1. Sterling Healthcare Limited ( A Sandesara Group Company) Company Presentation
4/19/2017

2. Sandesara Group Pharmaceuticals Infrastructure Engineering Healthcare
Oil & Gas
Pharmaceuticals
Sandesara Group
Healthcare
Business interests in: Healthcare, Oil & Gas, Infrastructure, Engineering, Pharmaceuticals
4/19/2017

3. Supply of Quality Drugs Strategic Alliances Joint Ventures
Vision
To become a global player in generic pharmaceutical business with:
Supply of Quality Drugs
Strategic Alliances
Joint Ventures
4/19/2017

4. 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
4/19/2017

5. Sterling Healthcare Limited
Location Layout
Mumbai
Corporate Office
Urse, Talegaon
Sterling Healthcare Limited
API Manufacturing Facility
Baroda
4/19/2017

6. Site Layout
4/19/2017

7. Regulatory Status : Audited & Approved by Germany (July 2013)
Audited & Approved by WHO, CDSCO
(February 2012)
Audited & approved by MOH, Namibia
(August 2010)
4/19/2017

8. Approvals
WHO GMP Certificate
EU GMP Certificate
4/19/2017

9. Republic of Namibia GMP Certificate
Approvals
Republic of Namibia GMP Certificate
4/19/2017

10. Organogram 4/19/2017 Mr. Satish Shah CEO Mr.Sanjay Amla VP -Operations
Mr.Laxman Gaddamwar DGM -Operations
Mr. Bhaskar Joshi Manager -Production
Execuive-04
Officer-04
Trainee-08
Technician-18
Mr. Prasanna Wagh Asst. Manager -Warehouse
Executive-02
Mr. Sushim Jain Manager -Engineering
Executive-01
Officer-02
Technician-07
Mr. Vilas Kharat Sr.Manager -HR
Mrs. Chanda Peshave Sr. Manager-Accounts/Purchase
Executive-04
Officer -02
Mr. Rajendra Nehete Sr.GM-Quality
Mr. Manojkumar Sahu Head -QA
Mr. Bhauso Vhanmane Asst. Manager-QA
Execdutive-03
Officer-09
Trainee-03
Mr. Sikander Shaikh Sr. Executive -QC
Executive-03
Officer-07
Trainee-06
Mr. Kedar Athalye Sr. Executive -Microbiology
4/19/2017

11. Facility & Capacity 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
Tablets
110
1300
Capsules 15
180
Blister Packing 65
780
Sachet Packing
0.33
3.6
4/19/2017

12. Tablet Manufacturing
Granulation : kg / shift ( 2 granulation suites)
Blending : kg / shift ( 2 blenders )
Compression Machine
Coating Machine
Equipment
Capacity
Make
Rapid Mixer Granulator
Liters
Saral Engineering
Fluid Bed Drier
250 Kgs
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
20-90 RPM
10-70RPM
CIP Machinery
Pam Pharmaceuticals
Cadmach Machineries
Auto coater 48 Inch
60 Inch
150 Kg Kg
Gansons Limited
4/19/2017

13. Capsule Manufacturing
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
4/19/2017

14. 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.
4/19/2017

15. 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
4/19/2017

16. Thank You !
4/19/2017