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
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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.
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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.
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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).
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 |
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.
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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