Glenmark says concerns of FDA addressed

The US market contributes about 30% to Glenmark's consolidated revenue and it expects big growth from here in FY17

Glenmark Pharmaceuticals says it has addressed concerns raised by the US Food and Drug Administration (FDA) in February, following the latter’s inspection of its manufacturing unit at Pithampur, in the Dhar district of Madhya Pradesh, 30 km from Indore.

The US regulator had issued what are termed ‘Form 483 observations’, on deviations from good manufacturing practices. After issue, the company in question must take remedial measures if export from the unit is to be allowed to the US.

Glenmark said on Thursday it had done this. “The Indore (Pithampur) plant was inspected by FDA in February and we received three observations from them, which were responded to in March. Subsequently, we received two product approvals from this plant and we have no outstanding items with the FDA regarding this plant,” it stated.

According to a media report, the FDA observations were on lacunae in control procedures for assuring uniformity and homogenity in tablets, absence of procedures describing warehousing of products and lack of appropriate controls over computers.

The US market contributes about 30 per cent to Glenmark’s consolidated revenue and the company expects big growth from here in FY17. In this financial year, it will launch Zetia, a cholesterol drug, and says it expects substantial growth from this product.