Lupin plant hit with Form 483 but continues to rack up approvals

The FDA has sent a Form 483 to Lupin listing 6 observations its inspectors made during a visit to one of the company's production plants in central India last month. However, the ticking off has done little to slow the rate of approvals for the facility, which has racked up two site transfer nods and one ANDA go-ahead since receiving the Form 483.

Indore plant--Courtesy of Lupin

Inspectors from the FDA assessed two Lupin facilities on either side of the New Year. The FDA gave a research site in Pune a clean bill of health in November, but found fault with the Indore production plant two months later. Neither Lupin nor the FDA have publicly disclosed the nature of the 6 observations, but events since the inspection suggest the regulator thinks they are unlikely to affect the safety or efficacy of products manufactured at the plant.

Lupin revealed the Form 483 in a press release to publicize the FDA approval of its generic version of a form of Allergan's ($AGN) glaucoma drug Lumigan, which it is manufacturing at the Indore facility. The FDA approval covers bimatoprost ophthalmic solution 0.03%, a dosage that Allergan discontinued in the U.S. at the end of 2012. Allergan attributed the decision the preference of U.S. physicians for the lower dose 0.01% form, which has fewer side effects.

Clearly, Lupin thinks there is still a market for the 0.03% dose at generic prices and the issues at its production plant are yet to hinder its attempt to test this theory. As well as the ANDA, the Indore plant has received clearance for two site transfers since last month's inspection. The lack of disruption from the Form 483 means Lupin remains in the dwindling group of Indian drugmakers that have been relatively unaffected by the FDA's attempts to root out substandard production practices in the country.

- read the release (PDF)
- here's Reuters' take