CPD: What needs to happen next
To understand what needs to happen next with Caraco getting back in compliance, let’s look at what Sun Pharma management said in the recent conference call.
Dilip Shanghvi: I think Caraco needs to share the specific timeline, which they have not shared. I can only explain the process, explaining the timeline. The process is that Caraco has to decide whichever product it wants to revalidate and take the revalidation batches in presence of the CGMP experts, and once the experts are satisfied, a separate team of these experts is satisfied that the facility is in compliance, then they have to inform the FDA that they can come for inspection. We expect that FDA will come for inspection after this is communicated, and if the product and the facility are found to be compliant after the FDA audit then these two products will be permitted, so this will be a product-by product re-certification process.
So we could see CPD restart manufacturing of drugs sooner than expected. I think the company will likely ask for 1-2 products that they want to re-validate initially. This will increase the company’s top line, cash flow, and put the rehired employees to work. The company will slowly add additional products into compliance. For current CPD holders, I highly recommend reading Sun Pharma’s recent conference call transcript.