Investor Presentaiton
Unwavering Regulatory and Quality foundation
Laurus Philosophy
"One Quality Standard for All Markets"
Facility
Regulatory Certifications
Year
started
Last US FDA-
Inspection status
No of USFDA
audits (since
inception)
91
Total Regulatory Audits
Kilo Lab -
R&D
USFDA, TGA, KFDA, PMDA, ANVISA
Brazil
2008
2021 USFDA
4
1,025+
935+
Unit 1
USFDA, TGA, MHRA-UK, KFDA,
WHO-Geneva, PMDA, NIP-Hungary,
Russian GMP, Mexican, ANVISA
2008
2019 EIR Received
6
44
Audits/6 Global
Quality audits
since inception
Customer audits
USFDA, BGV-Hamburg, WHO-
Regulators
(USFDA/WHO/PMDA/TGA/EMA/M
HRA)
Geneva, ZAZIBONA, Tanzania-FDA,
NDA-Uganda, PMPB-Malawi, KENYA,
Unit 2
2016
2023-
EIR Received
LO
5
MCAZ-Zimbabwe, JAZMP-Slovenia,
Ethiopia-FDA, Kazakhstan, EMA,
MFDS-Korea, Malta-MA
USFDA, WHO-Geneva, NIP-
Unit 3
Hungary, Russian GMP, Mexican,
JAZMP-Slovenia, KFDA, ANVISA
2015
2019 EIR received
4
On-going improvement in QMS and implementation across
different functions, incl. R&D, Quality and Technical operations
Unit 4
WHO-Geneva, USFDA & Mexican
2018
-
2019 EIR received
1
Unit 5
USFDA
2017
2022 EIR received
1
■ No incidents of Product Recall in the last five years
Unit 6
USFDA
2018
2018 EIR received
1
■
#51 Quality audits in H1: Regulatory #4 & Customer #47
Sriam Labs
None
2018
Nil
Nil
LSPL U-1
None
2020
Nil
Nil
11
Laurus Q2 & H1 FY 2024 Investor Presentation | October 20, 2023
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