Cadila's Moraiya facility under US FDA lens

Sources say FDA letter over product and not entire facility

Drug maker Cadila Healthcare has come under the US regulatory scanner with US Food and Drug Administration (US FDA) raising concerns about at least one product, for which the company has sought approval from the regulator, it is learnt.

The American regulator has issued an FDA Form 483 to Cadila Health’s Moraiya facility in Gujarat with observations and seeking details related to Abbreviated New Drug Applications (ANDA) filed by the company in the US. When contacted, the company clarified that the FDA has not expressed concerns for its current operations at its Moraiya plant.

“This was a product-specific review and the inspection was limited to the review of documents for filed ANDA before its approval and the observations are being responded to. There are no good manufacturing practices (GMP)-related issues and as such, no business impact,” said a Cadila spokesperson. She added that the US FDA conducted the GMP-related audit at the company’s manufacturing plant in Moraiya in August 2013 and it was cleared.

Form 483, issued to a company by US FDA authorities, usually highlights deviations found during inspection, included lack of written procedures and process controls in the plant, lack of records, absence of training for employees etc. Once the Form 483 is sent, the company has 15 days to respond before the FDA takes any further action.

Industry analysts say Form 483 currently does not indicate any major impact on the company’s present business. However, if Cadila Health fails to address the regulator’s queries and concerns adequately within the specified time period, it might attract significant action including a warning letter or even a halt on further approvals or supplies from the plant.

Even products related queries by US FDA may lead to halting further approval of products, depending on what response US FDA gets from the company, brokerage Sharekhan said in a note.

In the past few years, domestic manufacturing facilities of many major Indian pharmaceutical companies including Sun Pharma, Wockhardt and Ranbaxy Laboratories have come under the US FDA scanner for violating manufacturing norms. The regulator has also barred various plants from supplying medicines to the American market.

US FDA has also indicated that it intends to increase presence as well as operation in India to ensure patients in the US receive quality and efficacious medicines.

On Thursday, shares of Cadila Healthcare ended at Rs 1,118.55 on the Bombay Stock Exchange, down 4.02 per cent. It touched a low of Rs 1,048 during the day.