US FDA concludes inspection of Lupin’s facility without any observations

Lupin has completed a Good Manufacturing Practice (GMP) inspection as well as a Prior Approval Inspection (PAI) carried out by the US FDA at its Pithampur manufacturing facility – Unit 1 without any observations. The inspection which started on July 24, concluded on July 28.

For the financial year ended March 31, 2017, Lupin’s consolidated sales and net profit stood at Rs 171,198 million ($ 2.55 billion) and Rs 25,575 million ($ 381 million) respectively.

Lupin is developing and delivering a wide range of branded and generic formulations, biotechnology products and APIs globally. The company is a significant player in the cardiovascular, diabetology, asthma, paediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the anti-TB segment.

As per Quintiles IMS’ MAT March 2017 report, the company is the fourth largest pharmaceutical player in the US by prescriptions; the second largest Indian pharmaceutical company by global revenues; the sixth largest generic pharmaceutical player in Japan and the sixth largest company in Indian pharmaceutical market