• Regulatory NewsRegulatory News

    Updated: FDA Warns Banned Indian API Manufacturer Over Filth, Incomplete Complaint Records

    Mumbai-based active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories is quickly turning into the poster child for how to run afoul of nearly every major pharmaceutical regulator. This week, the US Food and Drug Administration (FDA) released its warning letter for the company following an eight-day inspection in March 2015. The three major issues uncovered by FDA included the company’s failure to record or investigate quality-related customer compla...
  • Regulatory NewsRegulatory News

    Indian API Manufacturer Faces Canadian Quarantine Over Data Integrity Issues

    After Slovenian inspectors uncovered serious issues at Indian active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories, Health Canada has issued a voluntary quarantine for all products containing APIs sourced from the company. Background On 18 March 2015, inspectors from Slovenia's drug regulator JAZMP uncovered evidence of serious good manufacturing practice (GMP) deficiencies at Polydrug's facility in Maharashtra, India. In their report, filed to the...