GMP: Another Indian API Manufacturer found to be out of GMP Compliance by EU Authorities

India continues to be the place were many manufacturing sites are found to be out of GMP compliance. This time it is the manufacturer POLYDRUG LABORATORIES PVT. LTD. , Plot No. 37, Anand Nagar, M.I.D.C., Ambernath (East), Maharashtra, IN - 421 506, India that is affected. There, EU GMP Inspectors from Slovenia found several GMP compliance violations. In total 17 deficiencies were found and caused the suspension of all CEPs. Manufacturers of medicinal products for the European market who use APIs from Polydrug Laboratories should immediately verify the consequences for their medicinal products as medicinal products containing non GMP compliant APIs can no longer be supplied to EU customers.

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