Biocon, one of India’s foremost research-oriented pharmaceutical companies, said the US drug regulator has completed an inspection at its Bangalore facility without remarks.
“The US FDA conducted a periodic cGMP inspection of our Drug Substance manufacturing site at Bangalore Campus from Sep 17 – 21, 2018.
“The week-long audit concluded without any observations and no Form 483 was issued,” it said.
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA.
The standards provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
Biocon manufactures generic active pharmaceutical ingredients (APIs) that are sold in over 120 countries across the globe.
Among its specialties are biologics and biosimilar insulins and antibodies.