USFDA concludes inspection at Biocon’s Visakhapatnam facility with VIA recommendation

In a filing to the stock exchanges on August 5, the company said that the US health regulator issued the EIR after the conclusion of the inspection at the active pharmaceutical ingredients (API) facility (Site 5) in Visakhapatnam. The biotechnology firm said that the inspection was carried out at the API facility between June 17 and June 21.

After receiving the USFDA report, Biocon said, “Biocon remains committed to the quality, safety, and efficacy of its products.”

On July 27, Biocon told the exchanges that it had received 10 observations from the USFDA after inspection at its subsidiary Biocon Biologics’ facilities in Bengaluru. The inspection was carried out between July 15 and July 26.

This inspection included a current good manufacturing practice (cGMP) review and a pre-licensing inspection (PLI).

The inspection covered six biologics manufacturing units, which comprised four drug substance plants and two drug product plants. Additionally, the inspection extended to five analytical quality control laboratories, four microbiology laboratories, and two warehouses, ensuring a comprehensive assessment of the company's operations.

Following the inspection, the USFDA issued a Form 483 with ten observations, which can be categorised as observations across the four drug substance facilities, seven observations across the two drug product facilities and two observations on the analytical quality control laboratories.

In the fourth quarter of fiscal year 2024, the company reported a 4% year-over-year increase in consolidated operating revenue, reaching ₹3,917 crore. Total revenue grew by 1% year-over-year to ₹3,966 crore.

However, earnings before interest, tax, depreciation, and amortization (EBITDA) fell by 16% to ₹964 crore for the quarter.

Biocon Limited shares opened the session at ₹341.40 per piece on the NSE, up from the previous close of ₹340.40. They gained 2.6% to hit an intraday high of ₹349.40 apiece. However, the stock pared early gains to close at ₹334 apiece, down 1.6%.