Regulatory Guidance

Glenmark receives FDA warning letter for Baddi plant

Oct 07, 2019

Mumbai-based Glenmark Pharmaceuticals has been issued an FDA warning letter for manufacturing issues at its Baddi plant.

The company addressed the warning letter in a public filing saying that the warning came after an inspection that initially triggered a From 483. The company did not disclose exactly what the FDA took issue with, but when the FDA issued a Form 483 to the facility in 2017, it mentioned that the agency had received complaints about a cream produced at the plant that was watery. The agency ultimately found that the product had been stored in temperatures as high as 112 degrees F for up to 30 hours.

Glenmark said it is working with the agency to “implement corrective actions.”

Glenmark, which specializes in OSD, liquids, and topical skin treatments, has eight manufacturing plants in India approved by the FDA. The company said that its Baddi facility is the only plant that has run into trouble with the agency.

The company also disclosed that it the plant will contribute about $30 million in sales this year — but that it does not expect to take a financial hit from the regulatory action.

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