BSECompany Update1d ago · 14 Aug 2026, 08:17 pm
Investor Presentation for the Quarter ended June 30, 2026 is attached herewith
Gufic Biosciences Ltd · 509079
✦ AI Summary▲ PositiveResults
Gufic Biosciences Ltd has released an investor presentation for the quarter ended June 30, 2026, highlighting its Indore facility's progress, including the completion of qualification phases, product permissions, and capacity utilization. The company is on track to achieve its targets and is expanding its capabilities to manufacture long-acting depot products and lipid-based antifungals.
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Earnings Impact6/10
Growth Catalyst8/10
Governance Concern2/10
Regulatory Risk3/10
Balance Sheet Risk4/10
Liquidity Impact7/10
Market Sentiment8/10
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Gufic Biosciences Ltd - 509079 - Announcement under Regulation 30 (LODR)-Investor Presentation
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239/LG/SE/AUG/2026/GBSL
August 14, 2026
To, To,
BSE Limited National Stock Exchange of India Limited
Phiroze Jeejeebhoy Towers, Exchange Plaza, Bandra Kurla Complex,
Dalal Street, Fort, Mumbai – 400 001 Bandra (E), Mumbai – 400 051
Scrip Code: 509079 Scrip Symbol: GUFICBIO
Subject: Investor Presentation
Dear Sir/Madam,
Pursuant to Regulation 30 of Securities and Exchange Board of India (Listing Obligations and
Disclosure Requirements) Regulations, 2015, please find enclosed herewith the Investor
Presentation on Unaudited Financial Results of the Company for the quarter ended June 30,
2026.
Kindly take the same on record.
Thanking You,
Yours truly,
For Gufic Biosciences Limited
Ami Shah
Company Secretary & Compliance Officer
Membership No. A39579
Encl.: As above
Investor Presentation
Delivering Care & Cure
For Q1FY2027
Safe Harbor
This presentation has been prepared by and is the sole responsibility of Gufic Biosciences Limited (the “Company”). By accessing this presentation, you are
agreeing to be bound by the trailing restrictions.
This presentation does not constitute or form part of any offer or invitation or inducement to sell or issue, or any solicitation of any offer or recommendation to
purchase or subscribe for, any securities of the Company, nor shall it or any part of it or the fact of its distribution form the basis of, or be relied on in connection
with, any contract or commitment thereof. In particular, this presentation is not intended to be a prospectus or offer document under the applicable laws of any
jurisdiction, including India. No representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy,
completeness or correctness of the information or opinions contained in this presentation. Such information and opinions are in all events not current after the
date of this presentation. There is no obligation to update, modify or amend this communication or to otherwise notify the recipient if the information, opinion,
projection, forecast or estimate set forth herein, changes or subsequently becomes inaccurate.
Certain statements contained in this presentation that are not statements of historical fact constitute “forward-looking statements.” You can generally identify
forward looking statements by terminology such as “aim”, “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “objective”, “goal”,
“plan”, “potential”, “project”, “pursue”, “shall”, “should”, “will”, “would”, or other words or phrases of similar import. These forward-looking statements involve
known and unknown risks, uncertainties, assumptions and other factors that may cause the Company’s actual results, performance or achievements to be materially
different from any future results, performance or achievements expressed or implied by such forward-looking statements or other projections. Important factors
that could cause actual results, performance or achievements to differ materially include, among others: (a) our ability to successfully implement our strategy, (b)
our growth and expansion plans, (c) changes in regulatory norms applicable to the Company, (d) technological changes, (e) investment income, (f) cash flow
projections, and (g) other risks.
This presentation is for general information purposes only, without regard to any specific objectives, financial situations or informational needs of any particular
person. The Company may alter, modify or otherwise change in any manner the content of this presentation, without obligation to notify any person of such change
or changes.
Q1 FY27 Business & Financial Highlights
Indore Facility update: The Manufacturing Platform
Timeline of our phased approach
We have built one of the most advanced lyophilized
injectable facilities, commenced production in Milestone Target Status & Commentary
October 2024 Installation & Operational ✅Completed –facility meets WHO GMP, EU GMP, ANVISA,
October 2023
Qualification (IQ/OQ) MHRA, USFDA design standards
Designed for WHO GMP, EU GMP, ANVISA, MHRA, Performance Qualification (PQ) ✅Completed with multiple container trials; parameters
Dec 2023 –Jun 2024
and USFDA standards, it houses: All Lines & Utilities locked
Lyophilized vials – 5 million/month Media Fills
Jul 2024 –Oct 2024 ✅Completed for all four lines; sterility validated
Liquid vials – 6 million/month (Aseptic Process Simulations)
Ampoules – 10 million/month
Product Permissions from State FDA Ongoing 🟡 203 approvals received to date; more in pipeline
The qualification phase is behind the site. Q1 work Tech Transfer for existing products 🟡 Completed for 40 products;
moved to capability extension — the depot and from Navsari & Process Validation Oct 2024 –ongoing stability studies in progress. 27 more products under
Batches for initial products development
microsphere suite is at the verge of completion,
enabling manufacture of long-acting depot Vendor Audits 🟡 20+ completed, more lined up; CMO contracts
H1-FY26
Indian Pharma Majors commenced
presentations
30% Capacity Utilization FY26 🟡 On-track
Set-up commenced for a spray-dried route to a lipid-
based antifungal, alongside qualification of a Global Regulatory Clearance
conventional route for the same format. These are
formats very few Indian sites operate; both are EU GMP & UK MHRA FY27 🟡 EU audit completed; certification awaited
targeted to become operational during the year.
🔵Filed with US authorities on behalf of a client to trigger
US FDA FY29
inspection; Gufic participates as a pure-play CDMO partner
Direction: Scale-up is deliberately paced. The site’s cost base is already in the reported numbers; the operating leverage it was built to create sits behind the certifications now in progress.
Indore Plant: The Journey So Far
Gufic Advantage
What We Delivered Quarter by Quarter
Fully Integrated Injectable Platform
Quarter Milestone Detail / Evidence Barrier Why It Matters
Q4 FY25 Commercial production
Oct 2024 first batch; plant capitalized Q3 FY25 One of the largest Indian companies that can manufacture
(Capitalized) commenced Lyophilisation at scale
lyophilized injectables at scale.
Navsari saturated; all incremental growth =
Q1 FY26 Indore. High volume molecules shifted in phase
First revenue contribution Lyophilized + Liquid Vials + Ampoules + Microspheres + NDDS (DCB,
(Apr-Jun '25) 1. 145 State FDA approvals. 9 Lyo + 3 Liquid + 3
Multi-format complexity DCS) + Depot —very few companies can run this breadth under one
Ampoule tech transfers done; 8 in progress
roof
40 tech transfers
Q2 FY26 Product mix shifted to volume products. 18 CMO
completed; 27 under
(Jul-Sep '25) vendor audits completed.
development WHO GMP + EU GMP + UK MHRA + ANVISA + TGA + Health Canada +
Regulatory multi-accreditation
Russian GMP + Oman GMP + Iraq GMP + UAE GMP —10+
(Indore + Navsari)
203 State FDA approvals received. 20+ vendor
concurrent accreditations = moat against new entrants
Q3 FY26 On track for 30% capacity
audits. EU competent authority audit completed
(Oct-Dec '25) utilization
first week December 2025.
Indore batch sizes (100K+ vials/batch) vs Industry avg(40K) = 2.5x
Scale up of phase 1
GLP-1 validation batches (for big pharma client) Batch size economics unit economics for export (QP release cost fixed per batch, not per
Q4 FY26 molecules commenced in
executed in Jan 26. CMO client migration vial)
(Jan-Mar '26) CMO; regulatory audit
underway from Navsari Unit-2 to Indore
focus
Depot and microsphere suite nearing
20+ Indian pharma majors have audited or are CMO partners —this
Q1 FY27 Capability extension and completion; spray-dried and conventional routes CDMO credibility
is the ultimate third-party quality validation
(Apr-Jun '26) regulatory sequencing for a lipid-based antifungal under set-up;
contract-client migration continuing
I. Hospital Injectable Platform. Therapy Focus: Anti-Microbials, Immunology & Cardiac Critical Care
A. Critical Care Cluster B. Sparsh
Hospital-first
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