and expect to continue to depend on a small number of third-party manufacturers to produce sufficient quantities of our product candidates for use in our clinical studies. We are not obligated to obtain our product candidates from any particular third-party manufacturer and we believe that we would be able to obtain our product candidates from a number of third-party manufacturers at comparable cost.
 
If any of our product candidates are approved for commercial use, we plan to rely on third-party contract manufacturers to produce sufficient quantities for large-scale commercialization. If we do enter into commercial manufacturing arrangements with third parties, these third-party manufacturers will be subject to extensive governmental regulation. Specifically, regulatory authorities in the markets which we intend to serve will require that drugs be manufactured, packaged and labeled in conformity with cGMP or equivalent foreign standards. We intend to engage only those contract manufacturers who have the capability to manufacture drug products in compliance with cGMP and other applicable standards in bulk quantities for commercial use.
 
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