Wockhardt Expects To Resolve Five-Year-Old U.S. Ban On Facility Soon
Wockhardt is in final stages to resolve U.S. FDA’s import alert for one of the three plants that can’t export drugs to U.S.
Wockhardt Ltd. said it’s in final stages to resolve the U.S. drug regulator’s import alert for one of the three plants that can’t export drugs to the American market because of lack of good manufacturing standards.
The company is in the last lap of remedial efforts for Waluj, Maharashtra facility, Murtaza Khorakiwala, managing director at Wockhardt, told BloombergQuint in an interview. The corrective steps that include changing processes and employees were almost complete, he said, and the company will be able to invite the U.S. Food and Drug Administration for a re-inspection in a couple of months.
The plant was barred from exporting drugs to U.S. in 2013. The same year, the regulator issued an import alert to its another facility in Chikalthana, Maharashtra, and followed that up with similar action against Wockhardt’s third facility in Ankleshwar, Gujarat in 2016.
The contribution of the U.S. market to Wockhard’s sales has fallen from about 50 percent to nearly 17 percent now since it ran into regulatory troubles, according to Bloomberg data. As a result, shares of the drugmaker have tumbled nearly 75 percent from their all-time peak. It has about 70 drug filings pending with the U.S. FDA.
Khorakiwala said the company is looking at resolving the issues in phases, starting with Waluj. The remedial steps for Chikalthana and Ankleshwar plants will start only after Waluj gets clearance, he said.
Other key highlights from the interview
On Pharmaceutical Industry
- The Indian pharma industry has moved beyond the impact of GST and demonetisation.
- The global market is becoming more competitive and price conscious.
On New Chemical Entity Drugs
- The company is betting on the new chemical entity pipeline.
- Drugs under clinical trials which will be launched soon.
- One drug has completed phase 3 trials in India which will be launched next year.
- Two other drugs will start global clinical trials soon.
On U.S. FDA Resolution For Plants
- Have invested in remedial aspects of plants over past the few years.
- In discussion with the regulator to answer their queries on plants.
On Selling Business
- Cannot comment on any possible mergers and acquisitions.
- Not looking to sell India business—it will the growth engine of the company.