Biocon Limited has announced the successful completion of a U.S. Food and Drug Administration (FDA) Pre-License Inspection at its biosimilars manufacturing site located at Biocon Park in Bengaluru, India. The regulatory inspection represents a significant milestone in the company's ongoing efforts to meet international quality standards for its biosimilar products.

Official Company Statement

Biocon filed an official statement with BSE Limited and National Stock Exchange of India Limited on April 30, 2026, confirming the completion of the FDA inspection. The company's filing, signed by Company Secretary and Compliance Officer Rajesh U. Shanoy, provided comprehensive details about the regulatory review process.

Inspection Details and Scope

The comprehensive FDA inspection was conducted over a ten-day period from April 20, 2026, to April 29, 2026. The regulatory review covered multiple critical areas of Biocon's manufacturing operations, demonstrating the thoroughness of the FDA's assessment process.

FDA Form 483 Observations

At the conclusion of the inspection, the U.S. FDA issued a Form 483 containing five observations. The company has emphasized that these findings are procedural in nature and do not pertain to critical areas such as data integrity or quality oversight systems. Notably, there were no repeat observations from previous inspections, indicating progress in maintaining compliance standards.

Company Response and Commitment

Biocon has committed to addressing the FDA observations through a structured approach. The company plans to submit a comprehensive Corrective and Preventive Action (CAPA) plan within the FDA's stipulated timeline. Management has expressed confidence in their ability to address all observations fully and expeditiously.

According to the company spokesperson, "Biocon remains committed to upholding the highest standards of Quality and Compliance and working collaboratively with global regulatory agencies to ensure the safety, efficacy, and reliability of its products."

Regulatory Significance

The completion of the Pre-License Inspection represents an important step in Biocon's regulatory approval process for its biosimilar products in the U.S. market. The procedural nature of the observations and absence of repeat findings suggest that the company's quality systems are generally aligned with FDA expectations, requiring only specific procedural adjustments to achieve full compliance.

Biocon Limited has published newspaper advertisements on April 28, 2026, as part of the Second 100 Days Campaign 'Saksham Niveshak' launched by the Investor Education and Protection Fund Authority (IEPF), Ministry of Corporate Affairs, Government of India. The company has submitted copies of these advertisements to stock exchanges under regulatory compliance requirements.

Campaign Background and Objective

The Second 100 Days Campaign 'Saksham Niveshak' is a continuation of an earlier initiative launched by the IEPF Authority through its circular dated July 16, 2025. The campaign requests companies to reach out to shareholders whose dividends remain unpaid/unclaimed before they get transferred to the Investor Education and Protection Fund.

Regulatory Compliance and Publication Details

Biocon Limited has fulfilled its regulatory obligations by publishing the advertisements and notifying the stock exchanges. The company submitted the advertisement copies to both BSE Limited and National Stock Exchange of India Limited pursuant to Regulation 30 and 47 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Shareholder Action Requirements

The advertisements outline specific actions required from shareholders to claim their unpaid/unclaimed dividends:

For shareholders holding shares in physical mode:

• As prescribed by SEBI, effective April 01, 2024, shareholders with physical shares and outdated KYC details are eligible for dividend only in electronic mode
• Required details include: PAN, Contact Details, and Signature
• Shareholders must submit Investor Service Request (ISR) Forms ISR-1 and ISR-2 to the company's Registrar and Transfer Agent

For shareholders holding shares in demat form:

• Shareholders can claim dividends by updating bank details with their respective Depository Participants
• Updates will automatically appear in the company's subsequent records

Contact Information and Support

Shareholders requiring assistance can contact the company or its Registrar and Transfer Agent. The company has provided comprehensive contact details for shareholders to update their information and claim unpaid dividends.

The information and detailed guidelines are also available on the company's website at www.biocon.com for shareholder reference and action.