Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL:
Marck Biosciences Ltd. to “Amanta Healthcare Ltd.”, effective from June 24, 2014. Click here to visit website at
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Marck Biosciences Limited is a producer of sterile products which has been producing sterile products for the US market. The FDA Warning Letter dated July 8, 2014 contains shocking details about the GMP situation at this facility. Read more here about the FDA Warning Letter to Marck Biosciences and about the name change to Amanta Healthcare. |
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