A day after Wockhardt said that the recent USFDA’s follow-up inspection was to assess the progress made in areas of good manufacturing practices remediation and robust quality management, founder chairman and group CEO Habil Khorakiwala told FE’s Neha Bothra that the US drug regulator found the company’s quality and manufacturing system satisfactory. However, it has put forth certain observations on Form 483 pertaining to review of products manufactured before implementation of the GMP remediation programme. Excerpts:

What is the update on inspection carried out by the USFDA at the Chikalthana plant?
I think in the 10-day intensive inspection they found our quality system and manufacturing system satisfactory. However, they want a proper review of the products manufactured previous to their last visit. They have given Form 483 to us with a number of observations. We are in a process to remedy the situation and we will communicate our future line of action to them within 15 days. I think it is a forward movement, as far as we see it. We clearly know the additional requirement of the regulators and our team believes that we should be able to respond to all their queries in the next few months.

How long would it take for the USFDA to notify a final decision?
The way the regulator operates is that till all issues are completely resolved they do not consider intermediate decision in the process. We believe that it is a process we are going through. I cannot guess how much time this process will take.

What are the sales generated from the Chikalthana plant post the import alert imposed by the USFDA?
The Chikalthana facility is in compliance with the UK regulator. We have started manufacturing products and will supply to markets in the UK. As far as sales to the US market is concerned, we continue to supply from our B15 Waluj facility since that is not under the import alert. But the volume of that business is relatively small.

The Chikalthana plant contributed around $250 million to sales before the import alert. To what extent do you hope to recover sales from this plant once the import alert is revoked?
It may not happen immediately, but over a period of time, we should be able to recover between 50-60% of our sales from this plant.

Any update on the Shendra unit?
We have offered an inspection to the USFDA. In the last one month they have visited two of our manufacturing facilities — Waluj and Chikalthana. We believe in a reasonably short period of time they will come and visit the rest of our facilities too. We also expect to continue supplies from the Shendra facility, once it is inspected and approved.

How does the drug pipeline look?
This year, we have 17 or 18 new filings. Our R&D programme is on normal course. Once we get our existing facility in compliance, we will be able to resume manufacturing of products approved earlier, and we will start receiving approvals for new drug applications that we have filed. Most of our new filings are from the Shendra plant.