Lupin is planning to approach the US health regulator for re-inspection of its manufacturing plants in Goa, Pithampur (Madhya Pradesh) and Somerset (US) in the next few months. The company's Unit 2 manufacturing plant in Pithampur, along with its Goa site, is under the US Food and Drug Administration's (USFDA) warning letter since November 2017 for violation of current goods manufacturing practices. The US drug regulator, after inspecting the two sites, had expressed concerns over quality-control procedures that include handling of out-of-specification results and conducting hold-time studies.
On the other hand, the Somerset (New Jersey) plant is currently under the official action indicated (OAI) status, which means the USFDA may withhold approvals of pending applications or supplements from the facility.
Lupin is an innovation led transnational pharmaceutical company headquartered in Mumbai, India.
