Wockhardt's Chikalthana plant under USFDA scanner

Wockhardt's Chikalthana plant in Aurangabad is under US Food and Drugs Administration (USFDA) scanner, reports CNBC-TV18’s Archana Shukla. It is the company’s second plant that has come under the USFDA scanner.

Chikalthana plant in Aurangabad was jointly inspected by USFDA and the regulator from UK Medicines and Healthcare products Regulatory Agency (MHRA) in July. The company has confirmed that the regulators have raised certain observations. USFDA has issued Form 483 with their observations and the company does admit that some of these observations are serious in nature. It will respond by next week to these deficiencies and what it is doing to improve conditions.

Also Read: Wockhardt Q1 net down 15% to Rs 323 cr, sales slightly up

Chikalthana is a key plant for US supplies and it supplies some of the key brands like Toprol XL for Wockhardt. It did sales of about USD 230 million last year. Also, it is quite a key plant now that the Cephalosporin plant in Waluj is under an import alert by the USFDA and UK regulators.

In case these observations are serious in nature and the company is able to respond well and within the expectations of the USFDA things may get back on track, but if it fails to do that then it might result in a similar warning letter as in case of Waluj facility. The company's Shendra plant, which is a new plant in Aurangabad, was also inspected by the two regulators. However, nothing significant was observed there.