Now, Zydus Cadila gets USFDA warning letter for manufacturing issues

One more major Indian drug company has become a victim of the US Food and Drug Administration's (FDA's) constantly evolving stringent current Good Manufacturing Procedures (cGMP) standards.

The latest is Ahmedabad-based Zydus Cadila. In the past few months, Sun Pharma's two plants and Dr Reddy's three plants had received warning letters from the drug regulator for quality issues. Ranbaxy, now part of Sun Pharma, and Wockhardt are under the FDA scanner for the past few years.

Zydus Cadila Thursday said it has received a warning letter issued by the USFDA relating to its Moraiya formulation facility and Ahmedabad API facility (Zyfine). "We are working hard to ensure that the commitments made to the USFDA are fully completed and will continue to take all necessary steps to ensure that the USFDA is fully satisfied with its remediation of the above facilities," the company said.

Sources said during the second quarter, Zydus had mentioned that it has initiated site transfer of key filings - namely Asacol HD, Toprol XL and Prevacid OTD drugs - and expects this to be done over the next 6-9 months.

"Cadila has already gained site transfer approvals for four of its existing products. Also, its new SEZ formulations facility (oral oncology, oral solids) received the Establishment Inspection Report (EIR) from the USFDA", said Sarabjit Kaur Nagra, analyst with Angel Broking.

The company has undertaken 40-plus filings over the past 3-4 years from this facility, paving the way for monetising its large ANDA pipeline. Additionally, the company is also hopeful of commissioning its new sterile injectable facility located in Baroda by July 2016.

Analysts said it's too early to ascertain the impact on the numbers, as they are awaiting more clarity on the development.