The US FDA has issued Laurus Labs with an enforcement inspection report (EIR) for its API and drug formulations plants in Atchutapuram, India.
The firm announced its receipt of the report in a Bombay Stock Exchange (BSE) filing on Friday, explaining the facilities in Visakhapatnam - also known as Vizag - were visited by US Food and Drug Administration (FDA) inspectors in May.
Laurus did not disclose the classification of the EIR or respond to a request for more information.
The formulations facility also recently passed an inspection by German State regulatory agency BGV Hamburg according to Laurus.
US FDA OK
Indian API firm ZCL Chemicals Limited says its manufacturing plant in Ankleshwar, Gujarat has passed a US FDA inspection with no Form 483 observations.
The firm – which was previously known as Zandu Chemicals Ltd - announced the plant had successfully passed a fide day audit that began on September 5 in a statement released last week.
ZCL said: “The inspection confirmed the site to be compliant with the principles and guidelines of the FDA’s quality system/current good manufacturing practice regulations for API and no Form 483 observations were issued.”
Continuous manufacturing
Johnson Matthey and Snapdragon Chemistry have teamed up to offer a continuous manufacturing-based API production service.
The accord – terms of which were not provided – is designed to combine Snapdragon’s flow chemistry technologies with JM’s manufacturing knowhow.
According to Johnson Matthey “the two companies have co-located facilities in the Boston area, allowing joint Snapdragon Chemistry and JM teams to interact closely to both develop flow chemistry processes and scale those processes through to manufacturing.”