FDA warns Cadila Healthcare about quality of 2 plants

The company's Moraiya and Ahmedabad API plants have come under FDA scanner; company initiates site transfer of key products

Ahmedabad-based Cadila Healthcare has received warning letters from the US Food and Drug Administration about two of its drug manufacturing plants.

FDA has issued warnings about the company's Moraiya plant near Ahmedabad which makes formulations and a bulk drug manufacturing site in Ahmedabad, for violating manufacturing standards.

This is the second time Cadila has received a warning from the FDA about the Moraiya plant. The previous one came in June 2011. The plant was cleared a year later but it returned on to the FDA list last September after an inspection.

The Moraiya plant accounts for nearly 60 per cent of Cadila Healthcare’s $500 million US business in 2014-15 and 40 per cent of pending oral solids filings. Pankaj Patel, chairperson and managing director of Cadila Healthcare, told analysts the company had discontinued production of a narrow therapeutic index drug warfarin, an anticoagulant, following an FDA inspection last September. Narrow therapeutic index drugs are have a thin dividing line between therapeutic and toxic doses.

The FDA had observed deficiencies in the manufacture of warfarin and expressed concerns over Cadila Healthcare’s complaint redressal mechanism. Patel said the company had hired external consultants and revised its standard operating procedures following the inspection.

As for the Ahmedabad plant, Patel maintained it was not supplying any drug to the US either directly or indirectly. The unit was inspected last December.

Patel indicated the company had shifted production of nine drugs from Moraiya to other locations and had initiated transfer of another four. The company expects to file for approvals for these drugs in 2016.

Cadila Healthcare’s plants at Baddi and Ahmedabad SEZ are certified by the FDA, from where the company can continue to export to the US.

The oral oncology and oral solids formulations facility in the SEZ is yet to begin supplies to the US.  The company has undertaken over 40 filings over the past four years from this facility. Cadila Healthcare hopes to commission its new sterile injectable facility in Vadodara by July 2016.

Product approvals by the FDA have slowed down following last year’s inspections and analysts fear the warnings could lead to further delays in Cadila Healthcare’s drug launches.

In August Cadila Healthcare had indicated that it had over 101 approvals in the US. It received final approval from the FDA to market diuretic amiloride hydrochloride tablets in the US in August. The company’s shares crashed 14.89 per cent on the BSE on Thursday ending at Rs 327.8 per share before touching the day’s low of Rs 320.45.