Transcript to - STERLING Healthcare

Sterling Healthcare Limited
( A Sandesara Group Company)
Company Presentation
4/8/2015
1
Pharmaceuticals
Engineering
Infrastructure
Oil & Gas
Healthcare
Sandesara
Group
Business interests in: Healthcare, Oil & Gas, Infrastructure, Engineering, Pharmaceuticals
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Vision
To become a global player in generic pharmaceutical business with:
Supply of Quality Drugs
Strategic Alliances
Joint Ventures
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Plant Overview
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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Location Layout
Corporate Office
Mumbai
Urse, Talegaon
Sterling
Healthcare
Limited
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API Manufacturing Facility
Baroda
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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
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EU GMP Certificate
8
Approvals
Republic of Namibia GMP
Certificate
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Organogram
Mr. Satish Shah
CEO
Mr. Rajendra
Nehete
Sr.GM-Quality
Mr.Sanjay Amla
VP -Operations
Mr.Laxman
Gaddamwar
DGM -Operations
Mr. Bhaskar Joshi
Manager Production
Execuive-04
Officer-04
Mr. Prasanna
Wagh
Asst. Manager Warehouse
Executive-02
Officer-04
Mr. Sushim Jain
Manager Engineering
Executive-01
Officer-02
Mr. Vilas Kharat
Sr.Manager -HR
Executive02
Mr. Manojkumar
Sahu
Head -QA
Mrs. Chanda Peshave
Sr. ManagerAccounts/Purchase
Executive-04
Mr. Bhauso
Vhanmane
Asst. Manager-QA
Mr. Sikander Shaikh
Sr. Executive -QC
Mr. Kedar Athalye
Sr. Executive Microbiology
Execdutive03
Executive-03
Officer-02
Officer-09
Officer-07
Trainee-03
Trainee-06
Officer -02
Technician07
Trainee-08
Technician18
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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
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Tablet Manufacturing
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Granulation : 1200 kg / shift ( 2 granulation suites)
Blending : 1680 kg / shift ( 2 blenders )
Compression Machine
Coating Machine
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 Machine
37 Station
45 Station
Legacy 61 station
Cadpress IV 45 station
with CFC
10-30 RPM
10-30 RPM
20-90 RPM
10-70RPM
CIP Machinery
CIP Machinery
Pam Pharmaceuticals
Cadmach Machineries
Auto coater 48 Inch
60 Inch
150 Kg
150-350 Kg
Saral Engineering
Gansons Limited
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Capsule Manufacturing
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Blending
Octagonal blender
Encapsulation
AF 90 T with latest features installed like Empty
capsule sorter, Check weigher, Polisher, Filled
Capsules and Metal detector
Equipment
Capacity
Make
Capsule Filling
Machine AF 90T
90000
Cap/Hr
Pam
Pharmaceutical
Octagonal
Blender
1250 L
Global
Pharmaceutical
Equipment
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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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