After the FDA clamped down on its facilities most of the year, Lupin has received clearance from the agency to produce drugs again at its site in Goa, India.
The Goa facility, which manufactures a range of finished products including oral solids and injectables, account for more than 30 percent of Lupin’s U.S. sales. Upon reporting the news, Lupin saw its stock rise eight percent erasing its entire previous weeks’ losses.
The battles between the FDA and Lupin include the agency citing the Goa facility after discovering nine observations including three involving facility and equipment systems; three related to the production system; and individual citations for the laboratory control system, quality system, and materials system.
In March, Lupin’s Mandideep production facility received a 483 letter after an inspection in February.
The FDA adopted ICH Q10 for good reason: The lifecycle approach to drug GMP promises to improve quality across the board. A Process Approach to Pharmaceutical Quality Systems walks you step by step through the processes and procedures you’ll need to put in place.