BSECompany Update30 Oct 2026 · 30 Oct 2026, 12:23 am

Outcome of USFDA Inspection of Rubicon Research Ltd Manufactiring Facility at Ambernath, India

Rubicon Research Ltd · 544578

✦ AI SummaryRegulatory

Rubicon Research Ltd's manufacturing facility in Ambernath, India was inspected by the US FDA from October 21-29, 2026, resulting in 5 observations, all of which are procedural and do not relate to data integrity. The company is confident of resolving the issues in a timely manner.

Analysis Scores

Earnings Impact1/10
Growth Catalyst2/10
Governance Concern1/10
Regulatory Risk6/10
Balance Sheet Risk1/10
Liquidity Impact8/10
Market Sentiment5/10

✦ Ask a Question

Ask anything about this announcement — AI will answer based on the filing content.

0/500

Full Announcement

Rubicon Research Ltd - 544578 - Outcome Of USFDA Inspection Of Rubicon Research Ltd, Manufacturing Facility In Ambernath, India.

Attachments (1)

📄

2cc9c92f-6dd0-411b-9850-e189b3efbb71.pdf

pdf

Download →
View document text
To, To, Date: 30th October, 2026 The Manager, Listing Department The Manager, Listing Department BSE Limited National Stock Exchange of India Limited Phiroze Jeejeebhoy Towers Exchange Plaza, 5th floor, Plot no. C/1, G Block Dalal Street – Fort Bandra Kurla Complex, Bandra (East), Mumbai 400 001 Mumbai - 400 051 Scrip Code: 544578 NSE Symbol: RUBICON ISIN - INE506V01022 Subject: : Disclosure under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 – Outcome of USFDA inspection of the company’s manufacturing facility in Ambernath, India Pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, this is to inform you that the United States Food and Drug Administration (US FDA) conducted an unannounced inspection (triggered by a product filing) of the company’s manufacturing facility located at Plot No. K30/4 & 30/5, Additional M.I.D.C., Anand Nagar, Ambernath, Maharashtra, India from Wednesday, 21 October 2026 to Thursday, 29 October 2026. This was a comprehensive GMP inspection in addition to the product application under review. Upon conclusion, a Form 483 containing 3 observations with respect to system improvement and 2 observations with respect to product application under review were issued, all 5 of which are procedural in nature and do not relate to data integrity. The company is confident of working closely with the regulator to successfully conclude the evaluation in a timely manner. All our manufacturing as well as R&D facilities have now been inspected by the US FDA in the recent past and the table below summarizes the status of all our operational facilities: Facility Month of Nature of Outcome Remarks Inspection Inspection Canada Apr-26 Unannounced Zero Observations EIR Received Thane Mar-25 Announced Zero Observations EIR Received Manufacturing New Jersey, USA May-26 Prior to our Six Observations during inspection EIR Received with VAI status acquisition under previous owner just about a month before our acquisition Ambernath Oct-26 Unannounced Three observations with respect to We are confident of working closely with the system improvement and Two regulator to successfully conclude the evaluation observations with respect to product in a timely manner. application under review were issued, all Five of which are procedural in nature and do not relate to data integrity Pithampur Jul-26 Unannounced Two Observations, procedural in Response submitted in Jul-26. nature and do not relate to data EIR awaited integrity Satara Oct-26 Unannounced One Observation, procedural in We are confident of working closely with the nature and does not relate to data regulator to successfully conclude the evaluation integrity in a timely manner We will keep the stock exchanges duly informed of any further updates on this subject. Kindly take the above intimation on record. Yours faithfully, For Rubicon Research Limited Deepashree Tanksale Company Secretary M. No. A28132 Rubicon Research Limited (formerly known as Rubicon Research Private Limited) | CIN: L73100MH1999PLC119744 Registered Office: Plot No. B-75, MedOne House, Road No. 33, Wagle Estate, Thane West, PIN – 400 604, Maharashtra, India �� +91-22-61414000 / 50414000 | ����� reachus@rubicon.co.in | � www.rubicon.co.in