Pan Drugs Limited on FDA Import Alert List
API suppliers should be allowed to make process improvements without having to seek re-approval says consultant Girish Malhotra, who argues that the current rules create inefficiency and waste.
The US Food and Drug Administration has sent a warning letter to Baroda-based Pan Drugs, which had told the regulator that it would divert batches of medicines meant for the US to the Indian market.
Indian API maker Pan Drugs is reconstructing its manufacturing suite after holes in the wall and rusty equipment landed the facility a US FDA warning.
During our July 14-18, 2014, inspection of your pharmaceutical manufacturing facility, Pan Drugs Limited, 167-168, GIDC Nandesari Industrial Estate, Nandesari, Vadodara, India, an investigator from the U.S. Food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs).