Loading...

BIOCON Biocon Ltd US FDA Inspection Announcement

Bcn

BCN

Biocon Ltd

(BIOCON)

2025 Announcement

Summary

Summary

Subsidiary Name Changes

Health Canada Approval

Insulin Partnership Expansion

Compliance Certificate

US Facility Update

Investor Meeting

Trust Amendment

FDA Approval Received

U.S. Market Entry

Show Cause Notice

Commercial Paper Buyback

Record Date Buyback

Shareholder Letters

School Construction Support

U.S. Facility Inauguration

Shareholder Communication

Management Change

Investor Meet Scheduled

Investor Meeting

FDA Inspection Complete

Investor Meet Info

Investor Meet Scheduled

FDA Approval Granted

Newspaper Publication

Earnings Call Transcript

Investor Meetings

Financial Results

Chairperson's AGM Speech

Management Change

Earnings Call Recording

Monitoring Agency Report

Stake Acquisition

Acquisition Announced

Q1 Financial Results

Oral Cancer Initiative

New Appointment

Newspaper Publication

FDA Approval Granted

Compliance Certification

CFO Certification

Management Change

Management Change

Earnings Conference Call

Biosimilar Approval

AGM Announcement

Biosimilars Approved

Insulin Supply Update

Yesafili Launch

OCD Acquisition

Final Dividend Announcement

Partnership for Patients

Equity Fundraise

Equity Shares Allotted

Qualified Placement Approval

Credit Rating Reaffirmed

Equity Shares Placement

Financial Statements Approved

BioWISE Program Launch

Diabetes Drug Approval

KYC Update Reminder

UK Approval Granted

Contract Extension

Biosimilar Launch

Earnings Call Transcript

FDA Approval Granted

Newspaper Publication

Unclaimed Dividends Alert

Secretarial Compliance

Investor Presentation

Financial Results Published

Earnings Call Recording

Investor Presentation

Q4 FY25 Results

Postal Ballot Notice

Yesintek Market Access

Record Date Announced

Commercial Paper Redemption

Positive CHMP Opinion

Commercial Papers Issued

Credit Rating Update

Yesafili Launch

Compliance Certificate

FDA Approval Received

SEBI Compliance Cert.

Earnings Conference Call

Disclosure Delay

Dividend Reminder

Positive Study Results

Insulin Access Expansion

Investor Meeting

Graduation Celebration

20 Years Anniversary

Postal Ballot Notice

Regulatory Order

Biosimilar Launch

Biosimilar Approval

Record Date Intimation

Public Art Project

Investor Meet Scheduled

Investor Meeting

Earnings Call Transcript

Positive Study Results

Corporate Presentation

Financial Results Update

Penalty Notification

Biocon Acquisition Completed

Q3 FY25 Earnings Call

Amendment Approved

Management Change

Equity Acquisition

Commercial Paper Issue

Investor Meetings

ESG Score Update

Credit Rating Update

FDA Classification VAI

Investor Conference

Regulation Compliance

Investor Meeting

Anniversary Celebration

Product Approval

Earnings Call Scheduled

New Product Approval

Acquisition Completion

FDA Inspection Result

EU Approval Granted

Investor Meeting

Investor Meeting

Approval Recommendation

Award Recognition

Investor Meeting

Asia IP Elite Award

Share Sale Announcement

FDA Inspection Update

FDA Approval Granted

Founders Day Celebration

Investor Meeting

Diabetes Care Initiative

Investor Meetings

Investor Meeting

Credit Rating Reaffirmed

Investor Meeting

Investor Meeting

Investor Meeting

Investor Meeting

Placement Success

FDA Classification Update

Q2 FY25 Earnings

Investor Meet Scheduled

Investor Meeting

Financial Results Published

Earnings Call Recording

Q2 FY25 Earnings

FDA Facility Classification

Top Employer Ranking

Biocon Awarded Honor

Regulatory Compliance

Fundraising Announcement

Biosimilar Adoption Boost

Debt Refinancing

FDA Inspection Results

FDA Inspection Update

Partnership Announcement

Dermatology Data Presentation

Senior Notes Offering

Investor Meeting

Corporate Presentation Anno...

FDA Inspection Update

Investor Meeting

Investor Meeting

Investor Meeting

Investor Meeting

Investor Meeting

Lost Share Certificates

Investor Meeting

GST Penalty Ordered

Credit Rating Update

FDA Approval Received

FDA Approval Received

Investor Meeting

Biosimilar Market Entry

Regulatory Penalty

Postal Ballot Notice

Share Certificate Update

Investor Meeting

Q1 FY25 Earnings Call

Corporate Presentation

Investor Meetings

Financial Results

Director Appointments

Financial Results Announcement

Inspection Completion

Director Cessation

Reminder Letter

Newspaper Advertisement

Certificate Submission

AGM Advertisement

Meeting Conducted

Dividend Tax Deduction

Meeting Conducted

Investor Presentation Release

Meeting Conducted

Company Statement

Meeting Conducted

GST Penalty Intimation

Meeting Conducted

Share Certificates Lost

Meeting Conducted

Investor Conference

CFO Appointment

Institutional Meeting

Investor Meeting

Regulatory Action

Meeting Conducted

Investor Conference

Meeting Schedule

Licensing and Supply Deal

Compliance Report Submission

Published Reminder Letter

Reminder for Unclaimed Divi...

Meeting Conducted

Biocon Biologics FDA Approval

Financial Results Publication

Financial Results Announcement

Board Meeting Outcomes

Tax Penalty Announcement

Tax Penalty Notices

Compliance Certificate

Compliance Certificate

Merger of Equals

Meeting with Investors/Anal...

Approval in South Africa

Licensing Agreement

Meeting with Investors

Certificate Submission

Board Meeting and Conferenc...

Meeting Conducted

Meeting with Investors

Business Transfer Completed

Approval for Diabetes Drug

Meeting Conducted

Newspaper Publication

Regulatory Compliance

Meeting with Investors

Resignation Announcement

CFO Resignation

Business Transfer to Eris L...

Appointment Announcement

Biocon Biologics Canada Mar...

Biocon Biologics Agreement

FDA Inspection Announcement

Meeting with Investors

Meeting Conducted

Corporate Guarantee Issued

Regulatory Penalty

Investor Meeting

Meeting with Investor

Meetings with Investors

Newspaper Advertisement

Investor Presentation

Partnership with Sandoz Aus...

FDA Response Letter

Financial Results Announcement

Personnel Changes

Investor Conference

Credit Rating Update

Investor Conference

Recognition of Consensus Gu...

Reminder Letter

Certificate under Regulatio...

Meeting with Investors

Board Meeting and Conferenc...

Biocon Biologics Partners w...

Management Resignation

Integration of Acquired Bio...

Clarification on API Business

Recognition Achieved

Meeting with Investors

Meeting Conducted with Inst...

Meeting Conducted

Credit Rating Reaffirmation

Disinvestment - Biosimilar ...

Voting results on Postal Ba...

Meetings Conducted

Meetings with Investors/Ana...

Meeting with Institutional ...

Investor Presentation

Investor Meetings

Share Certificate Loss

Presentation and Video Reco...

Related Party Transactions ...

Financial Results

Management Changes

Divestiture of Business

Divestment of Assets

Divestment of Business Units

Divestment of Business Units

Ranking in Science Magazine...

Finance Leadership Update

FDA Inspection Update

Certificate under Reg. 74 (...

Updated Meeting Schedule

Meeting Schedule

Investor Meeting

Change in Management

Board Meeting and Conferenc...

Dispute with US FDA

Partnership Agreement

Schedule Announcement

Penalty Imposed

Investor Meeting

Appointment of CEO

Resignation of Director

Investor Meeting

Expansion of Global Footprint

Acquisition of manufacturin...

Appointment of Director

Meeting with Institutional ...

Insider Trading Violations

Meeting with Investors

Meetings with Institutional...

Civil, Criminal Litigations

Financial Statements

Meetings with Analysts/Inst...

Financial Statements

Appointments, Re-appointments

Financial Statements

Financial Statements

Financial Statements

Workshop on Cities and Clim...

Financial Statements

Management Changes

Equity, Debt, VC, Private E...

Financial Statements

Financial Statements

Financial Statements

Equity Offerings

Dividend Tax Deduction

Meeting with Institutional ...

Equity, Debt, VC, Private E...

Meetings with Institutional...

New Product Launches

Sustainability Initiatives

In-person meeting

Meeting Conducted

Postal Ballot Notice and Re...

Meeting with Analysts/Insti...

Meeting Conducted

Meetings with Institutional...

Investment in API manufactu...

Meetings conducted with Ins...

Meeting with Investors and ...

No observations

Meetings with Investors/Res...

Earnings Call Transcript

Meeting held with Investor/...

Disclosure of Related Party...

Financial Results Publication

Annual Secretarial Complian...

Virtual Meetings

Financial Statements

Financial Results

Pre-Market Approval

External Links:

Data:

The U.S. FDA completed a routine inspection at Biocon Biologics facility between August 26 and September 3, 2025, issuing five procedural observations. Biocon will submit a corrective plan but expects no impact on product supply.

AI Assistant

Biocon Ltd

2025

Announcement

Find Answers

Ask about any part of the document to get insights, explanations, or key details.