“While this issue affects our production timelines, we expect to produce 6 to 7 million pens in the third and fourth quarters of FY27, apart from the pens already sold,” Chief Executive Officer (CEO) Erez Israeli said in an investor call.
In a regulatory filing on Thursday, the company said that certain batches of semaglutide were found to be out of specification, due to issues associated with the API used in the product.
This particular batch of API was part of its scale-up process to increase semaglutide production. Prima facie, the impurity was related to a reaction-related process in the specific API batch, which could degrade the formulation, Israeli said.
While investigation is still underway to find the root cause and take appropriate measures to ensure product quality, Israeli said that the episode would not have any effects on ongoing operations.
There is no impact on patient safety or on the product's existing global regulatory filings, he added.
However, commercial supplies of the product will be delayed until the issue is resolved and manufacturing processes revalidated.
“We thought we would be able to start production and sell the pens between July and October. While the resolution is expected to be done by September, the actual supply could resume by late October or early November this year,” Israeli said.
DRL has updated all of its customers and licenced partners over the supply delay. “We are committed to resolve this, but if they choose to commit to another partnership, we will respect that,” Israeli said.
The drugmaker expects renegotiations in some of the arrangements for payments for the API supply. “We remain committed to ensuring reliable global supplies of this important metabolic therapy,” it said.
Shares of DRL closed 5.85 per cent lower at ₹1,269.80 apiece on BSE on Thursday.
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