www.indeus.

in

A state-of-the-art
pharmaceutical research
and development facility,
established in 2009
INTRODUCTION Indeus
Life Sciences
State-of-the-art pharmaceutical research and development facility, established 2009

Nordic Group (France) Vision to Establish Indeus Life Sciences in Mumbai, India
• Provides high-quality cost effective R&D services to both internal.(Nordic Drugs, Disphar History
International & Q Pharma) and external partners in the pharmaceutical business (2009-2022)
• To Carter regulated markets (EU, US) and the Indian market.
• To undertake simultaneously on average 15 to 20 development projects on a yearly basis.
• Also supports the Group with low volume commercial manufacturing.
• Provides support for Regulatory Affairs to the team in NL.

Nordic Group, France Decide to exit from this business Model in year 2019, in Year 2020 the company
was take over by Genocare Pharma, India

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INTRODUCTION Indeus
Life Sciences
Indeus Life Sciences is engaged in the following activities for pass 10 years:

• Formulation development and process validation

• Analytical method development and method validation History

(2009-2022)
• Technology transfer to CMO

• Stability studies as per ICH guidelines

• Manufacturing of Clinical/Bio- batch for BE/Clinical studies

• Commercial manufacturing of tablets, Pellets, Powder and Sachet for export

market with to Europe approved facility.

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 Indeus
Life Sciences

Indeus life
Science is a
state-of-the-art
pharmaceutical
Product
development
laboratory and
manufacturing
facility in
Mumbai and is a
subsidiary of
the Geno Care
Pharma

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INDIUS FACILITY Indeus
Life Sciences
• The facility is located in Mulund (west), Mumbai and is easily accessible from all parts of
the city.
• The facility has a total area of 1620 (m2)

Department Area (m2)

Administrative block 560
Analytical Laboratory 260
R&D Laboratory 230
Manufacturing (GMP) Area 300
Warehouse 270
Total 1620
FACILITIES

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TEAM Indeus
Life Sciences

CORE TEAM

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REGULATORY APPROVALS Indeus
Life Sciences
• Indeus is approved by the state FDA for manufacture of batches for human consumption
(Lic No. MH004704, valid from 03.06.2021 to 02.06.2026).

• Indeus has been inspected and approved by Dutch Health Inspectorate IGZ for manufacture
REGULATORY
of tablets and granules
APPROVALS
• First inspection in February 2012
• Follow-up inspection in Nov 2014
• Follow-up inspection in Mar 2018
• Renewed upto Dec 2022

• The facility is also approved by all the statutory and regulatory authorities including: City
Municipal Corporation, Directorate of Industrial Safety, State Pollution Control Board and
Narcotics Control Bureau.
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INDEUS LIFE SCIENCES EU APPROVED FACILITY Indeus
Life Sciences
• It is a State-of-the-art pharmaceutical research and development facility, operational for
more than 10 years.
• Provides high-quality cost effective R&D services to both internal and external partners in
the pharmaceutical business
FACILITY
• Has dedicated and trained staff of approximately 45 people, having necessary skills &
APPROVALS
knowledge of the requirements of regulated markets (EU, US) and the Indian market
• Is equipped with modern production and analytical equipment to undertake
simultaneously on average 12 development projects on a yearly basis
• Was inspected and approved by the EU authorities thrice for compliance as per EU
guidelines. The latest successful inspection was completed in 2018
• Supports the Group with small volume commercial manufacturing
• Provides support for Regulatory Affairs to the team in EU

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INDEUS - CAPABILITY Indeus
Life Sciences
• Technical capability
Based on the various equipment available, the following types of formulations can be
developed:
• Tablets (coated and uncoated)
• Immediate Release
CAPABILITIES
• Modified Release
• Effervescent
• Orodispersible
• Chewable
• Bi-layered tablets
• Capsules
• Granules
• Pellets
• Oral solutions, suspensions & Sterile Preparation
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INDEUS - QUALITY OBJECTIVE Indeus
Life Sciences
• To provide products and services which consistently meet all appropriate technical
standards, regulatory and legal requirements, as well as customer expectations and to
deliver these in a cost effective and timely manner.
QUALITY
OBJECTIVE
• Quality is mandatory and is supported by the top management and coordinated by Quality
Assurance.

• All personnel are responsible for quality in their job functions, to effectively implement the
quality system.

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INDEUS - QUALITY MANAGEMENT SYSTEM Indeus
Life Sciences
• Quality Management System is based on:
• EU Guidelines
• Schedule M (Drugs & Cosmetics Act, India)
QUALITY
Quality is achieved through a system of procedures, which are defined in controlled
MANAGEMENT
documents: SYSTEM
• SMF, Quality Manual & VMP
• Department System Manuals & SOPs
• By providing training
• Induction, Orientation, On the Job & External Programs

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INDEUS - ANALYTICAL LAB VIEW Indeus
Life Sciences

QC/ ANALYTICAL
LAB VIEW

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INDEUS - THE WET CHEMISTRY LABORATORY Indeus
Life Sciences

QC / ANALYTICAL
WET CHEMISTRY
LABORATORY

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INDEUS - THE HPLC ROOM Indeus
Life Sciences

QC / ANALYTICAL
HPLC ROOM

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INDEUS - QUALITY MANAGEMENT SYSTEM Indeus
Life Sciences
Stability
• Stability samples maintained at different conditions as per ICH guidelines:
25C/60%RH; 30C/75%RH; 40C/75%RH
• Photo-stability chamber STABILITY
• All chambers are GMP-design with insides of SS316
• Stand-by refrigeration and dehumidification system
• Continuous monitoring of temperature and humidity
• Alarm system with GSM mobile communication / audio alarm
• Sample testing as per appropriate stability specifications.

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INDEUS - PRE-FORMULATION LAB Indeus
Life Sciences

R&D
PRE-
FORMULATION
LAB

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INDEUS – R&D Indeus
Life Sciences
Activities
• Pre-formulation studies for development of new generic products following QbD
approach.
R&D
• Identification of critical manufacturing process parameters and for the formulation
ACTIVITIES
through DoE
• Manufacture of batches on a laboratory scale and monitoring for stability studies
• Technology Transfer to Contract Manufacturing Organization

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INDEUS - BI-LAYERED TABLET PRESS Indeus
Life Sciences

R&D
BI-LAYERED
TABLET PRESS

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INDEUS - GLATT GPCG 1.1 FBP Indeus
Life Sciences

R&D
FBP
GLATT
GPCG 1.1

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INDEUS - NICA EXTRUDER & SPHERONIZER Indeus
Life Sciences

EXTRUDER &
SPHERONIZER
NICA

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INDEUS - THE CORRIDOR OF THE CGMP AREA Indeus
Life Sciences

MANUFACTURING
GMP AREA
CORRIDOR

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INDEUS - MANUFACTURING (GMP) Indeus
Life Sciences

• Activities

• Manufacture batches for Process Optimization

MANUFACTURING
GMP
• Carry out Process Validation Studies ACTIVITIES

• Manufacture Pilot / Pivotal Bio-batches and Scale-up Batches

• Manufacture of Commercial Batches.

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INDEUS - MANUFACTURING (GMP) Indeus
Life Sciences
Facility - Main Features
• Qualified ISO Class 8 environment with temperature & pressure differential control,
qualified as per standard procedure
MANUFACTURING
• Entry and Exit procedures GMP
MAIN FEATURES
• Separate flow of materials
• Epoxy flooring in formulation area, which is chemically resistant and facilitates easy
cleaning
• Coving at all joints to minimize dust accumulation
• Manufacturing equipment from established leading manufacturers (Glatt, Korsch,
GEA)

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INDEUS - GRANULATION ROOM Indeus
Life Sciences

MANUFACTURING
GMP
GRANULATION
ROOM

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INDEUS - KORSCH XL 100 PROTM TABLET PRESS Indeus
Life Sciences

KORSCH
XL 100 PROTM
TABLET PRESS

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INDEUS - PEARLCOAT™ AUTOCOATER 12, 15 AND 18” PANS Indeus
Life Sciences

MANUFACTURING
GMP
PEARLCOAT™
AUTOCOATER
PANS
12, 15 & 18”

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INDEUS - IMA BLISTER PACKING MACHINE Indeus
Life Sciences

MANUFACTURING
GMP
BLISTER
PACKING
MACHINE
IMA

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 INDEUS LIST MANUFACTURING (GMP) – KEY EQUIPMENTS Indeus
Life Sciences
Equipment & model Make Country of manufacture
Comill Chamunda India
Autocoater - Pearl Coat Ci – 450 Chamunda India
MANUFACTURING
Rapid Mixer Granulator - CPMRMG - IB15 Chamunda India GMP
KEY
Vibro Sifter Bowman Archer India
EQUIPMENTS
Conta Blender Chamunda India
Multi-mill Chamunda India
Fluid Bed Processor, FBE – 25 PAM – Glatt India
Clinipack® blister packing machine IMA – PG India
Rotary instrumented tablet press Korsch Germany
RLF booth Airpac India
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 OUR PRODUCT LIST Indeus
Sr.No. R & D Projects Remarks Life Sciences
1 Anagrelide tablets: 0.5 mg, 0.75mg, 1.0mg Tablets Commercialized
2 Loperamide HCl and Simethicone, 2-125mg Tablets Commercialized
3 Acetylsalicylic acid ODT: 80 mg / 100mg Completed but not commercialized
Batch optimisation was not done
4 Loperamide HCl and Simethicone, 2-125mg Chewable Completed but not commercialized
5 Loperamide ODT 2 mg Completed but not commercialized
6 Betahistine dihydrochloride tablets: 8mg/16mg/24mg/48mg Completed but not commercialized PRODUCT LIST
7 UDCA enteric coated pellets 250mg Completed but not commercialized
8 Desloratadine Oral Solution Completed but not commercialized
9 Gliclazide 30/60/90mg MR Tablet Completed but not commercialized
10 Aspirin Granules 500mg/1000mg Completed but not commercialized
11 Mesalamine Granules 1000/2000/4000mg Completed but not commercialized
Flecainide Acetate IR Tblet 50mg Completed but not commercialized
12
Batch optimisation not done
13 Domperidone ODT 10mg and 20mg Completed but not commercialized
14 UDCA capsule 250mg Completed but not commercialized
15 Metformin HCl granules 500 gm 1000mg Completed but not commercialized
Frovatriptan film coated tablets 2.5mg Completed, but not commercialized
16 (stopped during method validation activity)

17 Acetylcysteine powder for oral solution (200mg, 400mg & 600mg) Completed but not commercialized www.indeus.in
OUR PRODUCT UNDER PIPE LINE Indeus
Life Sciences
• PARACETAMOL GRANULES 250MG/500MG/1000MG
• FUMARIC ACID ESTERS TABLETS
• ENTECAVIR ORAL SOLUTION 0.05MG/ML
• ENTECAVIR TABLETS 0.5, 1.0 MG
• ELETRIPTAN ORODISPERSIBLE TABLET 20MG, 40MG PRODUCT
• ELETRIPTAN HBR FILM COATED TABLET 20 MG, 40MG DEVELOPMENT
• IVABRADINE HCL FILM COATED TABLETS 5MG AND 7.5MG PIPELINE
• TRAMADOL HCL AND PARACETAMOL TABLETS 37.5/325 MG
• TRAMADOL HCL AND PARACETAMOL ORODISPERSIBLE TABLETS: 325MG/37.5MG
• PHYTOMENADIONE 0.5MG CHEWABLE TABLET (VITAMIN K)
• FROVATRIPTAN FILM COATED TABLETS 2.5 MG
• IBUPROFEN GRANULES 600 MG
• FLECAINIDE ACETATE IR TABLET
• TRAMADOL HCL ODT
• DOCUSATE SODIUM AND SORBITOL ENEMA

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INDEUS – AUDITED BY Indeus
Life Sciences

AUDITED BY

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OUR CLIENT LIST Indeus
Life Sciences

CLIENT LIST

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32
OUR PARTNERS ROW MARKET Indeus
Life Sciences

PARTNERS
ROW MARKETS

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INDEUS – SERVICE & SUPPORT Indeus
Life Sciences
• Note : All statutory permits and licenses are in place.

• For additional information and further clarification, please correspond at following

SERVICE
email: &
SUPPORT

• rndhead@indeus.in
• Tel: -91-9987898131
• Website: www.indeus.in; www.genocarepharma.com

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 Indeus
Life Sciences

THANK YOU!

THANK YOU!

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