Natco Pharma lines up product filings; greenfield formulations facility coming up in Vizag.

Natco Pharma has lined up a few product filings in the current financial year.

According to its Vice Chairman & Chief Executive Officer Rajeev Nannapaneni, Natco has a target for six or seven products filings this year. “We are not disclosing numbers exactly, but we are on track,’’ he said, while responding to queries in an earnings call.

Natco’s ability to file Abbreviated New Drug Applications (ANDAs) will be boosted after the completion of its facility in Vizag which should be ready by March 2017. The greenfield formulations facility is coming up in the pharma city with an investment of ₹120 crore.

“Once the new site comes in, I think, we should be able to do more than 10 filings a year,’’ the CEO said, while adding that it will be the target for the next financial year. The Hyderabad-based company has filed three products so far in the present year.

Natco is expecting approval for Revlimid from the US FDA early next year as it is in the processing of replying to a query it received in this connection.

It is also positive on obtaining approval for Copaxone.

The company is expanding its US footprint through differentiated product pipeline of niche and complex products. It has 38 ANDA filings including 16 Para IV filings as on March 31, 2016, targetting a combined market of over $16.3 billion.

Out of this, it has 16 approved ANDAs, including three tentative approvals.

Some of the key filings include key brands such as Copaxone (multiple sclerosis), Gleevac (cancer) and Revlimid (multiple myloma).

Currently, Natco is engaged in discovery and development of two key molecules related to treatment of brain tumor, pancreatic cancer and breast cancer which are in clinical phase studies.

HBL