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