Biocon shares rise over 2% as New Jersey facility receives VAI status on inspection from the US FDA

This comes after its US-based facility received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (US FDA).

In a regulatory filing on Thursday evening, Biocon stated that the status was based on the Current Good Manufacturing Practice (cGMP) inspection conducted by the USFDA at its Biocon Generics Inc. facility, located in Cranbury, New Jersey, between October 6 and 10, 2025.

An EIR is a document issued by the US FDA following the inspection of a facility, which provides details on inspection findings, regulatory compliance, and any observed deficiencies.

According to the US FDA, VAI is an inspection classification that signifies that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. In brief, the issues found during the inspection were minor enough that the FDA deemed that the company would fix them voluntarily.

Other key development

Biocon, on December 15, launched its diabetes and chronic weight management injection, Liraglutide, in the Netherlands through its distribution partner, Pharmamedic BV.

The drug-device combination will be marketed in the Netherlands under the brand names Diavorin for diabetes and Vobexoryn for chronic weight management, the pharmaceutical company said in a regulatory filing.

Liraglutide is a synthetic analog of GLP-1 peptide (glucagon-like peptide-1) that helps lower blood sugar levels and promote weight loss. It is administered as a once-daily injection, the company said.

The launch follows the approval, earlier this year, from the Medicines Evaluation Board (MEB), Netherlands, and will mark the first country in the European Union where the firm will directly launch Liraglutide under its own brand, it added.

Bicon share performance

At around 11:07 am, the stock was trading 1.5% higher at ₹398.15 per equity share.

The scrip has gained more than 3% in the past week but lost nearly 3% over the month. On a year-to-date basis, it has jumped over 8%.

While the share reached a 52-week high of ₹424.95 on November 18, 2025, it touched a year’s low of ₹291 apiece on March 3, 2025.

Biocon has a total market capitalisation of ₹53,278 crore, as of December 19, 2025, according to data on the NSE.