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Biocon Gets Two US FDA Observations for Visakhapatnam Unit

Synopsis:


Biocon Limited has received two observations from the US FDA for its API Unit (Site 6) in Visakhapatnam, Andhra Pradesh, after a recent inspection. The company confirmed that the issues are procedural in nature and being addressed.


Source:
Biocon Limited Press Release (NSE Exchange Filings) | Published on Nov 08, 2025

Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.

Biocon India News Today

As quoted in the press release from Biocon Limited (NSE Exchange Filings), the United States Food and Drug Administration (US FDA) has issued two observations for its Active Pharmaceutical Ingredient (API) Unit, identified as Site 6, located in Visakhapatnam, Andhra Pradesh.

The inspection was part of the US FDA’s routine oversight of pharmaceutical manufacturing facilities that export to the United States. The Biocon Visakhapatnam unit manufactures a range of APIs that are part of the company’s global supply chain.

Also read: Havells Finalises ₹129.6 Cr Settlement

BIOCON LIMITED.

Trade

383.12.70 (0.70 %)

Updated - 10 November 2025
383.30day high
DAY HIGH
376.35day low
DAY LOW
604535
VOLUME (BSE)

Key Takeaways

  • The US FDA issued two observations for Biocon’s Site 6, Visakhapatnam.

  • The inspection was a routine facility review conducted in early November 2025.

  • The observations were procedural and do not involve product recalls.

  • Biocon stated it will respond to the FDA within the stipulated timeline. 

  • Operations at the site continue without disruption.

Also read: HAL Seals Mega Deal with GE Aerospace

Inspection Overview

The inspection of Biocon’s API facility took place under the US FDA’s regular surveillance process to ensure global compliance with manufacturing practices. The inspection covered production, documentation, and safety protocols.

The two observations recorded by the US FDA were linked to documentation procedures and facility monitoring. The company has stated that it is preparing a comprehensive response and that all manufacturing operations remain compliant with current Good Manufacturing Practices (cGMP).

Observation and Market Data

Particulars

Details

Authority for Inspection

Food and Drug Administration of the United States (US FDA)

Name of Facility

API Unit (Site 6)

Geographical Location

Visakhapatnam, Andhra Pradesh

Total Number of Observations

2

Nature of Observations

Procedural – Documentation related

Status of Operation

Ongoing and Compliant

Last Share Price

₹380.00

Change

-₹5.20 (-1.35%)

Opened

₹384.00

High

₹384.45

Low

₹376.15

Company Overview

Biocon Limited, founded in 1978, is a global biopharmaceutical company headquartered in Bengaluru. The company develops and manufactures biologics, biosimilars, and generic APIs for regulated markets. Its Visakhapatnam site plays a key role in producing ingredients for both domestic and export markets. 

The latest US FDA observations are procedural and part of the regulator’s standard inspection cycle for manufacturing facilities. 

Update on Biocon Share Price

At 15:30 PM IST on November 7, 2025, the Biocon share price was ₹380.00, down 5.20 rupees (1.35%) from the previous close of ₹385.20.  While the market was open, the price of the stock went from ₹384.00 to ₹376.15 and back up to ₹384.45.

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