Sterling Healthcare Limited ( A Sandesara Group Company)

Company Presentation

104/20/23

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Pha

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Infr

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Eng

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SandesaraGroup

Business interests in: Healthcare, Oil & Gas, Infrastructure, Engineering, Pharmaceuticals

VisionVision

Supply of Quality Drugs

Strategic Alliances

Joint Ventures

To become a global player in generic pharmaceutical business with:

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Plant Overview

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Pharmaceutical Contract Manufacturing of Oral Solid Dosage Formulations (Tablet / Capsule / Granules)

Plot Size: 21,000 m² Facility with built-up area of 5,077 m²

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Sterling Healthcare

Limited

Location Layout Corporate Office Mumbai

Baroda

API Manufacturing Facility

Urse, Talegaon

Site Layout

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Regulatory Status :

Audited & Approved by Germany (July 2013)

Audited & Approved by WHO, CDSCO (February 2012)

Audited & approved by MOH, Namibia (August 2010)

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Approvals WHO GMP Certificate EU GMP Certificate

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Approvals

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Republic of Namibia GMP Certificate

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Organogram

Facility & Capacity

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Two granulation suites (Approx. 219 Sq.m) Two blending suites ( Approx. 47 Sq.m) Four compression areas ( Approx. 130 Sq.m) Two encapsulation areas ( Approx. 80 Sq.m) Two coating areas (Approx. 124 sq.m) Five packaging lines : 4 Blister and 1 Bulk

Packing ( Approx. 134 sq.m)

CAPACITIES Per month (Single Shift)(Million)

Per annum(Single Shift)(Million)

Tablets 110 1300

Capsules 15 180

Blister Packing

65 780

Sachet Packing

0.33 3.6

Tablet Manufacturing

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Equipment Capacity Make

Rapid Mixer Granulator 180-480 Liters Saral Engineering

Fluid Bed Drier 250 Kgs Saral Engineering

Fluid Bed Processor 500 Lts Pam-Glatt

Compression Machine37 Station45 StationLegacy 61 stationCadpress IV 45 station with CFC

10-30 RPM10-30 RPM20-90 RPM10-70RPM

CIP MachineryCIP MachineryPam PharmaceuticalsCadmach Machineries

Auto coater 48 Inch 60 Inch

150 Kg150-350 Kg

Saral EngineeringGansons Limited

Granulation : 1200 kg / shift ( 2 granulation suites) Blending : 1680 kg / shift ( 2 blenders ) Compression Machine Coating Machine

Capsule Manufacturing

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Equipment Capacity Make

Capsule Filling Machine AF 90T

90000 Cap/Hr

Pam Pharmaceutical

Octagonal Blender

1250 L Global Pharmaceutical Equipment

Blending Octagonal blender Encapsulation

AF 90 T with latest features installed like Empty capsule sorter, Check weigher, Polisher, Filled Capsules and Metal detector

Features of Formulation Plant Individual processing areas serviced by dedicated AHU’s and

differential pressure maintained to prevent cross – contamination Tablets manufacturing areas : Temp. NMT 250 C and RH NMT

60% Capsules manufacturing areas : Temp. NMT 250 C and RH

NMT 45%

Manufacturing area classification complying to Grade D/Class 100,000.

HEPA filtered air is provided to Manufacturing areas. Total 36 numbers of AHUs, 05 Numbers of Dehumidifiers and 07 Numbers of Ventilation Units are provided in the HVAC system.

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Quality Systems

All activities as per laid down SOPs and protocols

Training program (Induction, Need based, Systems and Incident based)

Batch manufacturing through controlled Batch Manufacturing records

Deviation Management, Change Control Management and CAPA

Use of approved and validated test procedures with controlled work sheets

Investigation of Out of specification results

Structured stability program

Handling of Market complaint and Product recall

Annual Product Quality Review

Self Inspection

Quality Risk Management

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Thank You !

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