Plan to approach USFDA for re-inspection of key plants in next few months: Lupin

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.

NEW DELHI: Drug major Lupin plans 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.


The Somerset (New Jersey) plant, on the other hand, is currently under the official action indicated (OAI) status, which means the USFDA may withhold approvals of pending applications or supplements from the facility.

"As far as Goa (plant) is concerned, we completed our final update about 3-4 months ago. As we had shared earlier, in March/April, we were going to go back to FDA for a reinspection. There are some additional enhancements that we've been implementing at the site. In the next couple of months, we plan to go back to FDA and be ready for a re-inspection," Lupin Ltd Managing Director Nilesh Gupta said in an analyst call.

Pithampur re-inspection will follow shortly after that, he added.
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Gupta said the company undertook a detailed implementation programme at the facility to come up with required changes.

"I think in the next couple of months, Goa, and very shortly after that, Pithampur would be ready for reinspection. Probably even before Goa, Somerset would be ready for reinspection," he noted.

Gupta said the company wanted to complete further enhancement of systems before approaching the FDA for a re-inspection. The regulatory action by the USFDA has impacted several new approvals, thus affecting the company's business in various regions including the US that remains the single-largest pharmaceutical market globally.

Lupin's Goa plant manufactures oral dosage forms with a capacity of more than nine billion units per annum. It supplies more than 100 products to various regulated markets like the US and the EU.
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Pithampur Unit-2, on the other hand, produces oral formulations and sterile ophthalmics.

The Somerset plant came under the control of Mumbai-based drug firm as part of its acquisition of Gavis Pharmaceuticals in 2015.
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