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SHILPAMED Shilpa Medicare Ltd US FDA Inspections Announcement

Shlp

SHLP

Shilpa Medicare Ltd

(SHILPAMED)

2025 Announcement

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Summary

Strategic Investment

Reclassification Request

FDA Inspection Result

GMP Certification Received

Merger Approved

Compliance Certificate

ANVISA Audit Success

Credit Rating Revision

Merger Approval

Investor Conference

Q4 FY25 Conference Call

Annual Compliance Report

Conference Call Summary

Investor Presentation

Management Changes

Strategic Partnership

Change of Auditors

Earnings Call Scheduled

USFDA EIR Received

EMA Approval Granted

GMP Certification

GMP Certification

GMP Certification

Celltrion Settlement

Compliance Certificate

Bortezomib Launch

New Collaboration

USFDA Inspection

Investor Conference

Investor Call Recording

Revised Presentation

Investor Presentation

Earnings Call Scheduled

CEP Approval Received

BSE Rejection Notice

NSE Rejection Notice

Compliance Certificate

Product Approval

Eurasia GMP Approval

GMP Certification Received

Clinical Trial Approval

Earnings Call Transcript

Nifedipine Approval

Investor Call Recording

Monitoring Report

Investor Presentation

FDA NDA Acceptance

Earnings Call Scheduled

USFDA Inspection Results

Fast-Track Designation

Regulatory Filing

Shareholding Update

Share Pledge Disclosure

New CEO Appointment

NDU Release Announced

Successful Phase 3 Trials

Investor Conference

Monitoring Report

Q1 FY25 Earnings Call

Analyst/Investor Meet - Aud...

Earnings Presentation

Financial Results Announcement

Phase 1 Clinical Trial Comp...

Inspection Clearance

Biologics Approval

Compliance Submission

GMP Inspection Clearance

Equity Allotment

Conference Call

Business Update Call

CDMO Business Milestone

Credit Rating Upgrade

Credit Rating Revision

Credit Rating Revision

USFDA Inspection Close-Out

Re-designation Announcement

Participation Notification

Compliance Report Submission

Annalyst/Investors Call Out...

Investor Presentation

Investor Presentation

Investor Presentation

Analysts/Investors Call

Clinical Trial Announcement

Merger Approval

Compliance Certificate Subm...

Compliance Certificate

Certificate Submission

Equity Shares Allotment

Companys issue price determ...

QIP Announcement

Announcement: Qualified Ins...

Management Appointment

USFDA Inspection

Europe Approval for Varenic...

Application Submission

Conference Call Recording U...

Investor Presentation

Conference Call

EU GMP Inspection

Arbitration Award

Product Code Grant

Europe Approval for Amifamp...

Compliance Certificate Subm...

Approval by TGA, Australia ...

Stake Sale Agreement

Investor Presentation

Reclassification to Public ...

Conference Call

Conference Call

Acquisition of Pilnova Phar...

Merger of Equals

GMP Inspection Passed

Submission of Compliance Ce...

Newspaper Publication

Reclassification Request

AGM Notice Dispatched

Clears PMDA Japan, GMP Insp...

MHRA Approval for Betahisti...

Release of Pledge

Release of Pledge of Shares

GMP Inspection Cleared

Conference Call

Financial Statements

Financial Statements

Conference Call

New Product Launches

Equity Offerings

Financial Statements Public...

Compliance Report Filing

Financial Results

Conference Call

Clearance with VAI Classifi...

External Links:

Data:

Shilpa Pharma Lifesciences Limited, a subsidiary of Shilpa Medicare Ltd, received an Establishment Inspection Report (EIR) from the USFDA, classifying the site as Voluntary Action Indicated (VAI) after an inspection conducted from March 3-7, 2025.

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Shilpa Medicare Ltd

2025

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