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Posted 03 February 2015 | By Alexander Gaffney, RAC

India's Data Integrity Problems


In recent months, the US Food and Drug Administration (FDA) has identified more than a dozen Indian pharmaceutical manufacturers who have had problems with the data integrity practices at their respective facilities.

Those data are intended to ensure that products meet pre-established specifications, such as for purity, potency, stability and sterility. In the absence of credible data, the concern is that these products cannot be trusted. And indeed, FDA has subject many of these same companies to import alerts, refusing their products entry into the US.

For a look at the Warning Letters FDA has sent to Indian pharmaceutical manufacturers about data integrity programs, check out the chart below:

Last updated on 3 February 2015

Warning Letter Issued To Date Warning Letter Issued In Focus
Apotex Research Private Limited 01/30/2015 Here
Micro Labs Limited 01/09/2015 Here
Cadila Pharmaceuticals Limited 10/15/2014 Here
Marck Biosciences Ltd. 07/08/2014 Here
Apotex Pharmachem India Pvt Ltd. 06/17/2014 Here
Sun Pharmaceutical Industries 05/07/2014 Here
Canton Laboratories Private Limited 02/27/2014 Here
USV Limited 02/06/2014 Here
Wockhardt Limited 11/25/2013 Here
Agila Specialties Private Limited 09/09/2013  
Posh Chemicals Private Limited 08/02/2013 Here
Aarti Drugs Limited 07/30/2013  
Wockhardt Limited 07/18/2013 Here
Fresenius Kabi Oncology Ltd 07/01/2013 Here
RPG Life Sciences Limited 05/28/2013 Here


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